StemCell Therapy

Actress Kirron Kher is suffering from Multiple Myeloma, a type of blood cancer. Read to know the causes, symptoms, treatment, risks and more about the fatal disease.

New Delhi | Jagran Health Desk:Kirron Kher is suffering from Multiple Myeloma which is a type of blood cancer. The actress's husband Anupam Kher made an official announcement about her illness through a post on his official social media handle.

He wrote,"Just so that rumours don't get the better of a situation Sikandar and I would like to inform everyone that Kirron has been diagnosed with multiple myeloma, a type of blood cancer. She is currently undergoing treatment and we are sure she weill come out of this stronger than before. We are are very blessed that she is being looked after by a phenomenal set of doctors. She's always been a figher and takes things head on. She's all heart nd that's why she has so many people that love her. So keep sending your love to her in your prayers and in your heart. She is well on her way to recovery and we thank everyone for their support and love. Anupam and Sikander."

What is Multiple Myeloma?

Multiple Myeloma is a progressive hematologic disease. It is a cancer of plasma cells, which are type of blood cells in the bone marrow. When cells multiply unconditionally, they crowd out normal cells, therefore the body does not work the way it should. This disease causes damage to the immune system, bones, red blood cells etc. Cancerous plasma cells gather in the bone marrow, produce abnormal proteins, which causes complications.

What are the symptoms of Multiple Myeloma?

When the disease is in its early stage there may be no signs of symptoms as such. But some of the visible symptoms of this disease are as follows:

Diagnosis of Multiple Myeloma

Doctors advise diagnostic tests considering many factors such as:

Tests of Multiple Myeloma

Here are some of the tests which are done for diagnosis of multiple myeloma:

Causes of Multiple Myeloma

Although the causes of myeloma are not very clear. But, the disease occurs when abnormal cells multiply rapidly, they accumulate and crowd out healthy blood cells. Abnormal antibodies (monoclonal protein or M proteins) produced by myeloma cells cause problems, such as damage to kidneys, bones etc.

Complications during Multiple Myeloma

Risk Factors ofMultiple Myeloma

Treatment ofMultiple Myeloma

Treatment of Multiple Myeloma includes medication, chemotherapy, radiation, corticosteroids, stem-cell transplant etc.

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Kirron Kher is suffering with Multiple Myeloma: Know the causes, symptoms and more about this type of blood cancer - Jagran English

The use of decitabine was linked to improved platelet counts and survival rates in patients with refractory prolonged isolated thrombocytopenia (RPIT), which can be a complication of allogeneic hematopoietic cell transplantation (HCT), according to the results of a study recently published in Blood Advances.

Isolated thrombocytopenia is a frequent and severe complication of HCT that is associated with worse outcomes, the study investigators explained in their report. According to the investigators, RPIT has been thought to relate to such factors as disease recurrence, treatment history, factors related to the transplant donor, and other transplantation complications. However, they suggested that the absence of a consistent definition for prolonged isolated thrombocytopenia has hindered understanding of its patterns.

This prospective, phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT02487563) included patients who had undergone allogeneic HCT and developed RPIT and who were treated at any of 6 participating hematology centers in China.

Patients were randomly assigned across 3 treatment arms: low-dose decitabine with recombinant human thrombopoietin (arm A), decitabine only (arm B), or conventional treatment (arm C). Platelet response at 28 days following treatment was the primary study endpoint, and this was defined as a sustained increase of 30 x 109/L or more, independent of transfusion for 3 days.

Across the participating centers, 2616 allogeneic HCT recipients were identified, of whom 256 had developed thrombocytopenia for more than 60 days following transplantation, and 97 met criteria for study inclusion. A total of 91 patients were evaluated for response.

The response rate for arm A was 66.7%, for arm B it was 73.3%, and for arm C it was 19.4%. Arms A and B were not statistically different for response (P =.779), while the response rate for arm C was statistically lower than the others (P <.001).

At a median follow-up of 11 months, the estimated 1-year survival rates were 64.4% for arm A and 73.4% for arm B, which were both greater than in arm C (41.0%). When the decitabine arms were combined, the survival rate was 68.2%, which was significantly higher than 1-year survival in arm C (P =.008).

The treatment arms receiving decitabine also showed significantly elevated total megakaryocyte counts, platelet-shedding megakaryocytes, and megakaryocyte polyploidy, while arm C did not. This suggested there are improvements in megakaryocyte proliferation and maturation with decitabine, according to the investigators.

In conclusion, this multicenter randomized study demonstrates the efficacy and safety of decitabine for patients with RPIT after HCT, with improved response and prolonged survival, the study investigators wrote in their report.

Reference

Tang Y, Chen J, Liu Q, et al. Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial. Blood Adv. 2021;5(5):1250-1258. doi:10.1182/bloodadvances.2020002790

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Decitabine Improved Outcomes for Patients With Refractory Prolonged Isolated Thrombocytopenia - Hematology Advisor

Lake in the Hills Police Officer Mike Domagala with one of his children. | Provided Photo.

A Lake in the Hills police officer with 20 years of service, who is a father of four kids, says he will no longer be able to work as he battles a rare blood cancer, and a fundraiser has been started for him.

Mike Domagala began his law enforcement career in Fox River Grove in 2002. He was hired by the Lake in the Hills Police Department in 2012.

Domagala, 43, was diagnosed in July with multiple myeloma, which is a rare blood cancer that is not curable but is treatable.

According to the Mayo Clinic, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. The cancer cells produce abnormal proteins that can cause complications.

Domagala is married and has four children, ages 5, 12, 16, and 23. At the onset of the cancer discovery, he had to have a pelvic biopsy, two bone marrow biopsies, blood work, PET scans, CT scans, and MRIs, according to a GoFundMe account.

Domagala has undergone multiple cycles of chemotherapy that started on August 4 and then a stem cell transplant in December.

He has not been able to patrol as an officer since his diagnosis. On March 25, Domagala said in an update that he had his 100-day post bone marrow appointment, which went well.

I also had my hematologist appointment for my maintenance therapy which will be a chemo pill every day and a bone healing transfusion once a month. The overwhelming support my family and I have received through this has been amazing and helps me continue to fight through this difficult time, he said.

Domagala said in February that he was optimistic about getting back to work. However, he said in his March 25 update that his doctor told him he would not be able to return to working the streets as a police officer.

I have been a police officer for almost 20 years and have always wanted to be since I was a child. I have no idea what I am going to do but I will figure it out as this is still sinking in, he said.

Fellow police officer Erik Watters started a GoFundMe account for Domagala in November and it continues to bring in donations from the public.

The fundraiser money is going towards uncovered medical expenses, travel expenses for treatments and to help his family with everyday expenses.

Mike maintains a strong fighting spirit and finds his strength in his love for his family. Mikes greatest concern is in continuing to provide for his family while he covers all of his uncovered medical expenses, Watter said.

The GoFundMe has a $50,000 goal and has raised $28,800 so far as of Thursday.

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Lake in the Hills police officer and father of 4 kids battling rare cancer forced to retire - Lake and McHenry County Scanner

The pancreas, saysGary Lewis, an endocrinologist at Toronto General Hospital and director of the Banting & Best Diabetes Centre at the University of Torontos Temerty Faculty of Medicine, is like an exquisitely sensitive and perfectly networked computer.

Second by second,he notes,the pancreassecretesjust the right amount ofinsulinor glucagontolower or raiseblood sugarintotheportal veinthat leadsdirectlyto the liver, the site of key metabolic processes. Insulingis then distributedto every tissue in the body via general circulation.

Thats one reason a cure for diabetes has proven elusive 100 years after the discovery of insulin.

Another big reason is the complexity of how the disease arises. In type 1 diabetes, the immune system destroys the insulin-producing beta cells of the pancreas, creating a life-threatening spike in blood sugar. Type 2 diabetes usually comes on more slowly, as the body becomes resistant to insulin or the pancreas cant produce enough of it.

Genetics play a role in both types. Exposure to viruses and other environmental effects may be a factor in type 1. Lifestyle factors, including weight gain and physical inactivity, are strongly linked to type 2.

The bottom line, says Lewis, is that diabetes is a multifactoral disease, and were not close to a cure.

Ask about treatments, though, and Lewis gets excited.

The last two decades have brought a plethora of clinical and research advances, from new drugs to boost and sensitize the body to insulin and promote weight loss, to lifestyle interventions that improve diet, continuous monitoring of blood sugar, long- and short-lasting insulin, better insulin pumps, pancreatic transplantsand pre-clinical stem cell and immunosuppressive therapies.

Progress on treatments has been fantastic, especially for type 2, Lewis says. Im very, very hopeful.

The distinction between treatment and cure in medicine is often unclear. And for the 3.6 million Canadians living with diabetes, the distinction matters less and lessif the goal is a full and healthy life.

Type 2 diabetes accounts for about 90 per cent of diabetes cases in Canada. Prevalence is rising, but Canadians with type 2 diabetes are living longer and have fewer diabetes-related complications.

The clinic doesnt look like it did 30 years ago, says Lewis, who mainly treats patients with type 2. We see fewer amputees, less blindness. Patients are generally healthier, and their prognosis is often excellent if they maintain their blood sugar target and other key parameters.

Weight loss is a cornerstone of treatments to lower blood sugar, and recent research has strengthened the link between weight reduction and type 2 diabetes management. Some people with type 2 can lose weight and control blood sugar through dietary changes and exercise alone.

Bariatric surgery is very effective for weight loss and often results in diabetes remission, although it comes with surgical risks and is expensive.

If we could prevent obesity, we could greatly reduce the incidence of type 2, Lewis says. And experiments have shown wecan get a remission withlifestyle changes, so we know what works.

The problem is broad implementation.

Ive tried to lose weight and I know how difficult it can be, especially in an environment of convenient and inexpensive calories, Lewis says. Moreover, factors such as income, education, ethnicity, access to healthy food and living conditions can make lifestyle changes that curb obesity nearly impossible.

Social determinants of health are overwhelmingly the most important influence on who gets type 2 diabetes, and how well or poorly they do with it, Lewis says.

Fortunately, dozens of new drugs for diabetes have hit the market in the last two decades.

Medications for weight loss round out the armamentarium, and some also protect against kidney damage and lower cardiac risk. Current therapies can reduce body weight up to 10 per cent, although a loss of 20 per cent or more would have a greater effect on outcomes for patients with type 2 diabetes, saysJacqueline Beaudry, an assistant professor of nutritional sciences at U of T who studies links between obesity, hormones and diet.

Beaudry is probing the biology that underpins these medications, including the gut hormones GLP-1 and GIP. They control blood glucose and reduce appetite, but scientists are unsure how.

If we could understand their mechanisms of action, we could design better drugs, Beaudry says.

For people with type 1 diabetes, continuous glucose monitors, insulin pumps and even automated closed-loopsystems that run on mobile apps to deliver insulin as-needed have radically changed the patient experience.

Sara Vasconcelos left),an assistant professor at U of Ts Institute of Biomedical Engineering, has worked withCristina Nostro (right), an associate professor in the department of physiology,and her team in the McEwen Stem Cell Institute at UHNto extend the survival and functionality of pancreatic precursor cells generatedfrom human stem cells.

Cell therapy could prove more liberating still.

