StemCell Therapy

A new study presented at the 14th Annual North American Young Rheumatology Investigator Forum (NYRIF 2020) found an association between seropositive rheumatoid factor (RF) or the presence of anti-cyclic citrullinated antibodies (ACPA) and an increased prevalence of interstitial lung disease (ILD) among patients with rheumatoid arthritis.

The retrospective case-control review, led by Samarth Mathapathi, MD, Resident at Scripps Green Hospital, examined various combinations of RF and ACPA serotypes among patients in order to determine associations with ILD prevalence.Furthermore, they compared selected outcomes to see whether seropositivity can help predict the course of rheumatoid arthritis ILD.

Mathapathi and team assessed a total of 2084 adult patients with rheumatoid arthritis with and without ILD. Of the total, 82 had ILD, and 2002 did not.

They excluded patients with other rheumatologic or pulmonary conditions.

Furthermore, the team defined RF positive (RF (+)) as RF >15 IU/mL, and ACPA positive (ACPA (+)) as ACPA >6 IU/mL.

In their analysis, patients were divided into groups according to RF and ACPA status. Then they compared ILD prevalence, pulmonary function tests, progression of CT/chest X-ray, average pulmonary artery pressures, home oxygen dependency, all-cause mortality, and hospitalization for respiratory failures rates among the cohorts.

Thus, the investigators noted that prevalence of ILD was 6.3% and 5.2% in the RF (+) / ACPA (+) and RF (+) / ACPA (-) groups, respectively (P = .534).

Prevalence was 3.9% in the RF (-) / ACPA (+) group and 1.3% in the RF (-) / ACPA (-) group (P < 0.05).

Furthermore, the mean titers of ACPA and RF in all ILD cohorts were 397 IU/mL and 484 IU/mL, respectively.

For those without ILD, means titers were 235 IU/mL for RF and 250 IU/mL for ACPA.

When compared across all the ILD groups, the outcomes among all other aforementioned measures were not significantly difference (P > .05).

The only notable exception was progression on imagingwhich was significant only in the RF (+) / ACPA (-) group. Thus, the investigators believed that this finding suggests a potential difference in disease course or other confounding underlying conditions.

Positive and higher titers of ACPA or RF may help predict development of RA-ILD but may not help prognosticate disease course, they concluded.

They acknowledged that larger and prospective studies would be necessary to confirm and validate their findings.

Concomitant rheumatoid arthritis and ILD has a varying prevalence, ranging from 3.2-6.0 cases per 100,000. The median survival rate is 7.8 years.Notable risk factors include age, female sex, and severity of rheumatoid arthritis.

The study, Comparison of Selected Outcomes in Seropositive vs. Seronegative Rheumatoid Arthritis-Associated Interstitial Lung Disease (RA-ILD), was presented at NYRIF 2020.

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Seropositive Antibodies Linked with Prevalence of Rheumatoid Arthritis-Associated ILD. - MD Magazine

'For people with arthritis, it is all about accessibility and comfort,' says Michael Kulava, who lives with rheumatoid arthritis himself and will be taking part in New York Fashion Week

A world-class fashion designer,who now lives locally,is helping those suffering from a painful ailment by bringing awareness to the New York stage.

Michael Kuluva is a fashion designer who has travelled the world and now calls Barrie home. Kuvula also lives with rheumatoid arthritis, but he doesnt let it define or hinder him. The autoimmune disorder primarily affects joints and can be very painful, something Kuvula knows all too well.

I was diagnosed 12 years ago and I didnt really know what to expect, the 37-year-old said. It has been a tough road at times, but you learn to live with and deal with all that it comes with.

Kuluva has even taken his passion for fashion design and used it to not only bring awareness to arthritis, but also help those who suffer from it.

The Newest Normal virtual event will premiereduring New York Fashion Week on Sept. 16 at 8 p.m. on the Virtual Fashion Show website and on YouTube.

Kuvula needed to film his show with models and a crew, but during COVID timesthat was tricky.

I was supposed to get back to the States, but obviously international travel couldnt happen. We filmed it here in downtown Barrie with local models and very few people in order to follow COVID protocol,Kuvula said. It was a very unique event and makes you realize that when you want to accomplish your goals, you can find a way.

Kuluva has been a part of New York Fashion Week for the last 11 seasons and will be a prominent figure in the 2020 edition. This years collection from the designer is titled Tumbler and Tipsy and includes clothes that are arthritis-friendly.

For people with arthritis, it is all about accessibility and comfort. Buttons are no good, so Ive altered that a bit with zippers, straps and other easy-to-wear items,Kuluva said. We know how to live with the discomfort, but we shouldn't have to let it stop us from getting out there and wearing what we want.

This years Kuluva collection is being described as deliberately sassy and also includes hand-painted, glow-in-the-dark details thoughtfully placed to emphasize where people living with arthritis experience pain.

It is fun, obviously, but it also highlights the pains that we experience that many dont know we have. Glowing over the joints and other spots that experience pain is a justa way to bring awareness to arthritis, said Kuluva.

Kuluva has travelled all over the world and in what he called, the different realms of New York, Los Angelesand Europe.

For the last four years, he has called Barrie home with his partner and enjoys everything about the region, even dedicating a line of clothes to it.

Barrie is wonderfuland the whole area is beautiful. Id obviously been to Toronto before and being in Barrie is even so close to Muskoka, said Kuluva. I have a Tipsy line of clothes for Muskoka, Toronto and the Canadian feel.

For more on Kuvula and his work, click here to see his website.

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Local fashion designer unveiling new line of arthritis-friendly clothing - OrilliaMatters

This is the time of year when fresh produce is at its peak.

The farmers markets and grocery stores are an abundance of natures glory. Fruit is literally falling off the trees. Home gardens are bursting with joyful rewards of months of labor and love.

Its also a time of year when I see more arthritis patients joints seem to be acting up or more troublesome. Folks often attribute this to using their hands more in the garden, painting projects, etc. Sometimes over-work is absolutely the culprit. And sometimes it can be tied back to eating an abundance of garden booty salsa, green chile, gazpacho or tomatoes warm from the vine.

What do these foods have in common? They are part of the nightshade, or Solanaceae, family. This group of foods is high in glycoalkaloids, especially solanine. It is theorized that these glycoalkaloids can be pro-inflammatory in some people and could be a contributor to arthritic pain. This class of foods includes potatoes, tomatoes, all peppers, eggplant, tomatillos, paprika and cayenne. The nightshade family does not include sweet potatoes, yams or black pepper.

The easiest way to know if these are foods that are causing more pain in your joints is simply to cut them out for 3-4 weeks completely. This is one of the hardest recommendations I make in my practice because this time of year the nightshade foods are so delicious! Veggies in the nightshade family are also high in nutrients, especially vitamins C and A. However, both osteoarthritis and rheumatoid arthritis can be debilitating and neither have great Western medical interventions available. The treatments that are offered often carry their own concerning side effects.

Adjusting your diet to see if certain foods are impacting you is a great way to take your health into your own hands. It doesnt require any testing and is free! There are a couple simple guidelines that can help this be more successful for you. The first is to be diligent and not cheat. You must strictly eliminate the foods in question for at least 3 weeks no exception, otherwise youll never know for sure. Choose a time frame that works for you having start and end dates are essential. (It helps to know theres a light at the end of the tunnel!) Look at your calendar and plan for what you might do if you have events scheduled. Take some time to clear out the foods youre avoiding from your kitchen and think about what you might eat instead. For example, if you love pasta, pesto would be a great alternative to red sauce. Take time each day to record the severity of your symptoms. It is impossible to remember what your pain was like 2 weeks ago and can be helpful to notice if it dropped from a 7 to a 4, as opposed to saying it still hurts.

Finally, connect with your deeper why. If you didnt have joint pain, what would that create in your life? Write that down and keep it on your fridge, in your car and your bathroom to keep you inspired about whats really important.

Remember, not everyone will have this reaction to nightshades. And if you notice that they impact you, play with those foods in moderation. You can also just eat one of the foods (like peppers) and see how that feels in your body it might be that a particular food within the group is more of an issue. Either way, youll be more connected to you.

Nicola Dehlinger is a naturopathic doctor at Pura Vida Natural Healthcare in Durango. She can be reached at 426-1684 or http://www.puravidahealthcare.com.

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Nightshades and arthritis are often connected - The Durango Herald

Maintaining a healthy weight plays an important role in managing psoriatic arthritis. Obesity causes low-grade inflammation, as fat tissue churns out inflammatory proteins, including cytokines, chemokines, and adipokines. Being overweight or obese has been linked to an increased risk of developing psoriatic arthritis, an inflammatory condition, and making it more difficult to manage.