University labs and biotechs are working on implantable devices that house insulin-producing cells derived from stem cells.

To that end,Cristina Nostro, an associate professor in the department of physiology in the Temerty Faculty of Medicine,and her team in the McEwen Stem Cell Institute at University Health Network recently discovered a more efficient way to generate and purify pancreatic precursor cells from human stem cells in the lab.

They have also found a way to vascularize those cells by working withSara Vasconcelos, an assistant professor at U of Ts Institute of Biomedical Engineering. Together, they have extended the survival and functionality of the cells in animal models of diabetes.

The biggest problem with these therapies is that the immune system rejects them. The same challenge currently hinders pancreas and islet transplants.

The immune system is an amazing machine, were luckyits so good, says Nostro. But its very difficult to control when it goes awry, as in autoimmune conditions.

Nostro is working with immunologists at the university on a method to protect insulin-producing beta cells from immune rejection, and she says many researchers in the field are now focused on immune-protective approaches.

Another strategy for type 1 diabetes is to tamp down the autoimmune response before the disease progresses. The idea is to prevent immune cells that damage the pancreas while the body still produces beta cells.

Groups around the world are bringing different ideas and creative approaches to treat type 1 diabetes, thats the beauty of science, says Nostro. I am very hopeful about what the future holds. Who knows? Maybe we will see hybrid technologies combining a pump and cells. We have to keep an open mind.

This story was originally published in U of T Med Magazines Insulin Issue.

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Insulin 100: How the road to a diabetes cure is yielding better treatments - News@UofT

Boxcar scars are a type of acne scars which look like round, oval depression. As the scars are of different types, for example, based on redness, depth or location, its treatment also varies. Microdermabrasion, Dermabrasion, Fillers, Chemical Peels, Laser Therapy, Microneedling, Punch Excision, and Subcision, are some of the treatments required for treating boxcar scars. As these scars cant go away of their own, People considering the treatment is growing.

Growing Preference for Micro needling and Ablative Lasers

The ablative lasers are considered as the gold standard for treating acne scars, patients have witnessed a 75% improvement in atrophic acne scars at 18 months after this high energy carbon dioxide laser treatment. The technique when used on dark skinned people showed good to excellent results in 74%, however hyper pigmentation was witnessed among 29% of patients. Due to its long time recovery process and various side effects, the ablative lasers have become less popular.

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Of late, microneedling is gaining momentum as they provide the best cosmetic outcomes. Due to its collagen inducing effect, the encouraging results prove that microneedling is an effective and inexpensive method for dealing with boxcar scars. It takes very less time for recovering, a study found that only after 3 treatments, patients can visibly see the positive effect in their scarring and is relatively risk free. Microneedling can be performed with a dermaroller or a microneedling pen. Microneedling involves puncturing the skin multiple times using needles, a tattoo gun or roller. When microneedling is combined with platelet rich plasma or glycolic acid peels, improvement in acne scar improved up to 62%.

Emerging Technologies Can Boost Adoption of Boxcar Scar Treatment

Researchers and scientists are always on the motion of developing and introducing new and more effective treatments for replacing the traditional therapies. For instance, a latest technology for the treatment of scarring is laser speckle contrast imaging (LSCI). LSCI helps in detecting the backscatter which eventually detects the blood flow by illuminating the tissue with its coherent laser light. The technique is relevant for scarring because the healing process of scarring requires adequate tissue perfusion. LSCI can also be used to treat patients with burn wounds as it detects the severity of partial thickness in wounds.

Complications in Laser Therapy

Side effects due to laser therapy such as burns, dyspigmentation and infection may happen after the laser treatment. Laser treatment has a risk of overheating the tissue through excessive heat generation or by a failure of the cooling techniques. The risk of burns is higher for lasers that use a continuous beam. Risk of dyspigmentation is higher in dark skinned or tan individuals. Due to such side effects, the treatment by laser may go back scale. However, latest innovations in the sector may help in mitigating the issue.

Competitive Landscape

The key players in the market include Merz, Inc., Cerave, Lumenis, Enaltus LLC, Scarsheal, Inc., CCA Industries, Proactiv Company, Cynosure, Inc., PCA Skin, Solta Medical, Smith and Nephew plc, Scarheal, Inc., NewMedical Technology, Inc., Bausch Health, Suneva Medical, Inc., Sonoma Pharmaceuticals, Inc., etc.

Latest development by doi.org shows 755nm picosecond Alexandrite laser has been effective in patients with acne scars. In the split face study, people were treated with laser in half of their face and that half showed effective improvement results in Post inflammatory erythema and acne scars. Patients stated that treatment was tolerable, with only mild erythema discovered as a side effect.

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A study reported in the Journal of cosmetic dermatology in February 2020 by Darrow Stem Cell Institute demonstrated that platelet rich plasma shows better response, fewer side effects, and shorter downtime as compared to combined subcision and PRP. The experiment was performed on 45 patients with atrophic acne scars by dividing the group into 3 and giving intradermal injection to first group, chemical reconstruction of skin scars was performed on second group and combined skin needling and PRP was performed on the third group. The third group witness significant improvement without any major side effect thus, reaching to the conclusion that PRP is beneficial for acne scars.

PICOCARE 450 is a US FDA approved machine developed by WonTech for laser skin care treatment. The innovative machine is responsible for treating all skin types, show faster visible results in less sitting. The technology targets only the pigment to be removed and is suitable for treating chickenpox scars, ice pink scars, boxcar scars, acne scars, etc.

Regional Outlook

According to WHO, scars affect almost 80-90% of teenagers in the western world. As per the study by National Library of Medicine, boxcar scars are prevalent and is almost in 54% population as post acne scar. Thus, rising incidences of burn cases and also increasing prevalence of boxcar scar cases is expected to drive the market during the forecast period. According to the survey by Harris Poll around 10 million patients who have had dermal filler have experienced filler treatment a good option, thus, its demand is also one of the factor for the boost of boxcar scar market.

Asia Pacific is also leading market for the boxcar scar treatment. Due to increased incidences of burns in India having a record of 70lakh burn injury cases every year, the adoption of treatment is also expected to surge. Rising awareness about the treatment of scars is yet another factor boosting the growth. Japan in Asian region is an ideal market due to availability of various treatment options owing to the increase in health care expenditure.

UK is a major contributor to the European market. According to British Association of Plastic, rising number of plastic surgery units in UK is fuelling the adoption of large number of incidences. Microneedling as a treatment is escalating in Europe owing to its benefits for skin tightening, better skin texture, scar reduction, improved skin tone, etc. Moreover, growing adoption of anti-ageing procedures, and awareness regarding the treatments is escalating the market further.

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Segmentation

By Treatment Type

By Laser Product

By End-user

By Region

Key Questions Answered

Carbon dioxide and Pulse dyed laser are some of the laser products used for boxcar scar treatment

Proactiv Company, Cynosure, Inc., PCA Skin, Solta Medical, Smith and Nephew plc, Scarheal, Inc., NewMedical Technology, Inc., Bausch Health, etc.

Latest innovations, growing awareness regarding the treatment, and comfortable treatment is giving people the confidence to treat.

US, UK, France, Germany and Italy are some of the largest markets for boxcar scars

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Boxcar Scars Market |Exclusive Report on Latest Trends and Market Growth Opportunities - BioSpace

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that the European label for KEYTRUDA, Mercks anti-PD-1 therapy, be updated to include data from KEYNOTE-361, a Phase 3, open-label trial that evaluated KEYTRUDA as a monotherapy and in combination with chemotherapy for the first-line treatment of certain patients with advanced or metastatic urothelial carcinoma. In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) 10. This approval was based on a single-arm study, KEYNOTE-052; KEYNOTE-361 was conducted as part of a post-marketing commitment following the initial approval of KEYTRUDA for these patients.

As previously announced, KEYNOTE-361 did not meet its primary endpoints of progression-free survival (PFS) and overall survival (OS) for the combination of KEYTRUDA plus chemotherapy. However, the CHMP concluded that the benefit-risk profile remains positive and that including data from KEYNOTE-361 in the label allows physicians to evaluate the potential benefit-risk of KEYTRUDA on an individual basis.

KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. We are pleased with todays positive opinion by the CHMP, which fulfills our post-marketing requirement for KEYTRUDA in these patients in the European Union and will enable continued access for patients in need of another treatment option.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

Link:
Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult...

NEW YORK, March 31, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). Plinabulin in combination with a G-CSF therapy, which received breakthrough therapy designation from the U.S. FDA and the China NMPA for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of CIN, has the potential to raise the standard of care in CIN for the first time in 30 years.

CIN remains a severely unmet medical need. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the neutropenia vulnerability gap where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first agent seeking FDA approval that has the potential to fill this gap by working in Week 1 to prevent the onset and progression of CIN. Therefore, combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study.

CIN is a major concern for physicians and their patients undergoing cancer treatment. Plinabulin provides benefits above and beyond what is currently available on the market and has the potential to be a game-changer for patients undergoing chemotherapy treatment, said Dr. Douglas Blayney, Professor of Medicine at Stanford University Medical School and global PI for CIN studies. CIN, which can lead to life-threatening infections, is the number one reason for the 4Ds in chemotherapy (Decrease, Delay and Discontinue dose and Downgrade regimen). We hope plinabulin will allow patients to better tolerate chemotherapy, thus enabling patients to stick to their optimal treatment plan and avoid serious CIN complications.

The NDA submission is based on positive data from BeyondSprings PROTECTIVE-2 Phase 3 registration study which showed that plinabulin in combination with pegfilgrastim demonstrated superior CIN prevention benefit, compared to pegfilgrastim alone. The study met the primary endpoint, with a statistically significant improvement in the rate of prevention of grade 4 neutropenia (improved from 13.6% to 31.5%, p=0.0015) and met all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir. In addition, the combination reduced clinical complications such as incidence and severity of febrile neutropenia (FN) and incidence and duration of hospitalization for FN patients. The combination is well tolerated, with an over 20% reduction of grade 4 Treatment-Emergent Adverse Events (TEAE) in the combination compared to that of pegfilgrastim alone. The NDA submissions will include five supportive trials that show consistent CIN prevention in various chemotherapy regimens and cancers in over 1,200 patients.

This NDA submission is the culmination of years of research to prove that plinabulin can improve the long-established standard of care and address an unmet medical need to further alleviate the risk burden of CIN for patients receiving chemotherapy, said Dr. Lan Huang, co-founder, CEO, and chairman of BeyondSpring. With CIN responsible for potentially delaying treatment and causing life-threatening infections, we hope that receiving the improved care represented by the plinabulin and G-CSF combination will allow patients to better tolerate chemotherapy and potentially see increased treatment success rates. We are grateful for the patients participation in plinabulins clinical trials and the participation and contributions of our investigators and our many other clinical partners.

Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or FN), which necessitates ER/hospital visits. Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >20%), to include intermediate-risk patients (FN rate between 10-20%), to reduce the number of hospital/ER visits related to CIN. The revision of the NCCN guidelines effectively increases the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually.

There is a large unmet medical need and a growing market for CIN prevention and treatment in China as well. According to Lancet Oncology, 60% of East Asia cancer patients are treated with chemotherapy1. In 2020, there were 4.6 million new cancer patients in China which could correspond to 2.8 million patients using chemotherapy and needing CIN prevention agents. According to IQVIA data, the G-CSF drug market (for CIN treatment) in China is growing at over 30% a year.

About PROTECTIVE-2 (Study 106) Phase 3 Registration Study The Phase 3 portion of PROTECTIVE-2 was a double-blind and active-controlled global registration study. It was designed as a superiority study to compare the safety and efficacy of plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose) in patients with breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle. TAC is an example of high FN risk chemotherapy and is the regimen used in all G-CSF biosimilar registration studies.

The primary endpoint was the rate of prevention of Grade 4 neutropenia and secondary endpoints included DSN and mean ANC nadir in Cycle 1. Literature shows that despite the use of pegfilgrastim, 83 to 93 percent of patients treated with TAC still suffer Grade 4 neutropenia (or rate of Grade 4 neutropenia prevention at 7-17%), which demonstrates the severe unmet medical need for improved treatment2,3.

The ANC data, which are used to calculate these endpoints, were obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests. Covance was the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study.

About CINChemotherapy-induced neutropenia (CIN) is the primary dose-limiting toxicity in cancer patients who receive chemotherapy and is the primary cause for the 4Ds (Decrease, Delay, Discontinue dose and Downgrade regimen). The 4Ds lead to a decrease of the anti-cancer benefit of chemotherapy, e.g., >15% of dose reduction correlated to >50% survival reduction4. The National Comprehensive Cancer Network (NCCN) recently updated its treatment guidelines for CIN prophylaxis using G-CSFs to include both high- and intermediate-FN risk patients treated with chemotherapies, to preserve hospital and ER resources for COVID-19 patients, and to maximize protection from CIN. The NCCNs action effectively doubled the number of patients recommended to receive CIN prophylaxis.

About PlinabulinPlinabulin, BeyondSprings lead asset, is a selective immune-modulating microtubule-binding agent (SIMBA). A global Phase 3 clinical trial in CIN (PROTECTIVE-2) with plinabulin in combination with pegfilgrastim versus pegfilgrastim alone has been completed and is the basis for an NDA filing in the U.S. and China for the prevention of CIN. In this trial, plinabulin reduced the neutropenia vulnerability gap associated with G-CSF therapy alone. Additionally, a global Phase 3 study for the treatment of later-stage NSCLC in EGFR wild-type patients (DUBLIN-3) is now fully enrolled and will evaluate the combination of plinabulin and docetaxel versus docetaxel alone for overall survival in NSCLC patients. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells5,6 and the second is early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs)7. Effects on HSPCs could explain the potential for plinabulin not only to prevent CIN but also to increase circulating CD34+ cells in patients. As a pipeline in a drug, plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1 / PD-L1 antibodies.

About BeyondSpringHeadquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSprings first-in-class lead asset plinabulin is a pipeline in a drug. It is filed for approval in the US and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology agents that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSprings extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

References:

Investor Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 617-430-7577arr@lifesciadvisors.com

Media Contact:Darren Opland, Ph.D.LifeSci Communications+1 646-627-8387darren@lifescicomms.com

See more here:
BeyondSpring Announces Submission of New Drug Application to US FDA and China NMPA for Plinabulin and G-CSF Combination for the Prevention of...

Its something of the holy grailrun whole genome sequencing on a sample of a persons blood and identify their risk for disease, all quickly and affordably. Oxford, Englands Genomics, founded in 2014 out of Oxford University by Sir Peter Donnelly, may be getting close.

The company is launching a trial in a new NHS pilot project with 1,000 volunteers, focusing on heart disease. It also plans to begin a similar trial in Stanford Hospitals in California with about 5,000 patients between the ages of 40 and 60 starting this summer.

If effective, it would be able to help people in their 40s or 50s determine the likelihood of their developing heart disease. This would allow physicians to help patients make the appropriate lifestyle changes and begin taking necessary drugs, such as statins.

The volunteers in the studies will donate a blood sample and the Genomics technology platform leverages an algorithm to analyze their genetic patterns. Some of those patterns have been associated with an increased risk of heart attack later in life, even if they currently have no symptoms. They will then be given a personal polygenic risk score (PRS), which can be used alongside a clinical risk prediction tool that the NHS is already using, that takes into consideration things like BMI and cholesterol levels.

This is yet another example of the NHS leading the world with this trial, Donnelly told the Evening Standard. This is cutting edge [tech]. It is about getting it into healthcare now and increasing focus on prevention.

Although these studies are focusing on heart disease, the companys technology is also focused on a range of genetic patterns associated with other diseases, such as cancer and multiple sclerosis. Donnelly even thinks its possible that eventually it will be used to evaluate people in their 20s and 30s for diseases that are more commonly developed earlier, such as auto-immune diseases.

Of course, some people may not want to know.

I understand why someone would be a bit worried, Donnelly said. It is important to say that these are just risk factors. If you have a high PRS score for heart disease, you are around four to five times more likely to get it. Its not that genetics determine the outcome, it is a risk factor. In all cases, there are things you can do [to help prevent disease]. You can be more vigilant, you can have medical interventions. That is important to understand.

On March 1, Genomics completed a $30 million funding round, with investments from Foresite Capital and F-Prime Capital, joined by existing backers Oxford Sciences Innovation and Lansdowne Partners. The company plans to use the monies to expand its work building its health platform.

Jim Tananbaum, chief executive officer of Foresite Capital, stated, Genomics plc plays a key role in transforming how we understand and deliver precision medicine at scale. We are excited to support this talented management team as the company embarks on its next growth phase.

Stephen Knight, president and managing partner of F-Prime Capital, noted, The convergence of data sciences with life sciences is one of the most exciting areas in healthcare today and we see Genomics plc as a clear leader in that field. The companys proprietary research platform powered by a large dataset of genotypic and phenotypic information, combined with the leading statistical genomics team in the world, delivers unique insights in the discovery of new therapeutic targets as well as key advancements in preventative healthcare.

Read more here:
Oxford's Genomics Pushing the Boundaries of Personalized Medicine - BioSpace

Master Sgt. Geoff Dardia was nearly a decade into his Special Forces career when he says he hit a wall. He was struggling both mentally and physically to keep doing his job and couldnt explain why.

All of the sudden, I was just a shell of a person like everything you hear about feeling like youre dragging a dead body and losing your zest for life, Dardia said.

Plagued by severe migraines, fatigue and issues with his balance and vision, Dardia, now 44, sought help.

His superiors told him to visit a military behavioral health specialist and be treated for PTSD or depression, but Dardia was convinced his ailments were more than just psychological. So, he did what any good Green Beret would do and applied his training to research, analyze and attack the problem condition.

Following the steps of the military decision-making process, Dardia learned everything he could about his operational environment and the various ways it could affect him.

Traumatic brain injuries, toxic exposure to heavy metals and carcinogens, traumatic stress and sleep deprivation are unfortunately common occurrences for members of the special operations community.

After identifying the underlying causes for his symptoms, Dardia began planning a course of responsive action. The process was so simple, straightforward, and guided by existing military doctrine that it led him to question the Armys current approach to health care.

I was like, This is so easy. Why wouldnt we do this with health and wellness and medicine? Dardia said.

The Early Bird Brief is a daily roundup of military and defense news stories from around the globe curated by Military Times and Defense News.

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At its core, thats what functional medicine is all about: finding and treating underlying causes of illness or pain. The Institute for Functional Medicine defines it as a systems biology-based approach that focuses on identifying and addressing the root cause of disease.

Also referred to as personalized, performance or lifestyle medicine, the approach is grounded in a philosophy of caring for a whole person made up of interconnected parts.

Its what Dardia and health care professionals spoke about on March 25 at the Warfighter Health Symposium in Tampa, Florida. Hosted by non-profits Task Force Dagger Special Operations Foundation and HunterSeven, the event served to informally educate active duty servicemembers, medical providers and veterans about the current issues and solutions in military health care. There were 50 people the maximum allowed under COVID-19 restrictions who attended.

After personally experiencing the difficulty of receiving holistic treatment, Dardia began making the changes he wanted to see. In 2012, when TFDSOF helped him through his personal health struggles, Dardia decided to give back by founding the organizations Health Initiative Program.

The program provides pathways and funding assistance for members of the military to seek treatment from outside health care providers and institutions in the field of personalized medicine.

Partnering with organizations like the Cleveland Clinic Center for Functional Medicine and becoming involved with active-duty health initiatives in the 3rd Special Forces Group, Dardia has been raising awareness of the power of preventative and holistic medicine for the better part of a decade now.

According to Dardia, the militarys current approach to health care is too reactive. Service members are treated for cancer or suicidal ideations or organ failures when such issues could have been prevented with proper countermeasures and education about their causes years earlier.

Just because you have mental health symptoms, doesnt mean mental illness is the cause, said Dr. Carrie Elk, founder of the Elk Institute for Psychological Health & Performance, a non-profit established to provide mental health education and treatment to servicemembers.

Elk has worked with SOCOM and the SOF community to treat operators for the underlying cause of post-traumatic stress disorder since 2010, when she first spoke at the Joint Special Operations Forces Senior Enlisted Academy on how PTSD works. Her practice now reaches both operators and members of the general military community.

They were applying the same stuff they used for mental illness to PTSD, but the problem is just the way the information is stored, said Elk. The audience was stunned by Elks presentation, and special operations personnel began filling the waiting room of her practice.

In just two hours of therapy, the doctor says, shes able to correct the storage of a traumatic memory.

In traumatic situations, according to Elk, memories are stored as sensory experiences. When servicemembers return home from traumatic environments, triggers like smells and sounds can bring them right back to places of anger, agitation, depression and anxiety.

Health care providers treating symptoms of depression and anxiety with prescription medications ignore the real problems at hand, according to Elk.

Were putting a Band-Aid on a bullet hole or at least trying to, said Elk. Youre not fixing the cause, youre just managing symptoms when you dont have to.

Functional approaches like Elks are growing in popularity. The Army adopted a section on holistic health in its updated physical fitness doctrine in September 2020 a combination of its previous initiatives like the Performance Triad and Army Wellness Centers.

The Holistic Health and Fitness program, or H2F, is the framework to encompass all aspects of human performance to include physical, sleep, nutritional, spiritual, and mental fitness, said Maj. Gen. Lonnie G. Hibbard, commander of the U.S. Army Center for Initial Military Training in a press release.

The Department of Veterans Affairs has introduced similar programming aimed at addressing the causes of illness rather than symptoms.

The biggest thing is awareness and education and advocacy, said Dardia. The earlier servicemembers can learn to prevent toxic exposure and recover from stress and sleep deprivation, the healthier theyll be in the long term.

Now the operations sergeant for 3SFGs Human Performance and Wellness program and the Medical Education Transition Advocacy and Assistance program, Dardia is focused on bringing personalized medicine programming to other Special Forces groups, veterans and units across the military.

At Thursdays symposium, Dardia spoke on functional, performance medicine alongside health care professionals from the HunterSeven Foundation.

Members of SOCOMs medical staff attended the three-hour conference in personal capacity, but SOCOM did not officially participate, according to a spokesperson.

Our main focus is research and education, given that we are medical experts with advanced clinical licenses and degrees, said Chelsea Poisson, an Army veteran, emergency nurse and clinical researcher with HunterSeven. The attendees were extremely receptive, I had many questions from members across all communities on resources and what to do next.