Excess weight puts more pressure on your joints, which can lead to injury and inflammation. Whats more, excess weight can interfere with medications that treat psoriatic arthritis, so they dont work as well. A review published in May 2018 in the journal PLoS ONE found that obesity was linked to a 60 percent greater chance that a class of biologic drugs commonly used to treat psoriatic arthritis, called tumor necrosis factor (TNF) inhibitors, wouldnt work.

The link between obesity and psoriatic arthritis is very complex and not adequately understood, says John Davis, III, MD, a clinical rheumatologist who specializes in psoriatic arthritis at Mayo Clinic in Rochester, Minnesota. We believe that [obesity] drives inflammation, providing the link to the joint disease.

Psoriatic arthritis is also linked to other health conditions, such as heart disease, diabetes, and metabolic syndrome. For all of these, Losing weight and maintaining weight in a healthy range is important, says Melissa Ann Prest, DCN, RDN, a spokesperson for the Academy of Nutrition and Dietetics.

The good news: Weight loss has been linked to an improvement in psoriatic arthritis symptoms, including painful, swollen joints and fatigue. Its probably reducing the inflammatory burden, says Dr. Davis.

American College of Rheumatology and National Psoriasis Foundation (NPF) guidelines, published in November 2018 in the journal Arthritis & Rheumatology, recommend weight loss for all obese people who have psoriatic arthritis to help improve their response to medication. Losing weight helps psoriatic arthritis symptoms in other ways, as well, explains Rajat Bhatt, MD, a rheumatologist with Memorial Hermann Health System in Texas. It decreases inflammation and stress on the joints and lowers uric acid levels linked to gout another joint condition common in people who have psoriatic arthritis.

And weight loss doesnt have to be major. Research has found that overweight and obese people with psoriatic arthritis who lost just 5 percent of their body weight were more likely to have minimal disease activity.

Although psoriatic arthritis symptoms such as fatigue and stiff, achy joints can make it more challenging to move, its possible to drop extra pounds with the right strategies and support. Here are a some tips to help you lose weight and improve your symptoms.

Daviss number one tip for weight loss in people who have psoriatic arthritis is to eliminate added sugars. They provide extra calories that dont benefit your body and can increase chronic inflammation, upping your risk of related conditions, such as obesity and diabetes.

Another reason to cut back on sugar: A review published in April 2020 in the journal Rheumatology and Therapy found that people who have psoriatic arthritis are significantly more likely to have type 2 diabetes than the population at large, possibly because inflammation of the skin and joints may affect glucose metabolism. Davis recommends limiting simple sugars and carbohydrates in your diet. Sugar hides in processed foods, cereal, yogurts, and juices, he says.

The NPF also recommends cutting out the following:

Foods from these sources are typically going to be higher in calories and trans fat, which can contribute to weight gain and inflammation, says Dr. Prest.Because cutting out these foods helps reduce inflammation, which worsens psoriatic arthritis, it may also help reduce psoriatic arthritis symptoms, explains Dr. Bhatt.

Research suggests that eating lots of fruits and vegetables can help you lose weight by keeping you full and satisfied on fewer calories, according to the Centers for Disease Control and Prevention (CDC). People should definitely eat more fruits and veggies, adds Davis.

A plant-based diet can also help decrease inflammation levels, which may reduce psoriatic arthritis symptoms, adds Bhatt. He specifically recommends the Mediterranean diet, which is rich in anti-inflammatory omega-3 fatty acids.

Dietary guidelines from the medical board of the NPF published in August 2018 in JAMA Dermatology, also recommend a Mediterranean diet, consisting of at least:

Make vegetables the star of your meal by filling half of your plate with non-starchy vegetables, and go with a serving of fruit or a serving of a vegetable for snacks, says Prest.

Its easy to confuse thirst for hunger, according to the NPF. So be sure to drink enough water to help with your weight loss efforts. About eight 8-ounce glasses per day is a good goal, according to the Mayo Clinic. Youll know youre hydrated if your urine is clear to light yellow.

Physical activity helps reduce inflammation and pain. Weight loss guidelines from the CDC recommend at least 150 minutes of moderate physical activity per week. Exercise is great for your overall health and to break through those weight loss plateaus, says Prest.

Staying physically active is especially important for people who have psoriatic arthritis, as metabolic syndrome has been linked to psoriatic arthritis disease activity and medication effectiveness, says Bhatt. Exercise can help you tackle metabolic syndrome by reducing inflammation and improving muscular metabolism. And thats not all. Exercise can increase range of motion in the joints and maintain joint flexibility and muscle strength, says Bhatt. Physical activity also increases pain tolerance, helping psoriatic arthritis symptoms feel less debilitating, and decreases uric acid, which reduces joint pain in people who also have gout, he adds.

If youre experiencing a lot of joint pain in your lower extremities, Bhatt recommends swimming a few laps. Swimming is a good low-impact activity for those who have access to a pool and enjoy it, says Davis.

Walking is a great exercise for people with psoriatic arthritis to lose weight, says Davis. Maintaining daily activity and step counts [helps] to increase metabolism, he says. When combined with dietary changes, walking supports weight loss, according to the Mayo Clinic, and is especially important for weight loss maintenance.

A study published in December 2018 in the journal BioMed Research International suggests that weight-bearing aerobic exercises, such as walking, may help reduce the risk of bone loss. Thats important, as another study, published in July 2020 in Annals of the Rheumatic Diseases, suggests that psoriatic arthritis treatments may increase the risk of osteoporosis.

If you need extra motivation, use a fitness tracker to track your steps. Set small, manageable goals that slightly challenge you. And listen to your body: Its natural to feel a bit sore or tired the next day, but take it easy if you feel pain.

Once your routine is no longer challenging, consider increasing the intensity. The body always has to be challenged. Choose something you like, so you can stick to a long-term plan, says Bhatt.

Resistance training, which includes weight lifting and body weight exercises, such as squats, can help with both weight loss and overall fitness. One small study published in February 2018 in the journal Clinical Rheumatology found that people with psoriatic arthritis who did resistance training twice a week for 12 weeks reduced their disease activity and pain and improved their quality of life.

Whats more, building muscle helps with weight loss. Thats because muscle burns more calories than fat does, even at rest, according to the Mayo Clinic. Lifting weights may be even more important when youre cutting back on calories, because your body sheds some muscle mass along with fat when you lose weight. The CDCs weight loss guidelines recommend incorporating strength-training activities that use all the major muscle groups two days a week.

If joint pain makes this kind of exercise challenging, ask your doctor for tips on how to get started safely.

The dietary guidelines from the NPF recommend a reduced-calorie diet for people with psoriatic arthritis who are obese. Talk to your doctor to determine the right goal for you. Tracking your calorie intake can be especially helpful. Studies show that just keeping a simple food journal reduces intake, because it makes you more aware of what youre eating and helps you figure out a better choice, says Prest.A study published in February 2019 in the journal Obesity followed 142 people on their weight loss journey for 24 weeks and found that those who more often used an online food journal reported more weight loss after six months.

I have used the photo journal technique with many clients, and they have had great success in reaching their weight loss goals, says Prest. Free apps and online tracking tools also give you a great estimate of your overall diet, but keep in mind theyre not 100 percent accurate, she adds.

A lack of sleep is linked to impairments in glucose metabolism and an increased risk of type 2 diabetes, metabolic changes, and inflammation, according to a review published in March 2015 in the journal Diabetology and Metabolic Syndrome. This can affect not only your weight loss efforts but also your overall health, including psoriatic arthritis symptoms.

A good nights sleep helps with pain sensitization and improves pain tolerance, and therefore, psoriatic arthritis symptoms might be better, says Bhatt. When the body rests, it rids itself of toxins, which helps improve inflammation. And good sleep helps with weight loss. Davis suggests people with psoriatic arthritis aim for at least 7 to 8 hours of sleep each night.

A study published in October 2018 in the journal Reumatologia suggests that many people who have psoriatic arthritis have trouble sleeping. A few of Bhatts top sleep hygiene tips:

If [youre] struggling, seeing a dietitian is a good idea, says Davis. A dietitian can help you develop a customized meal plan, which can be especially helpful for people who have psoriatic arthritis. People with psoriatic arthritis may find that they have other food sensitivity issues that may contribute to problems with weight loss. Working with a registered dietitian nutritionist is a great way to ensure youre eating the right amount for weight loss, says Prest. You can search for a registered dietitian nutritionist near you at eatright.org.

If youre struggling with exercise, a physical therapist or personal trainer can develop a fitness routine suited to your needs.

Finally, keep at it, because even small changes can be powerful. We often overemphasize pharmaceutical therapies and underemphasize lifestyle changes, says Bhatt, but lifestyle changes are equally important for all arthritis patients.