In addition to working with members of Congress to give suggestions and solutions to military health care legislature, HunterSeven provides TFDSOF with access to its extensive research on veterans health care issues.

HunterSeven is working on legislation and research to get laws passed that provide our people with better access to health care quicker, said Dardia. Theyre optimizing systems already in place, whether thats in the DoD or at the VA.

As functional, lifestyle-based medicine is adopted across the military, Dardia hopes to work himself out of a job. In years to come, the Green Beret hopes to begin correcting the problem of reactive health care in the civilian population, educating young people about disease prevention and holistic medicine.

We want to advocate this not just for military personnel and veterans; this applies to everybody, said Dardia. This isnt unique to the military. Cancer and suicide are rampant in the civilian population as well, and for the same reasons.

More here:
Personalized medicine is the future of health care for troops, advocates say - Military Times

Precigen Chief Executive Officer Helen Sabzevari pictured above.

The year 2020 and the COVID-19 pandemic created a number of challenges for individuals and companies. Despitethese hurdles, Maryland-based Precigen still managed to achieve its clinical milestones in oncology.

The company is advancing its UltraCAR-T cell therapy approach to treating cancer that Chief Executive Officer Helen Sabzevari believes will be transformative to the personalized cell therapy landscape for cancer patients.

This is what precision medicine in the twenty-first century should look like, Sabzevari told BioSpace in an interview.

Sabzevari joined Precigen in 2017after undergoing a rebranding effort that included a name change from Intrexon Corporation, as well as the divestiture of non-healthcare assets, such as AgBiotech and Intrexon Produce Holdings. The company now focuses on the development of next-generation gene and cell therapies that have potential to change the treatment paradigm in immuno-oncology, autoimmune disorders and infectious diseases.

While there are multiple companies pursuing programs of these types, Sabzevari said Precigen can differentiate itself through a unique precision medicine approach that could simultaneously impact different types of genetic expressions on cancer cells, both hematological and solid tumors. Additionally, Precigen believes its UltraCAR-T immunotherapies can be developed with fewer toxicity issues and manufactured at a lower cost than currently available CAR-T treatments.

She added the company has the most differentiated platform in cell and gene therapy compared to other companies in the space.

The company is developing two UltraCAR-T platforms. The first, PRGN-3005 UltraCAR-T, is a first-in-class investigational therapy currently being assessed in a Phase I/Ibclinical study for the treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer.

In December, Precigen reported preliminary data from the study that showed a favorable safety profile with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine release syndromes. What may be most important of all, Sabzevari said the study showed the UltraCAR-T treatment generated expansion and persistence after low dose IP infusion without lymphodepletion.

Precigen intends to begin a dose expansion of this study in the second half of the year. For the first time, Sabzevari said, they were able to show clinical efficacy in a solid tumor. Approximately 50% of patients showed a decrease in tumor lesions.

Precigen is also developing PRGN-3006 UltraCAR-T, a first-in-class investigational therapy currently under clinical evaluation in a Phase I/Ibstudyfor the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS).

Preliminary Phase I data reported in December showed a favorable safety profile with no DLTs or neurotoxicity. Encouraging expansion and persistence of PRGN-3006 UltraCAR-T was observed in both lymphodepletion and non-lymphodepletion cohorts and across all dose levels. PRGN-3006 treatment indicated clinical activity as evidenced by reduction in AML tumor blast levels, the company said. Data from the PRGN-3006 study also revealed that UltraCAR-T cells persisted for more than seven months after a very low dose of 24 million total UltraCAR-T cells in a patient. Sabzevari said this highlights the difference between Precigens UltraCAR-Ts and other CAR-T programs, which introduce hundreds of millions of CARs in to patients during an infusion. Those CARs also have a shorter life than the Precigen assets, which means they can have a sustainable impact on cancer.

Following the revelation of the preliminary data, the U.S. Food and Drug Administration awarded PRGN-3006 with Orphan Drug Designation for AML.

While CAR-T therapies are not yet considered front-line defenses in cancer, Sabzevari predicted that cell and gene therapies will eventually move to first-line options.

Checkpoint inhibitors have become frontline therapies and thats the vision for CAR-T and cell therapies, she said.

Sabzevari likened the possibilities of Precigens UltraCAR-T therapies to antibiotics. If a doctor prescribes one and it does not produce the desired therapeutic effect, there will be another type available from the companys library that could treat the cancer.

If one target, for whatever reason isnt sufficient, you can switch overnight to change it with another. In our vision, a patient can come in and an oncologist could identify the indication of the cancer through screening, order a treatment from our UltraCar-T library and get it done, infuse the patient, Sabzevari said.

Because of the potential Precigens UltraCAR-T program has in oncology, Sabzevari believes the companys stock is significantly undervalued. In January, Precigenraised about $130 million. She believes the stock could go much higher and noted that Precigens market cap has tripled in the past year.

2021 promises to be another transformative year for our company with important data readouts and trial initiations anticipated for our key programs. We have a very good stretch of growth in front of us, Sabzevari said.

Excerpt from:
Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy - BioSpace

According to P&S Intelligence, the precision medicine market generated $203.5 billion in 2019 and it is expected to reach $738.8 billion by 2030, progressing at a CAGR of 12.1% during the forecast period (20202030). This growth can be driven by the rising government support, escalating awareness regarding personalized treatments, rising number of approved personalized medications, increasing use of artificial intelligence (AI) in clinical trials related to precision medications, surging number of regulatory approvals, soaring cases of chronic and genetic diseases, and flourishing medical tourism industry.

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Governments across the globe are taking several initiatives to develop personalized treatment, thereby, playing a vital role in the precision medicine market growth. According to the World Economic Forum, Argentina introduced a Precision Medicine Initiative Grant, in 2017, to start the scientific procedures needed to introduce investigational precision medicine approaches into clinical practices. Similarly, the U.S. administration under its Personalized Medicine Coalition announced its plan, in July 2019, to bring down the costs of drugs in the country, to make them comparable with international rates.

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Globally, the North America held the largest share in 2019, and it is expected to continue its dominance during the forecast period. This is due to the rising incidence of lifestyle-associated and chronic diseases, like CVDs and diabetes, burgeoning healthcare spending, and increasing number of government initiatives in the form of awareness programs and funding for precision medicine. Whereas, the Asia-Pacific (APAC) market will register the highest growth in the forecast years, owing to the increasing healthcare expenditure, presence of players developing precision medicines, and growing awareness about these medicines.

Thus, the rising frequency of critical trials and the magnifying government support will propel the market growth in the coming years.

This study covers

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What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier - The Courier

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Global Nanomaterials in Personalized Medicine Market 2021 by Manufacturers, Regions, Type and Application, Forecast to 2026 The Bisouv Network - The...

The COVID-19 pandemic has spawned collaborations in the Denver medical community that could help usher in a new golden age of medicine.

As the medical director of the Medical Intensive Care Unit at Denver Health, Dr. Ivor Douglas knows better than most how devastating a toll COVID-19 has taken. Weve lost 400,000 people, which is as many Americans as were lost in the Second World War, he says. (The number topped 520,000 in early March.) And weve done it in a year.

At the same time, Douglas understands that the unwelcome arrival of the novel coronavirus presents an opportunity to advance health care at an unprecedented rate. Absolutely its going to have long-term effects on human health and scientific discovery, Douglas says. He believes such rapid progress will occur because, well, hes seen it happen.

For about 20 years, Denver Health has been treating acute respiratory distress syndrome (ARDS)when fluid builds up in the tiny air sacs in the lungs, limiting the air they can holdby rotating ventilated patients from lying on their backs to the prone position, on their stomachs, for prolonged periods of time. Although the practice seems counterintuitive (doesnt breathing on your stomach appear constrictive?), Denver Health and other hospitals believed the practice increased oxygen levels while decreasing ventilator-induced lung injuries. But because there hadnt been a consensus on the effectiveness of the procedure, and its cumbersome to move intubated patients from supine to prone (three to six people are required), few hospitals regularly performed the technique.

Then COVID-19 began causing ARDS in severe cases. A number of studies promptly affirmed that proning such patients was a potentially life-saving decision. Further, research co-authored by Douglas lent credence to the safety of prolonged proning, in which patients remain in the position for days at a timemore than 20 in some cases. Once the pandemic is over, doctors around the world will use that information to treat people suffering from ARDS caused by bacterial pneumonia or viral influenza.

Similar COVID-19-spawned symbioses are not rare in Colorado. Rival health systems have banded together; thousands of patients have donated their DNA to scientific research; and specialists have rebuilt relationships with community doctors. While the trauma of COVID-19 will endure for years, its lessons could inspire benefits that last for generations.

When confusion reigned, Colorados largest health care providers united to chart a course through the pandemic.

When COVID-19 first arrived in the United States, the Centers for Disease Control and Prevention advised that Americans who werent sick didnt need to wear masks. Back then, even experts didnt understand the best ways to combat the disease. No one knew what was going on, says Dr. JP Valin, chief clinical officer at SCL Health, and that includes the health care providers of Colorados seven largest hospital networks. So we just said, Lets work on this together, Valin says. Physician executives of SCL Health, UCHealth, HealthOne, Centura Health, Denver Health, Boulder Community Health, and Banner Health began meeting virtually every weekday (and some weekends) to share data, discuss best practices, and manage the local distribution of personal protective equipment. By the end of July, the networks had collaboratively cared for 98 percent of the COVID-19-related hospitalizations in Colorado, and according to a study about the partnership published in the New England Journal of Medicine Catalyst, they boasted lower mortality, lengths of stay, and mechanical ventilation rates than the national averages. The collaboration later became a model for other states. We cant lose this after the fact, Valin says. This is something special, and weve done some really cool things.

How the rival networks worked together to ensure Coloradans got the care they needed during COVID-19.Back to Top

Perspective: Before the state instituted a COVID-19 tracking system, the partnership recognized early outbreaks. In March and April 2020, Banner began seeing a spike in positive tests in Weld County. When UCHealths hospitals in Weld reported a similar flare-up, they traced the surge to patients employer: the JBS USA Greeley beef plant. The group notified the state and county, which closed the plant (although a Denver Post story questioned the speed with which Weld responded).

Patient advocacy: Many hospitals and clinics in rural areas are affiliated with a larger providerbut some are not, and more than 60 percent of U.S. rural hospitals dont have a single ICU bed. So the collaborative worked through the Colorado Hospital Association to set up partnerships between rural hospitals and larger ones. The relationships included dispensing advice and accepting patients if they required emergency care. In 48 hours, Valin says, we were able to quell a lot of unease in rural areas.

Partnership: When hospitals were allowed to perform elective surgeries again in late April, SCL Health developed an algorithm to assess the health of incoming patients, and it shared this with the other systems. So every patient in the state of Colorado who was getting an elective procedure followed that exact same protocol, Valin says, rather than patients and doctors being confused [about precautions], or one hospital being safer than another. We wanted there to be confidence in all of us.

Peer support: An unexpected benefit of the partnership was the partnership itself. Physician executives are often isolated from their peers (both from other doctors and other C-suite suits). Through working with execs at other systems, they enjoyed support, workforce development ideas, and, in late August, a happy hour. We went to the Lowry Beer Garden, where its all these picnic tables, Valin says. There was a lot of trust generated very quickly because we could say, Were doing the right thing.

Childrens Hospital Colorados virtual town halls became a must-listen for a pediatric community that needed healing.Back to Top

For most of Childrens Hospital Colorados 113 years, community doctors tended to the facilitys patients. But as the economics of medicine changed, fewer physicians could afford to leave their practices to spend time at the hospital. Specialists became primary caregivers for inpatients. As a result, says Dr. David Brumbaugh, chief medical officer of Childrens, the hospitals relationship with the local pediatric community grew distant. Then COVID-19 struck. To help terrified local doctors who needed concrete answers, Childrens began hosting virtual town halls. Eventually, about 500 providers began tuning in on Thursday nights to listen to Childrens docs review the latest science. The fringe benefit: The town halls began to rebuild the connection between the hospital and community providers. We spoke with some of Childrens most avid weekly audience members to hear how.

Dr. David Brooks | Valley View Hospital, Glenwood SpringsWe reached out to Dr. Sean OLeary [a pediatric infectious disease specialist at Childrens] and he presented a Zoom conference [on virtual learning] to about 200 people in the Roaring Fork Valley. After that, pediatricians here helped re-establish in-person learning. Im not sure we would have progressed to that point without the town halls.

Dr. Sharisse Arnold Rehring | Kaiser Permanente, DenverI think I personally received several face shields from Childrens in the mail because I didnt have any, and I wasnt sure we were going to get them at Kaiser Permanente. We did, but Childrens Hospital didnt ask any questions except, Whats your address?

Dr. Sharon Sagel | Southeast Denver PediatricsAt the beginning you felt like this very small fish in this really big pond. How do we practice? We felt like we were reinventing the wheel every day. And then all of a sudden youre connected to a whole community of pediatricians who are all in the same situation. I dont know what the future will look like, but I think there is this sense that were all better when we work together.

Dr. Matt Dorighi | Cherry Creek PediatricsThese town halls have certainly created the environment where you have that confidence to do new things, like telehealth. Its such a great format for getting information on new ideas. Itll be interesting to see what topics they shift to after the pandemic. But its been a really efficient way to affect change in the community.

Thanks to the telehealth boom, UCHealths Biobank connected with more patients than ever.Back to Top

Personalized medicinealso called precision or individualized medicinetailors treatment to the specific indicators locked away in our unique DNA (and other molecules). The discipline could help improve the outcomes of pharmacology and even predict future diseases, such as breast cancer, based on cellular variances. In order for personalized medicine to work, however, it needs data. Lots of data. The more DNA collected, the more connections that can be made. The University of Colorado Anschutz Medical Campus Colorado Center for Personalized Medicine launched its Biobank in 2016 to become the repository of such info for UCHealth. It has since signed up more than 173,000 patientsbut owes its biggest surge in outreach to COVID-19.

Biobank asks UCHealth patients to participate through the systems online patient portal, My Health Connection. Before the pandemic, though, fewer than half of the networks patients used the portal to, say, schedule appointments. When the pandemic forced UCHealth to switch primarily to telehealth visits, patients were suddenly required to use their portalsand, thus, interact with the Biobank consent form. Weve actually been able to reach out to more potential volunteers for the Biobank than we ever could have done before, says Kathleen Barnes, director of the center. Which means a global pandemic could play a part in helping make Coloradans healthier than theyve ever been before.

The pandemic has felt particularly isolating to new parents. Maybe thats not such a bad thing.Back to Top

In August 2020, three months before she was due, Aliesa Pope-Hodge gave birth to her second son, Reign, at the Medical Center of Aurora. Weighing one pound and eight ounces, Reign was immediately placed on a ventilation system that filled his underdeveloped lungs with about 360 breaths per minute. He looked like he was vibrating, Pope-Hodge says. She estimates she got to see Reign for 20 seconds before hospital staff ushered the baby into an ambulance for the 10-mile trip to Presbyterian/St. Lukes (PSL) Medical Centers newborn intensive care unit (NICU), a Denver facility qualified to serve the most acutely ill infants.

There, Pope-Hodge and her husband, Diamond Taylor, donned masks, scrubbed and washed their hands, and were screened for fevers every time they visited Reign. Neither family nor friends were allowed to join them. But the restrictions were nothing compared to Pope-Hodges own feelings of separation. While practicing skin-to-skin contact to encourage bonding between mother and child, Reign would often cry. His heart rate and oxygen levels would dropa common occurrence for preemies experiencing touch for the first timeand alarms would shriek. I felt scared to touch him, Pope-Hodge says. Like I was going to hurt him. Maybe I stress him out? I felt detached from Reign for a very long time.

Detachment might be the official emotion of the pandemicparticularly for new parents. Even though nascent research suggests COVID-19 is uncommon in newborns, even among those with COVID-19-positive mothers, most local hospitals and birthing centers have restricted access during birth to the parents (or mom and one support person, such as a doula). Once a baby heads home, many doctors recommend limiting visitation there as well.

While this has thwarted the ambitions of cheek-pinching grandparents, seclusion hasnt been all bad for parents. You arent trying to cater to extended family and keep them updated, says Dr. Anna Zimmermann, a neonatologist at PSLs Rocky Mountain Hospital for Children. It pares the experience down to the parents and allows them to just get to know their baby.

Research on the benefits of pandemic-induced alone time is minimal so far, but one study did test its impact on familial bonds. During April 2020, 70 pregnant women in Ireland participated in a survey that sought to quantify the emotional effects of social distancing. Of those whose relationships with their partners had not deteriorated (only three had), 34.3 percent said theyd grown closer, 28.4 percent said they talked more, and 20.9 reported exercising together.

Pope-Hodge and Taylor finally brought a five-pound Reign home from PSL in November and promptly barred visitorsa difficult decree considering they live with Taylors mother. She held him on Christmas, Pope-Hodge says. Other than that, she hasnt touched him, which is really hard for her. She feels stripped of the gift of being a grandmother.

The isolation, though, has allowed Pope-Hodge to form a connection with Reign that she never imagined possible at the NICU. [Our eldest son] King had his grandma and his aunties, and everyone else around him that gave him love, Pope-Hodge says. With Reign, I feel proud that I am, with Diamond, the ones who are taking care of him. Everything that he gets is from me. I feel really proud of that.

Confronting the connections between public health and health care in our local communities.Back to Top

More than any other disease, COVID-19 has drawn attention to the tether between social ills and physical illness. The pandemic has just brought it to the fore in ways that, frankly, diabetes didnt, kidney disease didnt, [and] high blood pressure didnt, says Dr. Jandel Allen-Davis, the president and CEO of Craig Hospital in Englewood. To illustrate the connection between COVID-19 and public health issues, Colorado Health Institute (CHI), a Denver-based public health advocacy group, created a Social Distancing Index (SDI). CHI gave each Colorado census tract a score from one to 10 based on its comparison to other tracts in the state in three areas: population density, overcrowded housing, and proportion of essential workers. The index is the average of a tracts three scores. The higher the score, the more vulnerable a tracts population is to the spread of COVID-19and, as noted below, a range of social inequities.

College ViewMore than 40 percent of children under 18 in College View live in poverty, compared to 18 percent countywide.

WestwoodThe four U.S. census tracts that make up the Westwood neighborhood are all at least 80 percent populated by people of color.

HilltopThe wealthiest tract in Denver County is in the Hilltop neighborhood (median household income: $209,000). It is 86.6 percent white.

MontbelloThis tract in the Montbello neighborhood is one of the 25 USDA-identified food deserts in Denver County, all but six of which have SDIs above the county median of 3.1.

East ColfaxAccording to the U.S. Department of Housing and Urban Development, the percentage of low- to moderate-income residents (those who earn less than 80 percent of the metro area median income) in this part of East Colfax ranges from 61.2 to 87.7 percent.

WindsorThe per capita income in this tract is $26,341, about three-fifths of Denver Countys per capita of $43,770.

Hampden SouthIn the tract with the lowest SDI, only 4.7 percent of residents live below the poverty line, compared to 12.9 percent across the county.

Bioethicist Matthew Wynia speaks out about the mortal dilemmas of the pandemicand how COVID-19 could forever guide our moral compass.Back to Top

Who gets a ventilator and who doesnt? Should everyone be forced to wear a mask? Which demographics deserve to receive the COVID-19 vaccine first? These are the questions the pandemic forced Dr. Matthew Wynia and other bioethicists to wrestle with as they attempted to guide the health care system through a stark market of supply and demand. Director of the University of Colorado Anschutz Medical Campus Center for Bioethics and Humanities, Wynia not only advised on state policy, but also helped oversee the UCHealth triage team as it made critical decisions. In the early stages of the vaccine rollout in Colorado, 5280 spoke with Wynia to better understand how local hospitals came to some very difficult decisions.

5280: Were the choices about, say, who would get ICU beds already determined before COVID-19 came along?Matthew Wynia: Not exactly. We had a framework because weve had prior pandemicsthe 2009 H1N1 influenza pandemic had generated a lot of interest in these issues. But it hadnt been adapted to COVID. So that was the initial work. Pull that off the shelf, open it up, and start making adjustments based on COVID. Very early on, we were already seeing that there might be a problem with blood clotting. Well, thats not a normal problem with influenza. How does that affect the clinical decision-making?

How does it?Those factors get put into your risk calculation for how likely a patient is to die if theyre really sick with COVID. Because if you think theyre going to die no matter what, youre better off not allocating them scarce resources. Also, if you think they might be able to pull through if they dont get the scarce resource, you similarly dont want to put them on the scarce resource.

So if a patient has a history of blood clots, no ICU?Well, Id be careful about that, because there are about 30 things in our calculation.

This is a question typically reserved for supervillains, but how did you sleep at night?I am famous in my family for being able to sleep anytime, anywhere. Thats my superpower. In March, for the first time in my life, I was tossing and turning, because we thought Colorado was going to get hit hard, and we were going to end up implementing our triage teams. The thing [we] do not want is the bedside doctor to be the one deciding who receives these resources and who doesnt. Number one, your bedside doctor should be your advocate. And number two, the bedside doctor does not have great situational awareness of what else is going on around the hospital or the region.

Yeah, but that means you have to make that decision.Yes, but based on better information than that individual doctor has.

Because of all the tough choices doctors had to make during the pandemic, do you think bioethics has evolved?If we make good decisions that clearly prioritize equity, we could come out of this with greater levels of trust in the health care system among racial and ethnic minority populations that havent always trusted the health care systembecause they didnt have a lot of good reasons to trust the health care system. Watching leaders in health care really struggle with how to do this right, so that we dont disadvantage this community, that can be a cohesion-building experience.

Spencer Campbell writes features and edits service packages.

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How COVID-19 Will Help Denver Doctors Revolutionize Health Care - 5280 | The Denver Magazine

OXFORD, England--(BUSINESS WIRE)--New research published this month in Frontiers in Medicine (Gastroenterology) reveals that individuals with both obesity and severe fatty liver are five times more likely to require hospitalization for the illness. The non-invasive liver imaging technology Perspectums LiverMultiScan was used to gather MRI scans for the study.