Link:
Psoriatic Arthritis-Friendly Weight Loss Tips - Everyday Health

Data Bridge Market Research has recently published the Global research Report TitledArthritis Market. The study provides an overview of current statistics and future predictions of the Global Arthritis Market.The study highlights a detailed assessment of the Market and displays market sizing trends by revenue & volume (if applicable), current growth factors, expert opinions, facts, and industry validated market development data.

Global arthritis market is expected to register a substantial CAGR in the forecast period of 2019-2026. The report contains data from the base year of 2018 and the historic year of 2017. This rise in market value can be attributed to the increasing awareness regarding the disease and the modes of its treatment.

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The report gives explanations about market definition, currency and pricing, market segmentation, market overview, premium insights, key insights and company profile of the key market players. With this large scale Arthritis Marketreport, it can also be estimated how the actions of key players are affecting the sales, import, export, revenue and CAGR values. The report also helps analyze the most appropriate method for the distribution of certain products. This market study also estimates the market status, market share, growth rate, sales volume, future trends, market drivers, market restraints, revenue generation, opportunities and challenges, risks and entry barriers, sales channels, and distributors

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AbbVie Inc.; Pfizer Inc.; Amgen Inc.; Johnson & Johnson Services, Inc.; CELGENE CORPORATION; Bristol-Myers Squibb Company; F. Hoffmann-La Roche Ltd; UCB S.A.; Gilead Sciences, Inc.; Eli Lilly and Company; Novartis AG; Sanofi; AstraZeneca; Astellas Pharma Inc.; Galapagos NV; Taisho Pharmaceutical Holdings Co., Ltd.; Boehringer Ingelheim GmbH; Swedish Orphan Biovitrum AB (publ); Regeneron Pharmaceuticals; Abiogen Pharma Spa; Merck & Co., Inc.; Kolon TissueGene, Inc.; Ampio Pharmaceuticals Inc.; GlaxoSmithKline plc among others.

Regions included:

North America (United States, Canada, and Mexico)

Europe (Germany, France, UK, Russia, and Italy)

Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)

South America (Brazil, Argentina, Colombia)

The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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A complete value chain of the global Arthritis market is presented in the research report. It is associated with the review of the downstream and upstream components of the Arthritis Market. The market is bifurcated on the basis of the categories of products and customer application segments. The market analysis demonstrates the expansion of each segment of the global Arthritis market. The research report assists the user in taking a decisive step that will be a milestone in developing and expanding their businesses in the global Arthritis market.

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Major Highlights of TOC covers:

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Chapter 4: Arthritis Market, By Region

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Arthritis Market Expected to Witness High Growth over the Forecast Period 2019 2026 - Kewaskum Statesman News Journal

ATLANTA, Sept. 14, 2020 (GLOBE NEWSWIRE) -- ATLANTA The American College of Rheumatology (ACR) will hold its first virtual Advocates for Arthritis event on Tuesday, Sept. 15, where more than 120 rheumatologists, rheumatology health professionals, and patient advocates will meet with lawmakers via video to discuss the healthcare challenges they are facing in the midst of COVID-19. During the event, advocates will urge lawmakers to adopt legislation that ensures continued delivery of accessible, safe and affordable care throughout this public health emergency and beyond.

The pandemic has altered almost every aspect of our rheumatology practices, said ACR President Ellen Gravallese, MD. It has impacted our patients lives significantly and required us to create new ways of delivering care through improved telehealth and other adaptations.

Rheumatology providers face significant resource challenges as a result of the current climate. As providers work to balance patient safety and continued access to care, many have been forced to retool their operations, move a significant portion of visits to telehealth, source their own personal protective equipment (PPE), and help patients navigate drug supply challenges while in many cases operating with less staff due to social distancing protocols, furloughs and layoffs.

Meanwhile, patients are concerned about their ability to access rheumatic care while avoiding exposure to the SARS-CoV-2 virus. A recent national patient survey conducted by the ACR found a 52 percent decline since 2019 among patients who say they are currently being treated by a rheumatology provider. Further, 66 percent of respondents reported using telehealth for rheumatology visits, with COVID-19 cited as the most common reason. While telehealth has been a welcome option for providers and patients alike, some visits such as those involving biologic therapy infusions must be conducted in-person via an office visit. Additionally, the rheumatology workforce shortage has made it increasingly difficult for patients in rural areas to find a practicing rheumatologist.

According to the latest federal estimates, 54 million Americans have a doctor-diagnosed rheumatic disease. A recent academic study suggests that number that could be as high as 91 million when taking into account symptoms reported by undiagnosed individuals. Even though as many as one-quarter to one-third of U.S. adults may be living with a rheumatic disease, there is an average of only one practicing rheumatologist for every 40,000 people, while it is estimated that the U.S. will need thousands more adult rheumatologists by 2030 to meet the challenges caused by a rapidly aging population and a fast-retiring workforce.

To address these challenges and ensure the continued delivery of high-quality care, rheumatology providers and patients are encouraging Congressional leaders to adopt the following legislative solutions:

Noting the precarious financial state of cognitive care specialists who treat complex conditions, rheumatology leaders are also urging lawmakers to support the Centers for Medicare & Medicaid Services important updates to the Physician Fee Schedule slated to take effect in January 2021. Established in concert with the American Medical Association, these updated reimbursements for complex office visits also known as Evaluation and Management (E/M) visits are critical to ensuring specialties on the front lines of treating chronic illness can continue serving patients in need.

While the rheumatology community has adapted to meet these challenges head-on, there is serious concern about the long-term sustainability of this new practice landscape without additional, targeted federal interventions and funding support from lawmakers, said Gravallese.

# # #

The American College of Rheumatology (ACR) is an international medical society representing over 7,700 rheumatologists and rheumatology health professionals with a mission to empower rheumatology professionals to excel in their specialty. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit http://www.rheumatology.org.

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Rheumatology Leaders and Patient Advocates Urge Congress to Address Care Challenges Exacerbated by COVID-19 During the Virtual Advocates for Arthritis...

Global Artificial Cartilage Implant Market: An Overview

Cartilage is a semi-solid dedicated connective tissue. It performs a wide range of roles in the human body. It is designed to bear weight, give support, torsion, and bending, and resists tension. Autologous chondrocyte implantation (ACI) is an advanced cartilage implantation method used in the new formation of the impaired articular cartilage.

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According to the National Joint Registry in the U.K., approximately 160,000 people undergo knee replacement procedures each year. The growing research and developments in relation to synthetic materials, repair procedures, and technologies like 3-D printing are expected to bring major changes to artificial cartilage implant medical procedures in the near future.

The Food and Drug Administration in the U.S. recently granted an approval for synthetic cartilage implants for arthritis. Arthritis is a common ailment among old people. Additionally, the global artificial cartilage implant market is expected to offer treatment for important body parts such as the toe, which bears a major brunt while walking and lifting the body.

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The Transparency Market Research (TMR) report provides an astute analysis of the global artificial cartilage implant market, which includes an in-depth analysis of development indicators and demand parameters that could influence the growth of this market. Main market parameters such as demand drivers and challenges of the global artificial cartilage implant market are discussed at length in this report.

Global Artificial Cartilage Implant Market: Key Trends

Currently, there are over 54.4 million adults in the U.S. who suffer from gout, rheumatoid arthritis, and common arthritis, according to Centers for Disease Control and Prevention. The number is expected to increase rapidly due to growing cases of geriatric ailments. Additionally, ailments like diabetes and lifestyle-related issues such as lack of exercise and fast foods are expected to result in more growth for the artificial cartilage implant market.

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Current cartilage implants in the market are not permanent solutions. Additionally, people who undergo surgeries experience immense pain when the connective tissue needs to be replaced. Hence, innovative technologies like durable cartilage implantation are expected to gain a prominent status in the near future. These technologies still in the pipeline of government body approvals replicate both flexibility and strength of the original tissue, and is expected to drive the global artificial cartilage implant market.

The global artificial cartilage implant market also faces some challenges in the near future. The key challenge in the artificial cartilage implant is the high cost of the replacement surgeries. Also stringent regulation procedures by the FDA are also expected hinder the market growth. However, newer synthetic materials which cause fewer complications during surgeries and increase the lifeline of the tissue are expected to drive growth.

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Global Artificial Cartilage Implant Market: Regional Outlook

Region wise, the upcoming report by TMR can offer insights into the global artificial cartilage implant market in North America, Western Europe, Asia-Pacific, Eastern Europe, Latin America, Middle East and Africa.