Obesity is often associated with fat accumulation in the liver, which can lead to liver disease, and emerging data suggests that patients with obesity are at an increased risk of becoming seriously ill with COVID-19. The World Obesity Federation summarizes recent reports suggesting in the US almost 50 percent of people hospitalized with COVID-19 were also affected by obesity. A new report from the CDC (Centers for Disease Control and Prevention, U.S.A.) indicates 78 percent of people who were hospitalized, placed on a ventilator or died from COVID-19 were overweight or obese.

The results of the imaging study, which explored whether having excess liver fat could influence severity of COVID-19 in obese individuals, showed that individuals with both obesity as well as fatty liver were five times more likely to require hospitalization for COVID-19. Notably, individuals with obesity and normal liver fat were not at increased risk of being hospitalized.

Some individuals with obesity have a normal level of liver fat and some non-obese individuals have high levels of liver fat. It is pertinent to establish whether pre-existing liver disease increases the risk of severe COVID-19 and how this relates to obesity, says Adriana Roca-Fernandez, first author and scientist at Perspectum, the company developing LiverMultiScan. Measurement of liver fat and detection of liver disease can be achieved using non-invasive imaging methods such as Perspectums well-validated, magnetic resonance imaging (MRI) technology to help identify patients with COVID-19 who are at increased risk of severe disease.

Understanding the contribution of liver fat to COVID-19 risk and outcomes is important for clinical understanding and management of COVID-19 and long COVID. The study, Hepatic Steatosis Rather Than Underlying Obesity Increases Risk of Infection and Hospitalization for COVID-19, Roca-Fernandez et al., 2021, also confirmed some previously reported risk factors for contracting COVID-19, such as being a male and having a lower socio-economic status. In addition, this study showed that the participants who had tested positive for COVID-19 were more likely to have higher liver fat. The MRI data were acquired before the COVID-19 pandemic by the UK Biobank, one of the largest biomedical databases in the world, and included 4,458 people who had later been tested for COVID-19.

According to Dr. Arun Sanyal, Virginia Commonwealth University, one of the authors of the study, The current study demonstrates pre-existing fatty liver disease is an independent risk factor for development of severe disease in those with COVID-19. This raises important questions about the role of hepatic steatosis and related liver injury as a disease modifying factor. These data highlight the public health relevance of NAFLD beyond cardiovascular, cancer and liver outcomes and provide a strong rationale for future studies to evaluate whether de-fatting the liver will reduce the likelihood of severe COVID-19 in affected individuals.

Determining all risk factors for increased severity of COVID-19 is crucial to help shape public policy measures to protect these high-risk individuals, such as social distancing, prioritization of people for vaccinations, and access to personalized medicine to guide clinical and lifestyle interventions, adds Roca- Fernandez.

Perspectum, a global medical technology company with offices in the U.K., the U.S. and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.

Excerpt from:
Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity - Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced the appointment of Brian Alexander, M.D., M.P.H., as chief executive officer, effective April 6, 2021. Dr. Alexander previously served as Foundation Medicines chief medical officer since 2019 and brings with him years of experience as a radiation oncologist at Dana-Farber/Brigham and Womens Cancer Center and an Associate Professor at Harvard Medical School. He succeeds Cindy Perettie, who has taken on a new role within Roche Diagnostics.

Brian has been instrumental in leading Foundation Medicine in its mission to rapidly advance personalized medicine for cancer patients on a global scale, said Severin Schwan, CEO, Roche Group. As an oncologist, he is uniquely positioned to help the company become an ever-more-essential partner for patients, physicians, and the researchers developing new cancer medicines by providing them with the insights they need to support critical decisions.

Dr. Alexander joined Foundation Medicine as senior vice president of clinical development in September 2018 and was promoted to Chief Medical Officer the following year. He has directed Foundation Medicines decision insights strategy to help more oncologists, both in community and academic settings, determine the right treatment, at the right time, for each unique patient. Under his leadership, Foundation Medicines medical team has expanded its molecular tumor board program to include over 90 leading oncology centers globally, launched a cross-functional genomics and health disparities effort, and has developed hundreds of studies and publications to advance the clinical utility of genomic profiling.

I am proud to be part of a team that has delivered groundbreaking innovations catalyzed by our unparalleled insights into cancer genomics, said Dr. Alexander. I am grateful to Cindy for her leadership and mentorship during such a transformative time for the company, and Im excited to lead the next chapter for this remarkable organization as we work to enable better therapeutic decision making and help our pharmaceutical and biotech partners advance the breakthrough therapies of tomorrow.

Dr. Alexander was the founding director of the Program in Regulatory Science at the Dana-Farber Cancer Institute and the Harvard/MIT Center for Regulatory Science. He also co-founded the Global Coalition for Adaptive Research, a non-profit organization focused on clinical trial innovations to accelerate the discovery and development of cures for patients with rare and deadly diseases and served as chair of the FDA/Project Datasphere task force on external control arms. He previously co-authored a book on the interpretation of diagnostic tests for medical decision making. Dr. Alexander is an is an affiliated researcher at the MIT Laboratory for Financial Engineering and affiliated faculty of the Harvard Kennedy School Healthcare Policy Program. He was named to Boston Magazines Top Doctors List in 2019, 2020, and 2021.

Previously, Dr. Alexander served as a White House fellow and Special Assistant to the Secretary of Veterans Affairs, where he helped prepare the VA for the transition of administrations, worked to develop a public reporting system for quality, and served as a health policy advisor to the Secretary. Dr. Alexander organized the standup of the VAs Coordinating Council on National Health Reform and directed the activities of its multi-team Health Reform Working Group. He was also a member of the Institute of Medicines Committee on the Governance and Financing of Graduate Medical Education.

Dr. Alexander received his B.A. from Kalamazoo College, M.D. from the University of Michigan Medical School, and M.P.H. from the Harvard School of Public Health. He completed his training in radiation oncology at the Harvard Radiation Oncology Program.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine is a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

Excerpt from:
Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer - Business Wire

NEW YORK, March 30, 2021 /PRNewswire/ -- A new team of pioneering pancreatic cancer researchers has been formed to predict which treatments might work best for individual pancreatic cancer patients based on the molecular traits of tumors. The Pancreatic Cancer Convergence Dream Team is funded by the Pancreatic Cancer Collective, an initiative of the Lustgarten Foundation and Stand Up To Cancer (SU2C), SU2C Canada and Pancreatic Cancer Canada.

The team will be led by Jennifer Knox, MD, the Lewitt Chair in Pancreatic Cancer Research at the Princess Margaret Cancer Centre, part of University Health Network, and professor of medicine at the University of Toronto in Canada, and Elizabeth Jaffee, MD, a professor of oncology and deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland.

"This team's cutting-edge work to better understand the makeup of pancreatic cancers will benefit tens of thousands of cancer patients in the United States and around the world," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, co-chair of the SU2C Canada Scientific Advisory Committee and Institute professor at the David H. Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. "Pancreatic Cancer Collective-supported research has already contributed to a 2013 FDA approval of a combination therapy for advanced pancreatic cancer; the work of this Dream Team is an important next step in determining if that treatment, or another leading treatment, will work best for different pancreatic cancer subtypes."

Pancreatic cancer is the third leading cause of cancer-related death in both the United States and Canada and is exceptionally difficult to treat. The five-year survival rate for pancreatic cancer is around 10% in the United States and 8% in Canada. Additionally, Black people in the U.S. and Canada are more likely to develop pancreatic cancer than whites. In the U.S., the incidence of pancreatic cancer is 19% higher in Black men compared to white men, and 36% higher in Black women compared to white women. The Dream Team hopes to address this disparity by making recruitment of diverse patients a top priority in their research.

The Dream Team recently opened a phase II clinical trial entitled Pancreatic Adenocarcinoma Signature Stratification for Treatment (PASS-01) Trial looking more closely at the two leading treatments for advanced pancreatic cancer. One of those treatments is Modified FOLFIRINOX, which is a combination of four chemotherapy drugs. The other treatment is a combination of chemotherapy drugs gemcitabine and nab-paclitaxel. The U.S. Food and Drug Administration approved that treatment in 2013 based, in part, on the work of a previousSU2C Pancreatic Dream Team, which was a part of the Pancreatic Cancer Collective portfolio.

The two treatments are helpful for some pancreatic cancer patients but have little effect for other patients. The goal of the PASS-01 trial is to uncover more about how the two treatments work. Currently, precision medicine for pancreatic cancer patients includes a comprehensive evaluation of the tumor's genomic profile. But, doctors still don't know enough about the different types of pancreatic cancer to determine whether either treatment will help an individual patient, and if so, which treatment might work best. Building on the findings from a pancreatic cancer clinical trial conducted by the Ontario Institute for Cancer Researchwhich also is a collaborator on the PASS-01 trialpotential predictors of patient response to chemotherapy will be further tested by Knox and Jaffee and their Dream Team colleagues. They also hope the trial will help them learn more about biomarkers within patients' tumors. Their goal is to be able to identify specific biomarkers that indicate whether a pancreatic cancer will respond better to one treatment versus the other.

At the same time, the clinical trial will explore another promising method in fighting pancreatic cancer by uncovering the unique characteristics of individual patients' tumors. Collaborators at Cold Spring Harbor Laboratory in Cold Spring, New York, will create patient-derived organoids (PDOs) from biopsies of trial participants' tumors. The miniature 3-D structures are grown in lab dishes from tiny bits of tumors taken from patients. Scientists then see how the PDOs react to different types of cancer drugs. This work may lead to more effective individualized treatments for pancreatic cancer.

"We have brought together some of the finest pancreatic cancer researchers in North America; the time is right to dig in much deeper to help understand pancreatic cancer," Knox said. "We need to stop assuming one size fits all and instead advance the field by gaining a better understanding of every tumor. We believe our work can help doctors treat patients optimally today while providing a better understanding of this deadly disease into the near future."

"There is a critical need to identify ways that medicine can better treat pancreatic cancers," Jaffee said. "We believe by identifying and learning more about these biomarkers, we can help make that happen. We can give patients more hope that their cancers can be treated effectively."

"Personalized medicine has been a game changer in the treatment of many other cancers and this trial is a significant step toward offering this type of individualized care to metastatic pancreatic cancer patients," said David Tuveson, MD, PhD, chief scientist for the Lustgarten Foundation and director of the Lustgarten Foundation Pancreatic Cancer Research Lab at Cold Spring Harbor Laboratory where pancreatic cancer organoids were co-developed. "The international partnership between these organizations is a great example of collaboration between labs to help physicians make faster, better informed decisions in efforts to provide patients with better outcomes."

Knox and Jaffee have already begun enrolling clinical trial participants at Princess Margaret Cancer Centre and Johns Hopkins. The team hopes to enroll 150 patients in the trial, with four additional locations throughout the United States and Canada opening soon, including Memorial Sloan Kettering Cancer Center in New York City, Northwell Health in Long Island, Dana Farber Cancer Institute in Boston and BC Cancer in Vancouver, B.C.

# # #

Media Contact:Mirabai Vogt-JamesStand Up To Cancer[emailprotected]

About Stand Up To CancerStand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation, a 501(c)(3) charitable organization, was established in 2008 by media and entertainment leaders who utilize these communities' resources to engage the public in supporting a new, collaborative model of cancer research, to increase awareness about cancer prevention, and to highlight progress being made in the fight against the disease. As of 2021, more than 1,950 scientists representing more than 210 institutions are involved in SU2C-funded research projects.