The artificial cartilage implant market in North America is expected to bag a notable share of the global artificial cartilage implant market. Large number of knee replacements, increasing geriatric population, and favorable healthcare insurance policies in the U.S. are the driving factors for the markets growth in North America. The artificial cartilage implant market in Asia Pacific is expected to register robust growth. The Asia Pacific market is expected to register significant CAGR growth during the forecast period. Large population, growing number of elderly people, and increasing public and private funding for research and modernization of medical care infrastructure will contribute to the growth of artificial cartilage market in Asia Pacific region.

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Global Artificial Cartilage Implant Market: Competitive Dynamics

A few of the main players in global artificial cartilage implant market are Azellon Cell Therapeutics, Biomet, Inc., DePuy, Anika Therapeutics, and CellGenix.

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Artificial Cartilage Implant Market: Durable cartilage implantation are expected to gain a prominent status in the near future - BioSpace

Action on rheumatoid arthritis urgent as new data suggest thousands affected constantly experience abuse, stigma and discrimination

A national rheumatoid arthritis (RA) campaign was launched on Monday.We R.A. Prioritygives a voice to the hundreds of thousands of adults of all ages with this often-invisible disease and challenges the potentially damaging misperceptions that persist around the condition.

Findings from new research reinforce the reality of RA in the UK today, with data suggesting many young adults with the condition regularly labelled as having an old persons disease, whilst many continue to face stigma at work and among friends and family.The We R.A. Priority campaign aims to empower those with RA to address perceptions and show how, when RA is treated as a priority, the impact can be life changing, for the individual and for society.

Over 400,000 people across the UK live with RA an incurable, systemic auto-immune condition that can cause intense pain and fatigue to those affected and, if not treated appropriately, can cause irreversible damage to joints and disability.The campaign is calling for urgent change to put a stop to the misperceptions of RA and continued social and economic impact, specifically:

RA needs a unique identity:

differentiated from other arthritic conditions which are not caused by auto-immune dysfunction

Recognition that many symptoms of RA are invisible and debilitating:

so that key audiences such as healthcare professionals, government, employers, venues, transport providers, shops, can take simple steps to better support those affected

Clare Jacklin, Chief Executiveat the National Rheumatoid Arthritis Society (NRAS) said: Over 400,000 people across the UK live with rheumatoid arthritis (RA); yet, in 2020, misunderstanding around the condition is still alarmingly high and is causing deep distress for individuals as well as a major fiscal and social cost to society.

"These are people with incredible potential and to still be in the situation where people are shouted at in the street for using disabled parking spaces because they dont look like they should or they lose their job or overlooked for career progression because of their RA, is simply unacceptable.

"Today the community is calling for urgent action. By taking just simple steps to change attitudes, we can change thousands of lives. Without this, the community could face more challenges as COVID-19 recovery plans establishes other, more recognised conditions as more important. We must act now. The reality is that those affected by RA are capable, and often inspirational people with so much to offer, as long as RA is a priority.

Data collected as part of the campaign captures feedback from over 280 people living with RA insights include:

"These are people with incredible potential and to still be in the situation where people are shouted at in the street for using disabled parking spaces because they dont look like they should or they lose their job or overlooked for career progression because of their RA, is simply unacceptable.

"Today the community is calling for urgent action. By taking just simple steps to change attitudes, we can change thousands of lives. Without this, the community could face more challenges as COVID-19 recovery plans establishes other, more recognised conditions as more important. We must act now. The reality is that those affected by RA are capable, and often inspirational people with so much to offer, as long as RA is a priority.

Data collected as part of the campaign captures feedback from over 280 people living with RA insights include:

93% of people noted that the general public fail to differentiate RA from other forms of arthritis, labelling it an older persons disease - this is despite more than half of all respondents (52%) being diagnosed under the age of 45

85% of people have experienced direct stigma as a result of RA being invisible ranging from accusations of cheating the state benefit system to being called lazy

69% of people have experienced negative attitudes when using disabled facilities as a result of their invisible symptoms with some even receiving verbal abuse

Almost half of people (47%) admitted to not feeling confident to talk to their close friends and family about their condition

One in ten people have lost a job or promotion as a result of their disease:

Previous research has shown that 60% of people with RA stop working more than 5 years earlier than they would have expected to if they had not been diagnosed with RA

More than half of respondents have lied or actively hidden their condition from friends and family, while 80% have pretended to be well enough to socialise in fear of damaging relationships or losing friendships.

Continued here:
Rheumatoid arthritis awareness week launched in the UK | ITV News - ITV News

There is a very low risk of rheumatoid arthritis worsening as a result of changing treatments due to partial or inadequate response, a new study finds. In fact, more than half of such patients treated with adalimumab who had switched to sarilumab experienced clinically meaningful improvements.

These findings were presented at the Clinical Congress of Rheumatology (CCR) East 2020 meeting.

Current guidelines recommend making any necessary therapeutic adjustments if rheumatoid arthritis patients fail to meet treatment goals or remission. Although patients may express health concerns over switching, there have been no data that assesses the association between therapy switching and disease exacerbation.

To fill this gap, a team led by Jeffrey Curtis, MD, MS, MPH, Professor of Medicine at the University of Alabama at Birmingham, performed a post-hoc analysis of the MONARCH Open-Label Extension (OLE) study and evaluated the effects of switching from adalimumab to sarilumab in patients who had partial response to treatment.

Patients who had been randomized to receive 40 mg of adalimumab during the double-blind phase were then transferred to receive 200 mg of sarilumab at the start of the extension study. Those initially receiving sarilumab continued with the regiment during open-label.

The extension study had enrolled a total 320 patients, and 155 ended up switching to the sarilumab group, with 165 maintaining sarilumab treatment.

At OLE baseline, 52% of the population had experienced partial response during the double-blind phase. The investigators noted that, as expected, partial responders were more prominent in the switch group (59%)versus the continuation group (45%).

Furthermore, the continuation group partial responders had similar but numerically lower disease activity scores at OLE baselinewith the exception of tender joint count (TJC) and swollen joint count (SJC).

For the post-hoc analysis, Curtis and team defined partial response as patients with continued moderate-to-high disease activity (Clinical Disease Activity Index [CDAI] > 10) at OLE baseline, regardless of if minimal clinically important difference (MCID) and CDAI had improved following the double-blind phase.

The MCID threshold for patients with high-disease activity at double-blind phase baseline (CDAI<22) was 12 units. The threshold for those with moderate disease activity was 6 units.

After week 24, they noted that only a few partial responders in the switch (6%) and continuation (4%) experienced a worsening of disease activity.

On the contrary, up to 57% of patients in the switch group and 43% in the continuation group experienced improvements in disease activity.

There was no observed change of disease activity in 37% and 53% of the switch and continuation cohorts, respectively.

And finally, the team reported that between OLE baseline and week 24, the mean changes in efficacy parameters and patient reported outcomes had numerically increased. The only exception was SJC28.

A small risk of worsening with the substantial likelihood of meaningful improvement may help alleviate patient fears of worsening when considering a switch to an alternative therapy, such as sarilumab, they concluded.

The study, Low Probability of Clinical Worsening Following Switching Biologic Disease-Modifying Antirheumatic Drug in Patients with Rheumatoid Arthritis and Partial Response to Adalimumab, was presented at CCR East.

Read more:
Switching Antirheumatic Therapies Has Low Risk of Clinical Worsening - MD Magazine

The continuing spread of Coronavirus (COVID-19) amongst major global economies has become an important factor of concern for import and export activities. Learn how companies in the Psoriatic Arthritis Therapeutics market are responding to the Coronavirus crisis by gaining efficacy in alternative strategies that are stabilizing various business activities. Browse through our latest research analysis on COVID-19 and its impact over the global market landscape.

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The study reveals that the global Psoriatic Arthritis Therapeutics market is projected to reach a market value of ~US$XX by the end of 20XX and grow at a CAGR of ~XX% during the assessment period. Further, a qualitative and quantitative analysis of the Psoriatic Arthritis Therapeutics market based on data collected from various credible sources in the market value chain is included in the report along with relevant tables, graphs, and figures.

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Value of Psoriatic Arthritis Therapeutics Market Predicted to Surpass US$ by the of 2017 2025 - The Daily Chronicle

Global Canine Arthritis Treatment Market research report presents a comprehensive overview of market size, share, evolution, trends, and forecast, and growth opportunities of Canine Arthritis Treatment market by product type, application, key manufacturers and key regions and countries. This report offers comprehensive analysis on global Canine Arthritis Treatment market along with, market trends, drivers, and restraints of the Canine Arthritis Treatment market. In-depth study of market size with data Tables, Bar & Pie Charts, and Graphs & Statistics which helps easy to understand detailed breakdown of market.

Note: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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the following market information:Global Canine Arthritis Treatment Market Size, 2019-2021, and 2020 (quarterly data), (US$ Million)Global Canine Arthritis Treatment Market Size by Type and by Application, 2019-2021, and 2020 (quarterly data), (US$ Million)Global Canine Arthritis Treatment Market Size by Region (and Key Countries), 2019-2021, and 2020 (quarterly data), (US$ Million)Global Canine Arthritis Treatment Market Size by Company, 2019- 2020 (quarterly data), (US$ Million)

Key market playersMajor competitors identified in this market include Elanco (Eli Lilly and Company), Boehringer Ingelheim, Zoetis Inc, Vetoquinol S.A., Bayer AG, Aratana Therapeutics Inc, Norbrook Laboratories Limited, VetStem Biopharma, Dechra Pharmaceuticals Plc, etc.

Based on the Region:Asia-Pacific (China, Japan, South Korea, India and ASEAN)North America (US and Canada)Europe (Germany, France, UK and Italy)Rest of World (Latin America, Middle East & Africa)

Based on the Type:Non-Steroidal Anti-Inflammatory DrugsOpioids

Based on the Application:Veterinary Hospitals and ClinicsDrug StoresE-commerce

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Canine Arthritis Treatment Market : Facts, Figures and Analytical Insights, 2019 to 2025 - The Daily Chronicle

Obesity and metabolic syndrome

Adiposity obesity, particularly when it begins in childhood and late adolescence, was identified as leading to a 2-fold risk of developing MS in one study, according to Ruth Ann Marrie, MD, PhD, FRCPC, director of the Multiple Sclerosis Clinic at the University of Manitoba. Central obesity, or visceral adipose fatty deposits in the abdominal area, is a key component of metabolic syndrome, a cluster of abnormalities that includes hypertension, dyslipidemia, and insulin resistance and is linked to a higher risk of cardiac disease and diabetes.

In the Nurses Health Study, which examined risk factors for chronic disease, women with a body mass index (BMI) of 30 or more had a 2-fold increased risk of subsequently developing MS. And a study using data from the Copenhagen School Health Records Register found that children aged 7 to 13 years with a BMI equivalent to 30 in adults had an increased risk of developing MS later in life.

Obesity is more common even before MS diagnosis, Marrie said. In an effort to look at other aspects of metabolic syndrome, researchers used Canadian claims data of about 20,000 individuals with newly diagnosed MS and found that by the time of diagnosis, more than 15% had hypertension and nearly 10% had dyslipidemia.

There is also evidence that obesity and components of metabolic syndrome are associated with longer diagnostic delays, greater disability at diagnosis, as well as an increased relapse rate and accelerated disability progression. One key question she said, is whether treating metabolic syndrome might improve MS outcomes and multiple sclerosis.

In one small, nonrandomized cohort study of 50 individuals with MS, obesity, and metabolic syndrome, they were treated either with metformin or pioglitazone, or they declined treatment.

Before treatment, researchers measured the number of newer enlarging T2 lesions in the 24-month period before intervention as well as gadolinium-enhancing lesions; all 3 groups looked similar.

After treatment with either metformin or pioglitazone, the number of newer T2 lesions as well as gadolinium-enhancing lesions dropped over 24 months. Patients who declined treatment did not see a decrease.

I think the growing body of evidence suggests that clinical trials are needed to really test whether treating obesity and metabolic syndrome may improve outcomes in MS and to test whether we need to be using different strategies for managing disease-modifying therapy, including dosing in individuals who are obese or extremely obese with multiple sclerosis, Marrie said.

Smoking and genetics

Another presentation focused on the interactions between modifiable risk factorsnamely smokingand genetics.

People with a genetic susceptibility to the disease may be at a substantially increased risk of developing MS if youre exposed to certain environmental factors, said Anna Hedstrm, MD, PhD, from the Karolinska Institute Stockholm, Sweden in the Department of Clinical Neuroscience.

Smoking and the chemicals from tobacco creates a cascade of problems, including systemic inflammation, local inflammation in the lungs, oxidative stress, damaged neural tissue, and epigenetic changes.

Smoking increases the risk of MS by about 50%, she said, with men more affected than women; in addition, there is also a dose response relationship between the accumulated dose of smoking and the risk of developing the disease.

In 2005, the Karolinska Institute began a study called the Epidemiological Investigation of Multiple Sclerosis, which uses the countrys national MS registry. As an ongoing study, it now includes 9000 cases and 12,000 matched controls.

In 2011, Hedstrm and colleagues published a study that found a significant interaction between 2 genetic risk factors and smoking: HL ADRB1*15, the key genetic risk factor for MS, and HLA A*02, the absence of which carries a reduced risk of MS. The research looked at the interaction of these genes in both smokers and non-smokes.

Smokers with both genes had an odds ratio (OR) of 13.5 (8.1-22.6) for MS, compared with nonsmokers with the same makeup.

Compared with non-smokers with neither of the genetic risk factors, the OR for smokers without genetic risk was 1.4 (0.9-2.1); the OR for non-smokers with both genetic risk factors was 4.9 (3.6-6.6).

Among those with both genetic risk factors, smoking increased the risk by a factor of 2.8 in comparison with a factor of 1.4 among those without the genetic risk factors.

Passive smoking (ie, never smokers exposed to second-hand smoke) also increases MS risk (OR 1.3-1.6) and the risk increases along with the length of exposure, she said.

Similarly, exposure to organic solvents, she said, also raises the rise of MS in people with the same genetic profile.

MS and Epstein-Barr virus (EBV) infection

No virus has been discovered as a cause of MS, but the hypothesis that a virus may be involved in MS has been around for some time, said Kassandra Munger, ScD, of the Department of Nutrition in the Harvard TH Chan School of Public Health. Current knowledge, she said, points to Epstein-Barr.

From environmental risk factor perspective, MS is likely a rare complication of Epstein-Barr virus infection, with risk further modified by inadequate vitamin D levels, being overweight or obese in early life and cigarette smoking, she said.

Early studies attempting to look at the issue through antibody testing could not determine if EBV infection proceeded MS or if it was a complication.

Using blood samples collected by the Department of Defense of US military members, Munger and colleagues found preliminary evidence that EBV infection does happen before MS. They identified 305 MS cases and 610 matched controls. In cases where serum samples were collected before the onset of MS symptoms and measured EBV titers, they found that 38 were EBV negative at the time they went on active duty. During follow up, up until MS onset, 20 of the 38 became EBV positive. Eighteen remained EBV negative and did not develop MS.

This is a preliminary finding that needs to be replicated in a larger study, she said.

References

Hedstrm AK, Sundqvist E,Brnhielm M,et al. Smoking and two human leukocyte antigen genes interact to increase the risk for multiple sclerosis. Brain.2011;134(3):653-64.doi:10.1093/brain/awq371

Excerpt from:
Unraveling the Impact of Lifestyle, Genetics on MS - AJMC.com Managed Markets Network

In recent years, a field that has traditionally relied on fossil discoveries has acquired helpful new tools: genomics and ancient DNA techniques. Armed with this combination of approaches, researchers have begun to excavate our species early evolution, hinting at a far more complex past than was previously appreciatedone rich in diversity, migration, and possibly even interbreeding with other hominin species in Africa.

To piece together that story, we need information from multiple different fields of study, remarks Eleanor Scerri, an archaeologist at the Max Planck Institute for the Science of Human History in Jena, Germany. No single one is really going to have all the answersnot genetics, not archaeology, not the fossils, because all of these areas have challenges and limitations.

[I]t was the advent of genetic research that showed unequivocally that populations outside of Africa descended from a single population in Africa. But the story had a twist: intwogroundbreakingstudiespublished in 2014, researchers compared ancient DNA extracted from Neanderthal bones and compared it with modern-day people, and found that 2 percent of the average European genome is Neanderthal in origin. Our species originated in Africa, but interbred with hominins outside of it.

These findings, and many since, have highlighted the power of genetics in resolving questions about human ancestry that fossils alone cannot.

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When 'bones and stones' are not enough: Genetics fills in the blanks in the story of human evolution - Genetic Literacy Project

Acclinate Genetics Co-Founders Tiffany Jordan-Whitlow and Del Smith

Huntsville, Alabama, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Racial and ethnic minorities make up 40 percent of the U.S. population. But in clinical trials, minorities often account for as little as two percent of participants. As a result, there are many examples of commonly prescribed pharmaceuticals that are less effective or have negative side effects due to a persons race and ethnicity.

This is a problem that needs to be addressed, saysDel Smith, co-founder and Chief Executive Officer of Acclinate Genetics. It only exacerbates the health inequalities were already dealing with in America and around the world. We believe that diversifying genomic research and clinical trials to include more representation and diversity increases knowledge about health issues and makes a difference in personalized healthcare for all.