Under the direction of our Scientific Advisory Committee, led by Nobel laureate Phillip A. Sharp, Ph.D., SU2C operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs.

Current members of the SU2C Founders and Advisors Committee (FAC) include Katie Couric, Sherry Lansing, Kathleen Lobb, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, and Ellen Ziffren. The late Laura Ziskin and the late Noreen Fraser are also co-founders. Sung Poblete, Ph.D., R.N., serves as SU2C's CEO. For more information, visitStandUpToCancer.org.

About the Pancreatic Cancer CollectiveThe Pancreatic Cancer Collective is an initiative of Lustgarten Foundation and Stand Up To Cancer to improve pancreatic cancer patient outcomes. Together, these leading cancer research organizations have funded 26 projects for a total of more than $108 million and are attracting new collaborators; employing big data to improve diagnosis of pancreatic cancer; finding new treatments for pancreatic cancer; and supporting the next generation of pancreatic cancer investigators. Engaging thought leaders, researchers, institutions, and companies, the Collective is innovating and accelerating research on the edge of science. For more information, visit PancreaticCancerCollective.org.

About the Lustgarten FoundationThe Lustgarten Foundation is the largest private funder of pancreatic cancer research in the world. Based in Woodbury, N.Y., the Foundation's mission is to cure pancreatic cancer by funding scientific and clinical research related to the diagnosis, treatment, and prevention of pancreatic cancer; providing research information and clinical support services to patients, caregivers and individuals at high risk; and increasing public awareness and hope for those dealing with this disease. Since its inception, the Lustgarten Foundation has directed more than $200 million to research and has assembled the best scientific minds with the hope that one day, a cure can be found. Thanks to separate funding to support administrative expenses, 100 percent of your donation funds pancreatic cancer research. For more information, visit Lustgarten.org.

About Stand Up To Cancer CanadaStand Up To Cancer Canada is a Canadian registered charity (Reg: # 80550 6730 RR0001), launched by the U.S.-based Entertainment Industry Foundation in 2014. Stand Up To Cancer Canada (SU2C Canada) raises funds to support collaborative cancer research teams, as well as education and awareness programs conducted in Canada.

Under the direction of our SU2C Canada Scientific Advisory Committee, co-led by Alan Bernstein, Ph.D., president of the Canadian Institute for Advanced Research (CIFAR) and Nobel laureate Phillip A. Sharp, Ph.D., SU2C Canada operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs. SU2C Canada currently supports three "signature" Dream Teams engaging dozens of the best and brightest researchers in different disciplines from 15 institutions across the country.

In addition to a board of leading Canadian broadcaster representation, SU2C Canada is guided by the SU2C Council of Founders and Advisors (CFA) including Katie Couric, Sherry Lansing, Kathleen Lobb, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, and Ellen Ziffren. The late Laura Ziskin and the late Noreen Fraser were also co-founders. Sung Poblete, Ph.D., RN serves as SU2C CEO. The CFA includes entertainment industry leaders who utilize these communities' resources to engage the public in supporting this new, collaborative model of cancer research, to increase awareness about cancer prevention, and to highlight progress being made in the fight against the disease. For more information on Stand Up To Cancer Canada, visitStandUpToCancer.ca.

About Pancreatic Cancer CanadaPancreatic Cancer Canada is fighting to raise survival rates for the world's toughest cancer investing in targeted research, increased awareness and patient support, community activation and advocacy. We have taken on one of the world's deadliest cancers a disease with virtually no progress in survival in the past 40 years and a 92% mortality rate. We are aggressively fighting it with investments in research aimed at greater understanding of this cancer and better treatment options. At the same time, we are working to educate physicians about faster diagnosis and with patients/families to support them as they face the realities of this cancer in their lives. To learn more, please visitwww.pccf.ca.

SOURCE Stand Up To Cancer

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New Clinical Trial Studies Pancreatic Cancer Tumor Traits To Uncover Better Treatment Options - PRNewswire

AUSTIN, Texas, March 31, 2021 /PRNewswire/ --Natera, Inc.(NASDAQ: NTRA), a pioneer and global leader in non-invasive genetic testing and analysis of cfDNA, and Tesis Labs, a US multi-region lab services provider with labs in Colorado, Texas and Arizona, announced a strategic partnership in the field of prenatal genetic testing.

The collaboration will allow Tesis to broaden its portfolio of genetic testing offerings and participate in the fast growing screening market for over 4 million pregnancies in the United States. Tesis's state-of-the-art and highly scalable genetics laboratory in Lafayette, Colorado can serve many regions of the U.S. including Texas, Arizona and Colorado.

"Natera is pleased to partner with Tesis Labs to improve patient testing access and convenience in a number of critical regional markets for both Natera and Tesis," said Ramesh Hariharan, General Manager of Natera's Women's Health business.

"We are honored to partner with Natera," said Tesis Labs CEO Ron King. "Working together will offer new opportunities for early screening, allowing more informed treatment and care decisions for women and their families. Our combined expertise and technology will play a major role in helping patients."

About Tesis Labs

Tesis Labs' genetically integrated medical platform has revolutionized targeted genetic sequencing. Our mission is to change medicine by providing physicians, hospitals, and researchers with the tools to help patients treat and overcome major chronic conditions such as heart disease, lung disease, cancer, and diabetes through advanced genetic testing. Tesis offers healthcare providers, and physicians' access to our unique genetic testing and precision medicine, enabling them to create personalized care plans for treating chronic diseases individually and across generations. We also enable medical device companies and pharmaceuticals to bring new products to market and create a robust repository of genetic data and research. Visitwww.tesislabs.comto learn more.

Media Contact: Kim Warth, Amendola Communications303-918-9205[emailprotected]tingpr.com

About Natera

Naterais a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investors and http://www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [emailprotected]

SOURCE Natera, Inc.

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Natera and Tesis Labs Announce Strategic Collaboration on Prenatal Genetic Testing - PRNewswire

Dublin, April 02, 2021 (GLOBE NEWSWIRE) -- The "Biomarkers: Technologies and Global Markets 2021" report has been added to ResearchAndMarkets.com's offering.

This new report, Biomarkers: Technologies and Global Markets, provides a comprehensive analysis of the biomarkers market in a global context, including market forecasts and sales through 2025. The report analyzes the market, segmenting it into various product offerings (i.e., instruments, consumables [reagents, kits and panels], services and software). Segmentation also provides analysis by popular technology type (genomics, proteomics and metabolomics, imaging and bioinformatics).

This study surveys the biomarker market by therapeutic area (cancer, cardiovascular and metabolic diseases, infectious diseases, neurodegenerative diseases, autoimmune diseases and others. End-users include academic institutes, pharma and biotechnology companies, clinical research organizations, hospitals and diagnostics. Geographic regions include North America, Europe and Emerging markets. Emerging markets include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America, etc.

This report features new product developments and patents that are boosting global growth in this market.

This report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on changing market trends, market players and leading products. This chapter also covers mergers and acquisitions and other collaborations or partnerships that are expected to shape the industry.

Strengths, weaknesses, threats and opportunities are expected to play a role in the diagnostic biomarkers market. These are evaluated in detail.

The scope of the report excludes in vitro diagnostic products and regulatory aspects. Digital biomarkers are not covered in this report.

Report Includes:

Biomarkers, the biological indicators of health and disease, have come a long way, from being used as simple measurements of clinical diagnosis, to becoming essential tools in the clinical space and drug discovery and development. The utility of biomarkers has been expanding over the last couple of decades, due to the potential for predicting disease diagnosis and prognosis, treatment response, pharmacokinetics of drugs and monitoring therapy. During the COVID-19 pandemic, boosted R&D for novel diagnostics led to the approval of many biomarker-based diagnostic tests for early and rapid detection of the SARS-CoV-2 virus.

Pharmaceutical and biopharmaceutical drug developers struggle to overcome escalating cost barriers and high drug attrition rates in late-stage clinical trials. Biomarkers are promising tools to address drug development challenges. offering the prediction of drug toxicity and efficacy in early stages. The 21st Century Act allowed the Food and Drug Administration (FDA) to publish guidelines for Biomarker Qualification for use in drug development programs, paving the way for biomarker inclusion into drug development through either the drug approval process or the Biomarker Qualification Program.

Biomarkers are extremely useful in clinical trials, increasingly used to identify populations for a study, monitor therapeutic response and identify side effects. There is an emerging market of clinical research organizations (CROs) carrying out clinical trial recruitment and other services, while expanding technical expertise in bioanalytical and biomarker development. This enables pharmaceutical clients access to biomarker discovery and development.

The global biomarkers market is growing at a significant pace, driven by an explosion of publications and clinical trials. Enhanced analytical methods and the development of new, sophisticated and sensitive multiplex methods in gene expression analysis, proteomics, metabolomics and transcriptomics bring huge momentum to this market. The development of multi-biomarker assays, novel immunoassays and multi-modal imaging and mass spectrometry methods further drive market growth.

Collaborations and strategic partnerships, mergers and acquisitions and other deals between private and public players are on the rise. Companies are strengthening technical know-how and expanding product portfolios in order to offer enhanced services and new offerings to the biomarker research community. Precision medicine, particularly in the field of cancer, has contributed tremendously to an interest in biomarkers, with growing adoption of biomarkers in companion diagnostics and selecting targeted patient populations for high-value drugs. Other therapeutic areas, such as cardiovascular, neurodegenerative and autoimmune diseases are getting noticeable attention in biomarker research.

Challenges for this market, remain in the form of disparity in biomarker definitions at an international level and lack of any defined regulatory guidance for use in R&D. There is still a need to develop sensitive and robust methods of analysis for low concentration analytes via methods that can be validated. Lack of skilled manpower and the high cost of technology are other challenging factors.

Positive approaches in biomarker research, effective dialogue and collaborations between all stakeholders is expected to address challenges and take this market forward in coming years.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Chapter 4 Market Breakdown by Product Type

Chapter 5 Market Breakdown by Technology Type

Chapter 6 Market Breakdown by Therapeutic Area

Chapter 7 Market Breakdown by End User

Chapter 8 Industry Structure

Chapter 9 Clinical Trials

Chapter 10 Patent Analysis

Chapter 11 Analysis of Market Opportunities

Chapter 12 Company Profiles

Chapter 13 Appendix: Abbreviations/Acronyms

For more information about this report visit https://www.researchandmarkets.com/r/xjd6q0

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Outlook on the Biomarkers Global Market to 2025 - Rising Incidence of Diseases Presents Opportunities - GlobeNewswire

Cerba Healthcare, headquartered in France and firmly established in Europe and Africa through its historical routine and specialty biology expertise, also operates globally through its clinical trials business unit for the validation of new compounds and vaccines. It stands as a unique group in the diagnosis market, covering the needs for diagnostic tools and expertise for patients, physicians, hospitals and the pharmaceutical industry.

With this new partnership, Cerba HealthCare reinforces its capital structure with its existing shareholders -more than 400 long-time biologists and managers- and its long-term partner, PSP Investments, to sustain the Group's development strategy and current transformation.

Catherine Courboillet, CEO, Cerba HealthCare, states: "Over the past four years, Partners Group has shown a comprehensive understanding of our market and unwavering support in sustaining Cerba HealthCare's growth strategy. In order to continue to fulfill the Group's long-term development, we are excited to welcome a partner that shares the same vision and values, as well as a strong understanding of the importance of cutting-edge, personalized services. It is critical to keep on investing heavily in innovation, IT security and talents in order to drive further and faster our on-going transformationtowards better healthcare services for patients. With EQT, we have chosen an experienced partner that will strengthen our European positioning while helping us expand into new markets."

Nicolas Brugre, Partner, Investment Advisor at EQT Partners and Head of EQT France, comments:"EQT has followed Cerba HealthCare for a long time and we are deeply impressed with the company's unique platform for medical diagnoses and superior scientific expertise. Cerba HealthCare is a purpose-driven company with a culture that is well-aligned with EQT's values and we are happy to partner with its management team and with PSP Investments. EQT Private Equity is committed to invest in and future-proof Cerba HealthCare for the long-run to best serve patients and healthcare professionals."

Kim Nguyen, Partner, Private Equity Services, Partners Group, adds: "Cerba HealthCare operates in an important sector and we are proud to have successfully contributed to the sustainable growth strategy of the Company over the last four years. In line with Partners Group's focus on positive stakeholder impact and entrepreneurial governance, Cerba HealthCare has not wavered in its commitment to responding to the COVID-19 crisis. During our holding period, the Company has transformed into a market leader, penetrating new international markets, including in Africa and Italy, further consolidating its expertise in clinical trials and securing leadership in the veterinary biology sector. We are convinced Cerba HealthCare is poised for lasting success and that, after our strong and collaborative partnership, it is the right time and opportunity for all stakeholders that the Company move into its next phase of growth."

Simon Marc, Senior Managing Director and Global Head of Private Equity, PSP Investments, said: "Since our initial partnership with Cerba HealthCare in 2017, the company has gone from strength to strength, and we are excited to continue supporting Catherine and her talented management team as long term-partners. We look forward to welcoming EQT who has been one of PSP Investments core partners for many years, and who brings tremendous expertise in European healthcare. Together, we will provide the long-term strategic capital to support Cerba HealthCare in achieving its full potential through its next phase of development as a European leader in medical diagnostics."

Following the completion of the deal, which is subject to administrative notifications and regulatory approvals, EQT Private Equity and PSP Investments will work with Cerba HealthCare's management team, led by CEO Catherine Courboillet, to support the numerous growth opportunities of the business. These include the continuation of the Company's highly successful M&A strategy on a global scale, as well as the acceleration of organic growth and development in other segments.

About Cerba HealthCareCerba HealthCare, a leading player in medical diagnosis, aims to support the evolution of health systems towards more prevention. It draws on more than 50 years of expertise in clinical pathology to better assess the risk of diseases development, detect and diagnose diseases earlier, and optimize the effectiveness of personalized medicine.

Every day, on 5 continents, the Group's 8500 employees sustain the transformation of medicine, driven by one deep conviction: to advance diagnosis is to advance health.Cerba HealthCare, enlightening health.

About PSP InvestmentsPSP Investments is one of Canada's largest pension investment managers with approximately $169.8 billion of net assets as of March 31, 2020. It manages a diversified global portfolio of investments in public financial markets, private equity, real estate, infrastructure, natural resources and private debt. Established in 1999, PSP Investments manages net contributions to the pension funds of the federal Public Service, the Canadian Forces, the Royal Canadian Mounted Police and the Reserve Force. Headquartered in Ottawa, PSP Investments has its principal business office in Montreal and offices in New York, London and Hong Kong. For more information, visit investpsp.com or follow PSP Investments on Twitter and LinkedIn.

About Partners GroupPartners Group is a leading global private markets firm. Since 1996, the firm has invested over USD 145 billion in private equity, private real estate, private debt and private infrastructure on behalf of its clients globally. Partners Group is a committed, responsible investor and aims to create broad stakeholder impact through its active ownership and development of growing businesses, attractive real estate and essential infrastructure. With over USD 109 billion in assets under management as of 31 December 2020, Partners Group serves a broad range of institutional investors, sovereign wealth funds, family offices and private individuals globally. The firm employs more than 1,500 diverse professionals across 20 offices worldwide and has regional headquarters in Baar-Zug, Switzerland; Denver, USA; and Singapore. It has been listed on the SIX Swiss Exchange since 2006 (symbol: PGHN). For more information, please visit http://www.partnersgroup.comor follow us on LinkedInor Twitter.

About EQT EQT is a purpose-driven global investment organization with more than EUR 84 billion in raised capital and over EUR 52 billion in assets under management across 17 active funds. EQT funds have portfolio companies in Europe, Asia-Pacific and North America with total sales of more than EUR 27 billion and approximately 159,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.More info: http://www.eqtgroup.com Follow EQT on LinkedIn, Twitter, YouTube and Instagram

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IRVINE, Calif.--(BUSINESS WIRE)-- World-renowned cancer research and treatment center City of Hope has received a $50 million gift from Lennar Foundation, the charitable arm of homebuilder Lennar Corporation. This transformational gift of hope is the largest single philanthropic contribution to City of Hope Orange County. It will expedite the health care organizations bold plans to invest $1 billion to develop and operate a comprehensive cancer campus in Irvine, California, and establish an Orange County network of advanced cancer care and research that will speed groundbreaking treatments directly to a community with growing needs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210331005094/en/

Lennar Foundation Cancer Center, opening in 2022 (Photo: City of Hope)

The future 190,000-square-foot Lennar Foundation Cancer Center at City of Hope Orange County will be located on 11 acres at Five Points Great Park in the heart of Irvine. It will bring best-in-class cancer care, pioneering research and lifesaving treatments to the countys 3.2 million residents. Construction is already underway on the comprehensive cancer center, which will open in 2022. In addition, Orange Countys only hospital dedicated exclusively to treating and curing cancer will open at City of Hope Irvine in 2025.

City of Hopes presence in Orange County offers local access to City of Hopes National Cancer Institute-designated comprehensive cancer center with world-renowned cancer physicians and researchers who are singularly focused on finding better treatments and cures.

Lennar Foundation Cancer Center at City of Hope Orange County will bring to the region a host of distinguishing services, including:

As the country emerges from the COVID-19 pandemic, Lennar Foundations extraordinary contribution underscores the importance of investing in local health care resources and increasing access to leading-edge care. For Orange County, it is a reminder that cancer does not stop, and that City of Hopes mission is more important than ever.

Lennar has a long history in Orange County of developing thriving communities, including helping form the vision for a world-class recreation and lifestyle destination. This gift is an extension of this longstanding commitment to improving lives in the regions Lennar helps shape. A portion of the gift to City of Hope is designated to support clinical translational research between City of Hope and the Sylvester Comprehensive Cancer Center of the University of Miami, thus uniting two organizations supported by Lennars generosity who share similar goals in developing new treatments and cures for patients with cancer.

City of Hope and Sylvester Comprehensive Cancer Center serve two of the most diverse areas in the United States. Both organizations are committed to conducting high-impact research that addresses the cancer burden in their communities. This gift will enable collaborative, translational science that will drive innovation and catalyze timely and necessary progress towards health equity.

Lennar Foundations gift to City of Hope is a generous continuation of Lennars longstanding support of the comprehensive cancer center. Jon Jaffe, co-chief executive officer and co-president of Lennar Corporation, is a member of City of Hopes Construction Industries Alliance Leadership Advisory Council, which raises funds for cancer treatment and research. In recognition of his contributions, Jaffe was awarded City of Hopes highest honor The Spirit of Life Award in 2004.

City of Hope Newport Beach, the first phase of City of Hope Orange Countys expansion, opened in early 2020, providing Orange County residents first-time local access to world-renowned physicians backed by the powerful City of Hope network. City of Hope plans to open other clinical network locations across the region.

Supporting quotes

Robert Stone, president and CEO, City of HopeHelen and Morgan Chu Chief Executive Officer Distinguished Chair

This is the start and it is a monumental start to show the nation that our work in Orange County will catalyze incredible achievements in health care. Visionary donors and volunteers have been foundational to City of Hopes 108-year history, and we are deeply grateful to the Lennar Foundation for their extraordinary contributions and longstanding support. With this gift, we will achieve the nexus of unsurpassed medical expertise, future-focused communities, groundbreaking technology and innovation, all for the single purpose of saving lives. This partnership supports a system of care delivery that provides state-of-the-art treatments, the latest scientific and medical discoveries, and unprecedented access that will serve as a model across the country.

Stuart Miller, executive chairman, Lennar Corporation

At Lennar, we are committed to building communities, and we are pleased to support City of Hope to help build the future of cancer care. Together, we are building a state-of-the-art center for advanced cancer care and research that will make a difference in the lives of so many by turning science into practice and hope into reality.

Nicole Petersen Murr, grateful Orange County patient

City of Hope saved my life. My family and I will be forever grateful to my doctor and care team. Anyone who has heard the words You have cancer knows how those words change your life and affect every piece of it. I want everyone who hears those words to have the same compassionate care and access to the latest treatments that I had. Having City of Hope in Orange County changes everything for cancer patients present and future. Im so grateful to have this world-renowned care in my own community.

Annette M. Walker, president, City of Hope Orange County

This generous gift of hope is a historic moment for City of Hope. Thank you to Lennar Foundation, which is united in our vision and understands the urgency of our work, helping us ensure that our promise to Orange County will be fulfilled. We are building a place of hope and healing that will serve residents of Orange County and beyond for generations to come. Every one of us has been touched by cancer and we want all who are impacted by this disease to know we are here for you, your family, friends and neighbors.

Jon Jaffe, co-chief executive officer and co-president, Lennar Corporation

City of Hope is a leader in the treatment of and race to find a cure for cancer, and its gratifying to know that, with this gift, we will make a positive impact by expanding access to care and advancing the research that will treat, prevent and ultimately eliminate cancer we hope this contribution will encourage other philanthropic leaders to support City of Hope in the fight against cancer.

Kristin J. Bertell, chief philanthropy officer, City of Hope

This important contribution is a clear demonstration of the power of philanthropy to accelerate positive changes in health care delivery, spur advances in science, research and treatment, and give real hope to patients, families and communities. Lennar Foundations generosity continues a long philanthropic legacy that is the cornerstone of our history. There is no doubt that this gift will have a long-lasting impact, and we look forward to engaging the community to make the vision for Orange County and the future of cancer care a reality.

For more information on the progress of City of Hopes Orange County expansion and its first clinical network location in Newport Beach, please visit CityofHope.org/OC.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs are based on technology developed at the institution. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHope, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their health care partners by providing access to City of Hopes exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Lennar Corporation

Lennar Corporation, founded in 1954, is one of the nation's leading builders of quality homes for all generations. Lennar builds affordable, move-up and active adult homes primarily under the Lennar brand name. Lennar's Financial Services segment provides mortgage financing, title and closing services primarily for buyers of Lennar's homes and, through LMF Commercial, originates mortgage loans secured primarily by commercial real estate properties throughout the United States. Lennar's Multifamily segment is a nationwide developer of high-quality multifamily rental properties. LENX drives Lennar's technology, innovation and strategic investments. For more information about Lennar, please visit http://www.lennar.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210331005094/en/

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City of Hope Receives $50 Million Gift From Lennar Foundation to Build the Future of Cancer Care - BioSpace