Smith and co-founder of Acclinate Genetics Tiffany Jordan-Whitlow have both been personally impacted by the lack of minority representation in medicine. Their company helps biopharmaceutical companies and contract research organizations increase minority and ethnic participation in research and trials. With a platform that protects privacy, the company utilizes machine learning and predictive analytics to ensure selection of more diverse participants. Acclinate creates value by decreasing the overall cost of drug development, increasing the speed of drug approval, integrating with virtual clinical trials and contributing to the discovery of new drugs.

Acclinate Genetics recently gained backing from Bronze Valley, a Birmingham-based early stage venture investment platform dedicated to supporting high growth, minority-owned businesses. The partnership makes Acclinate Genetics the first bio company to join Bronze Valleys portfolio.

We are proud to announce our partnership with Bronze Valley, and we are grateful for their support and confidence in Acclinate Genetics position for future growth. says Jordan-Whitlow. With forward momentum, Acclinate remains focused on helping diverse individuals make informed decisions about genomic research, clinical trial participation and their overall health.

Addressing longstanding inequities in research and clinical trials also presents business opportunities. Currently, the clinical trial patient recruitment market is a $3.4 billion business, a figure projected to grow to $5.3 billion by 2030.

Acclinates Smith says that he and Jordan-Whitlow have followed the philosophy of applying sound business principles to making positive social impacts. As Acclinate continues to grow and scale, the company seeks investors and partners, who honor that same philosophy, to come alongside them.

About Acclinate Genetics

Acclinate Genetics is a Huntsville-based startup working to help biopharmaceutical companies and contract research organizations increase the representation and diversity of their genomic research and clinical trials. Founded by Del Smith and Tiffany Jordan-Whitlow, the trusted digital health company has a mission to educate and engage diverse individuals to make informed decisions about their health. For more information about Acclinate Genetics, visit http://www.acclinategenetics.com.

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Minority-owned biotech startup Acclinate Genetics secures investment to expand diversity in clinical trials - GlobeNewswire

TEMPLE CITY, Calif., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics, Inc. (NASDAQ: FLGT) (Fulgent Genetics or the company), a technology company providing comprehensive testing solutions through its scalable technology platform, today announced a new partnership with the State of Utah for COVID-19 testing.

Through a competitive bidding process, the Utah Department of Health selected Fulgent Genetics to utilize the companys FDA EUA-approved RT-PCR test for its Test Utah COVID-19 testing initiative. This initiative was developed to increase availability of COVID-19 testing solutions for residents across the state of Utah to help stem the spread of COVID-19. Fulgents RT-PCR test is being administered at a number of fixed sites and mobile units in select counties across the state, with the potential to expand as the program grows. Samples are collected on-site and processed at Fulgents lab in Temple City, California and results are delivered to patients within an average of 24 hours of sample receipt.

We are pleased to be selected as a partner by the Utah Department of Health for their Test Utah initiative, which is making COVID-19 testing more readily available for residents of Utah, commented Brandon Perthuis, Chief Commercial Officer of Fulgent Genetics. The State of Utah joins the growing list of municipalities, healthcare providers and organizations that have selected Fulgents RT-PCR test for their COVID-19 testing needs. Our rapid turnaround time, reliable testing solutions combined with our user-friendly platforms and applications continue to be reasons why Fulgent is selected as a testing partner in these competitive situations.

As we look to stop the spread of COVID-19 and save lives across the state of Utah, we are pleased to be working with Fulgent Genetics as part of our Test Utah initiative to offer our residents a convenient and reliable testing solution for COVID-19, said Utah Governor Gary Herbert. The goal of our Test Utah initiative is to dramatically increase the rate of COVID-19 testing in the state so residents can have better access to testing and help stem the spread of COVID-19, so we can get back to normal as quickly as possible. We are thankful to have Fulgent as a partner to offer reliable and timely COVID-19 testing solutions.

For more information on the State of Utahs Test Utah program, please visit http://www.testutah.com.

About Fulgent Genetics

Fulgent Genetics proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy and competitive turnaround times. Combining next generation sequencing (NGS) with its technology platform, the company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. In 2019, the company launched its first patient-initiated product, Picture Genetics, a new line of at-home screening tests that combines the companys advanced NGS solutions with actionable results and genetic counseling options for individuals. Since March 2020, the company has commercially launched several tests for the detection of SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19), including NGS and reverse transcription polymerase chain reaction (RT-PCR) - based tests. The company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the RT-PCR-based tests for the detection of SARS-CoV-2 using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs) and for the at-home testing service through Picture Genetics. A cornerstone of the companys business is its ability to provide expansive options and flexibility for all clients unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated lab services.

About Picture Genetics

Through its Picture Genetics platform launched in 2019, Fulgent Genetics offers consumers direct access to its advanced genetic testing and analytics capabilities from the ease and comfort of home, at an affordable price point. The Picture Genetics platform provides a holistic approach to at-home genetic screening by including oversight from independent physicians as well as genetic counseling options to complement Fulgent Genetics comprehensive genetic testing analysis. The Picture Genetics platform currently offers multiple tests, providing medically actionable, clinical-level results with professional medical follow-up in one easy process. Visit http://www.picturegenetics.com for more information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: managements beliefs, judgments and estimates regarding Fulgents testing solutions, including its technology platforms and RT-PCR testing solution; the companys identification and evaluation of opportunities and its ability to capitalize on opportunities to grow its business; and its expected lab capacity and results turnaround times.

Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the companys future performance, and they are based on managements current assumptions, expectations and beliefs concerning future developments and their potential effect on the companys business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its tests and the pandemics effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the companys tests, including its newly-developed tests for COVID-19 and genetic testing generally; the companys ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets, including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the companys ability to maintain the low internal costs of its business model, particularly as the company makes investments across its business; the companys ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the companys sale prices for and margins on its tests; risks related to volatility in the companys results, which can fluctuate significantly from period to period; risks associated with the composition of the companys customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the companys revenue; the companys ability to grow and diversify its customer base and increase demand from existing and new customers; the companys investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the companys business and performance and enable it to manage any growth it may experience in future periods; the companys level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the companys level of success in establishing and obtaining the intended benefits from partnerships, joint ventures or other relationships; the companys compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the companys international operations; the companys ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and the company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

The companys reports filed with the U.S. Securities and Exchange Commission (SEC), including its annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020 and the other reports it files from time to time, including subsequently filed quarterly and current reports, are made available on the companys website upon their filing with the SEC. These reports contain more information about the company, its business and the risks affecting its business.

Investor Relations Contact:The Blueshirt GroupNicole Borsje, 415-217-2633; nborsje@blueshirtgroup.com

Media Contact:The Blueshirt GroupJeff Fox, 415-828-8298, jeff@blueshirtgroup.com

Originally posted here:
Fulgent Genetics to Provide COVID-19 Testing Solutions for the State of Utah - GlobeNewswire

With the focus of personal privacy increasing, it is unsurprising that additional laws are being proposed to increase privacy rights, including the California Privacy Rights Act initiative on the ballot this upcoming November. More immediately, the California legislature passed, and Governor Newsom signed, the Genetic Information Privacy Act ("GIPA"). GIPA specifically targets biometric information, due to the increase of genetic tracing services, like 23andMe and Ancestry.com. This law pertains to adding more protections to genetic privacy. Many questions arise following the passage of GIPA, such as what businesses are affected? What, if any, penalties or causes of action exist under this new law? How does this law work alongside the CCPA?

WHAT IS IN THE LAW?

The law requires notices and actual, express consent from consumers for direct-to-consumer genetic testing companies, and any other company that collects, uses, maintains, or discloses information collected from biometric samples, or from any other element concerning genetic material (i.e. genes). Regarding the express consent provision in particular, this requires that consent is provided for: (1) the use of data through the genetic testing product being provided, for those specific purposes; (2) the storage of the consumer's biometric sample after testing is complete; (3) each use of the genetic data or sample beyond what was originally intended; (4) each transfer or disclosure to a third party other than service providers, including that third party's name; and (5) any marketing based on the genetic data. In essence, unless a consumer explicitly opts in, these companies cannot store, use, or market based on the genetic information.

WHAT ARE THE PENALTIES?

The penalties for not following GIPA are akin to those for the CCPA, with a $1,000 fine, plus court costs for negligent violations, and $10,000 for willful violations. Furthermore, unlike the CCPA, this law does include a private right of action, as it allows a person who has suffered injury in fact, or has lost money or property, as a result of a violation. In essence, this increases the damages for a company which fails to reasonably secure genetic information from data breaches, though plaintiffs may have difficulty showing that money or property was lost due to the exposure of their genetic information, unlike the CCPA, which implements statutory damages just for the breach occurring.

HOW DOES THIS INTERACT WITH THE CCPA?

Regarding the CCPA, both laws will be in effect, and these companies would be obliged to provide additional notices in addition to those required under the CCPA. Furthermore, they both would protect the same information, as the CCPA does protect biometric data, which would largely overlap with the protections of the genetic information under GIPA. GIPA and the CCPA also both require that reasonable security is utilized to protect the consumer's genetic information. However, GIPA also goes further, in requiring that reasonable security is taken to prevent unauthorized destruction as well. Furthermore, it is noteworthy that GIPA relies on the same "reasonable security" language as the CCPA.

Ultimately, GIPA places stricter requirements on genetic testing companies, such that they will have to be more transparent with consumers, and it may serve as a model for future changes to the CCPA. For instance, GIPA will require more click-wrap agreements and additional changes to items like Terms of Use agreements, to ensure that users agree to each use of the genetic data.

WHAT SHOULD A BUSINESS DO?

For businesses subject to GIPA, reviewing, adjusting and implementing additional consent measures to a website should be paramount, as well as reviewing and updating the privacy policy once more in order to make sure that all notices are present. Furthermore, reviewing current security measures and processes is equally important, due to the more stringent requirements on the restrictions against unauthorized destruction of information.

Ultimately, the biggest change to genetic testing companies under GIPA may be an increased reliance on consumer accounts permitting consumers to login, see, and manage their data in order to give the individualized consents, an increased reliance on click-wrap agreements requiring that consumers scroll through, read, and accept actions by the company before the company takes them, or a combination of the two.

For other businesses, GIPA provides an opportunity to implement and utilize stricter privacy guidelines, and implement them as a potential benefit to consumers, as GIPA requirements largely surpass those under the CCPA.

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California Enacts the Genetic Privacy Information Act | Newmeyer Dillion - JD Supra

The Borofka family celebrated their son JTs second birthday by throwing him a drive-by birthday parade Sunday. JT Borofka has already achieved more obstacles than most kids his age. Suffering with Triosephosphate Isomerase Deficiency, or TPI, this rare genetic disease has been challenging to say the least.Hes weaker, but at the moment hes stable, explained JTs mom, Tara Borofka. We still work with physical therapy. Hes got a little bit better head control. JT is extremely strong and doesnt give up. If theres a toy that is a little too far, he will reach for it even if he has to fall over.And just like JT, his doctors in Pittsburgh arent giving up either.The next step is to go through all the compounds they have found that could possibly be a cure, explained Jason Borofka, JTs dad.Michael Palladino, Professor of Pharmacology and Chemical Biology at the University of Pittsburgh School of Medicine said those compounds will need to be tested.We can test them first in a mouse model, explained Palladino. If you can show that not only did it work in JTs cell. We have JTs cells to test these drugs in, but when we put it in an animal model with his same mutations, that that animal model improves as well.The process can take anywhere from 8 months to 3 years, but while the Borofkas wait for the cure, theyre focusing on celebrating another year with their son.If you would like more information about JT and the researching being done in Pittsburgh, you can visit their website.

The Borofka family celebrated their son JTs second birthday by throwing him a drive-by birthday parade Sunday. JT Borofka has already achieved more obstacles than most kids his age. Suffering with Triosephosphate Isomerase Deficiency, or TPI, this rare genetic disease has been challenging to say the least.

Hes weaker, but at the moment hes stable, explained JTs mom, Tara Borofka. We still work with physical therapy. Hes got a little bit better head control. JT is extremely strong and doesnt give up. If theres a toy that is a little too far, he will reach for it even if he has to fall over.

And just like JT, his doctors in Pittsburgh arent giving up either.

The next step is to go through all the compounds they have found that could possibly be a cure, explained Jason Borofka, JTs dad.

Michael Palladino, Professor of Pharmacology and Chemical Biology at the University of Pittsburgh School of Medicine said those compounds will need to be tested.

We can test them first in a mouse model, explained Palladino. If you can show that not only did it work in JTs cell. We have JTs cells to test these drugs in, but when we put it in an animal model with his same mutations, that that animal model improves as well.

The process can take anywhere from 8 months to 3 years, but while the Borofkas wait for the cure, theyre focusing on celebrating another year with their son.

If you would like more information about JT and the researching being done in Pittsburgh, you can visit their website.

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The Borofka family celebrates another year with their son, who is suffering from a rare genetic disease - KSBW Monterey

MedicalResearch.com Interview with:

Dr Mario FalchiHead of Bioinformatics for the School of Life Course SciencesDepartment of Twin Research & Genetic EpidemiologyKings College London

MedicalResearch.com: What is the background for this study?

Response: The relationship between sun exposure and health is a double-edged sword, on one side there is the beneficial effect of vitamin D production and on the other the increased risk of skin cancer, depending on length and frequency of exposure, and on the individual skin type.

Despite public health campaigns, changing sun-seeking behaviour seems to be challenging for some people, even for those with a familial or personal history of skin cancer. Previous investigations have suggested that exposure to UV could be addictive.

MedicalResearch.com: What are the main findings?

Response: We investigated the sun seeking behaviour of 2,500 twins from the TwinsUK cohort, finding that identical twins tend to share a more similar attitude towards sun exposure compared to fraternal twins. Sun seeking seems to be heritable and significantly influenced by genetics. To identify the genes involved, we performed a genome-wide association study of sun seeking behaviour in 260,000 volunteers from the UK Biobank and the US Nurses Health Studies and Health Professionals Follow-up Study, which highlighted five significantly-associated genetic loci. These loci are enriched for genes expressed in the central nervous system, and that have been previously associated with behavioural traits, cognitive function, and addiction. Interestingly, one of these genes has also recently been associated with vitamin D levels

MedicalResearch.com: What should readers take away from your report?

Response: Sun seeking behaviour is influenced by genes involved in neuropsychological traits and addiction. This should be taken into account to improve the efficiency of public health campaigns aimed at reducing sun exposure and incidence of skin cancer.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Further investigations aimed at understanding the mechanisms of addiction more generally, and the biological pathways involved will help in identifying potential drug targets to tackle and help controlling a number of risky behaviours that have a negative impact on public health.

Citation:

Sanna Marianna, Li Xin, Visconti Alessia, Freidin Maxim B, Sacco Chiara, Ribero Simone, Hysi Pirro, Bataille Veronique, Han Jiali, Falchi Mario.Looking for Sunshine: Genetic Predisposition to Sun-Seeking in 265,000 Individuals of European Ancestry.Journal of Investigative Dermatology, 2020; DOI:10.1016/j.jid.2020.08.014

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Craving the Sun? Twin Study Finds It May Be Genetic - MedicalResearch.com

Sept. 14, 2020 10:45 UTC

BOTHELL, Wash. & KENILWORTH, N.J.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced two new strategic oncology collaborations.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200914005237/en/

The companies will globally develop and commercialize Seattle Genetics ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors. The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Under the terms of the agreement, Seattle Genetics will receive a $600 million upfront payment and Merck will make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6 billion.

Separately, Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics will receive $125 million from Merck as an upfront payment and is eligible for progress-dependent milestones of up to $65 million.

Collaborating with Merck on ladiratuzumab vedotin will allow us to accelerate and broaden its development program in breast cancer and other solid tumors, including in combination with Mercks KEYTRUDA, while also positioning us to leverage our U.S. and European commercial operations, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The strategic collaboration for TUKYSA will help us reach more patients globally and benefit from the established commercial strength of one of the worlds premier pharmaceutical companies.

These two strategic collaborations will enable us to further diversify Mercks broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible, said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. We look forward to working with the team at Seattle Genetics to advance the clinical program for ladiratuzumab vedotin, which has shown compelling signals of efficacy in early studies, and to bring TUKYSA to even more patients with cancer around the world.

Ladiratuzumab Vedotin Collaboration Details

Under the terms of the agreement, Seattle Genetics and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck will pay Seattle Genetics $600 million upfront and make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics will be eligible to receive up to $2.6 billion in milestone payments, including $850 million in development milestones and $1.75 billion in sales milestones.

The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide. The companies will co-commercialize in the U.S. and Europe. Seattle Genetics will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in Europe and in countries outside the U.S. and Canada, and will record sales in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seattle Genetics is eligible to receive up to $4.2 billion.

The closing of the equity investment is contingent on completion of review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

TUKYSA Collaboration Details

Under the terms of the agreement, Merck has been granted exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics retains commercial rights and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial.

Merck will also co-fund a portion of the TUKYSA global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan. Seattle Genetics will continue to lead ongoing TUKYSA global development planning and operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territory.

Seattle Genetics will receive from Merck $125 million as an upfront payment and is eligible to receive progress-dependent milestones of up to $65 million. Seattle Genetics will also receive $85 million in prepaid research and development payments to be applied to Mercks global development funding obligations. In addition, Seattle Genetics would receive tiered royalties on sales of TUKYSA in Mercks territory.

The financial impact of these collaborations is not included in Seattle Genetics 2020 guidance.

Seattle Genetics Conference Call Details

Seattle Genetics management will host a conference call to discuss these collaborations today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Seattle Genetics website at http://www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or +1 412-717-9224 (international). The conference ID is 10147850.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1. Most metastatic breast cancers express LIV-1, which also has been detected in several other cancers, including lung, head and neck, esophageal and gastric. Ladiratuzumab vedotin utilizes Seattle Genetics proprietary ADC technology and consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker. This novel ADC is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response by induction of immunogenic cell death.

About TUKYSA (tucatinib)

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth. TUKYSA in combination with trastuzumab and capecitabine was approved by the U.S. Food and Drug Administration (FDA) in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. In addition, TUKYSA received approval in Canada, Singapore, Australia and Switzerland under the Project Orbis initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners. A marketing application is under review in the European Union.

TUKYSA is being evaluated in several ongoing clinical trials and additional studies are planned. Current trials include the following:

For additional information, visit http://www.clinicaltrials.gov.

TUKYSA Important Safety Information

Warnings and Precautions

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Use in Specific Populations

For more information, please see the full Prescribing Information for TUKYSA here.

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 1,200 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

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.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of 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 confirmatory trials.

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 head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of 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.

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. 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 confirmatory trials. 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 [combined positive score (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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

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 (mut/Mb)] 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.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes 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.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

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BOSTON & BORDENTOWN, N.J.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Caelum Biosciences today announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival.

In AL amyloidosis, misfolded amyloid proteins can build up in many organs throughout the body, including the heart and kidneys, causing significant damage to these organs and impairing their function. While current treatments address the bone marrow disorder that creates the misfolded amyloid proteins, there are no approved therapies for the significant organ damage the disease causes, said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion. CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from these organs. Data from Phase 1 studies suggest that this treatment approach may improve organ function and long-term survival. We look forward to investigating this further in the Phase 3 clinical program.

AL amyloidosis is particularly devastating when it affects the heart, with median survival in these patients of less than one year following diagnosis, said Michael Spector, President and Chief Executive Officer of Caelum. Long-term survival data from AL amyloidosis patients treated with CAEL-101 in the Phase 1a/1b study showed that 78 percent were still alive after a median follow-up time of more than three years. We recognize the urgent need for new treatments that address the organ damage caused by AL amyloidosis and are working together with the AL amyloidosis community and Alexion to advance the Phase 3 clinical program as quickly as possible.

About the CARES Phase 3 Clinical Program

The CARES clinical program consists of two parallel double-blind, randomized, event-driven global Phase 3 studies, which are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and nave to standard of care (SoC) treatment (cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy). One study is enrolling approximately 260 patients with Mayo stage IIIa disease and one study is enrolling approximately 110 patients with Mayo stage IIIb disease. The studies will be conducted at approximately 70 sites across North America, the United Kingdom, Europe, Israel, Japan, and Australia.

In each study, participants are being randomized in a 2:1 ratio to receive either CAEL-101 plus SoC or placebo plus SoC once weekly for four weeks. This will be followed by a maintenance dose administered every two weeks until the last patient enrolled completes at least 50 weeks of treatment. Patients will continue follow-up visits every 12 weeks.

The primary study objectives are overall survival and the safety and tolerability of CAEL-101. Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures (Kansas City Cardiomyopathy Questionnaire Overall Score & Short Form 36 version 2 Physical Component Score) and cardiac improvement (Global Longitudinal Strain, or GLS).

Phase 2 Study Results

The Phase 2 open-label dose escalation study was conducted to investigate higher doses of CAEL-101 than had been evaluated in Phase 1 studies with a primary objective to identify the best dose to advance into Phase 3 development. The study evaluated the safety and tolerability of CAEL-101 in 13 AL amyloidosis patients at three study sites who received up to 1000 mg/m2 of CAEL-101 (two times the Phase 1 dose) administered in combination with SoC treatment. The study met its primary objectives, supporting the safety and tolerability of CAEL-101 and the selection of the 1000 mg/m2 dose for the Phase 3 study.

Phase 1a/1b Long-Term Follow-Up Results Presented at ISA 2020

As previously reported, the Phase 1a/1b study of CAEL-101 was the first clinical trial to demonstrate improvement in cardiac function via GLS after treatment with an amyloid fibril targeted therapy in AL amyloidosis patients with amyloid cardiac involvement. New long-term follow-up data from the Phase 1a/1b study will be presented at the virtual International Symposium on Amyloidosis (ISA), September 14 to 18, 2020, in the poster titled, Long term follow-up of patients with AL amyloidosis treated on a phase 1 study of Anti-Amyloid Monoclonal Antibody CAEL-101 (Abstract #342, Divaya Bhutani, M.D., et. al, Columbia University Medical Center). These data demonstrate 78 percent survival (15/19) at a median follow-up of more than three years (37 months) in AL amyloidosis patients treated with CAEL-101 as well as durable organ response among evaluable patients, further supporting the advancement of CAEL-101 into Phase 3 development.

About CAEL-101

CAEL-101 is a first-in-class monoclonal antibody (mAb) designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes. In a Phase 1a/1b study, CAEL-101 demonstrated improved organ function, including cardiac and renal function, in 27 patients with relapsed and refractory AL amyloidosis who had previously not had an organ response to standard of care therapy. CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a therapy for patients with AL amyloidosis.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded immunoglobulin light chains produced by plasma cells aggregate and form fibrils that deposit in tissues and organs. This deposition can cause widespread and progressive organ damage and high mortality rates, with death most frequently occurring as a result of cardiac failure. Current standard of care includes plasma cell directed chemotherapy and autologous stem cell transplant, but these therapies do not address the organ dysfunction caused by amyloid deposition, and up to 80 percent of patients are ineligible for transplant.

AL amyloidosis is a rare disease but is the most common form of amyloidosis. There are approximately 22,000 patients across the United States, France, Germany, Italy, Spain and the United Kingdom. AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis.

About Alexion

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: http://www.alexion.com.

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About Caelum Biosciences

Caelum Biosciences, Inc. (Caelum) is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Caelums lead asset, CAEL-101, is a novel antibody for the treatment of patients with amyloid light chain (AL) amyloidosis. In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data. Caelum was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.caelumbio.com.

Forward-Looking Statement

This press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Alexion and Caelum, including statements related to: the safety and efficacy CAEL-101 as a treatment for AL amyloidosis; CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from the heart, kidney and other organs; data from the Phase 1 studies suggest that the treatment approach may improve organ function and long-term survival and enrollment of the Phase 3 trials. Forward-looking statements are subject to factors that may cause Alexion's and Caelums results and plans to differ materially from those expected by these forward looking statements, including for example: the anticipated safety profile and the benefits of the CAEL-101 may not be realized (and the results of the clinical trials may not be indicative of future results); the inability to enroll and complete the Phase 3 trial; results of clinical trials may not be sufficient to satisfy regulatory authorities; results in clinical trials may not be indicative of results from later stage or larger clinical trials (or in broader patient populations); the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to discontinue sales of the product (or halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates); the severity of the impact of the COVID-19 pandemic on Alexions or Caelums business, including on commercial and clinical development programs; unexpected delays in clinical trials; unexpected concerns regarding products and product candidates that may arise from additional data or analysis obtained during clinical trials or obtained once used by patients following product approval; future product improvements may not be realized due to expense or feasibility or other factors; delays (expected or unexpected) in the time it takes regulatory agencies to review and make determinations on applications for the marketing approval of our products; inability to timely submit (or failure to submit) future applications for regulatory approval for our products and product candidates; inability to timely initiate (or failure to initiate) and complete future clinical trials due to safety issues, IRB decisions, CMC-related issues, expense or unfavorable results from earlier trials (among other reasons); future competition from biosimilars and novel products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by regulatory agencies regarding our products and product candidates; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us; the risk that third party payors (including governmental agencies) will not reimburse for the use of our products at acceptable rates or at all; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; adverse impacts on supply chain, clinical trials, manufacturing operations, financial results, liquidity, hospitals, pharmacies and health care systems from natural disasters and global pandemics, including COVID-19 and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended June 30, 2020 and in their other filings with the SEC. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

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Alexion and Caelum Biosciences Announce Start of Phase 3 Studies of CAEL-101 in AL Amyloidosis - Business Wire