StemCell Therapy

Study design and period

The trial is a single center, two-armed phase III study. The trial has been registered at http://www.clinicaltrials.gov (NCT03201926). Patients will be recruited by the Pancreatobiliary Cancer Clinic, Gangnam Severance Hospital, Yonsei University College of Medicine. The expected total duration of patient accrual is 2years and 6months and the follow-up period is 6months.

The primary endpoint is to evaluate body cell mass index at 2months postoperatively. Secondary endpoints include other body composition changes as well as nutrition index and immune function.

Patients scheduled for surgery with pancreatobiliary disease and liver cancer (HCC, CCC, and metastatic liver cancer)

Karnofsky performance status 70

Patients who provide informed consent

Patients who underwent palliative surgery

Patients with uncontrolled preoperative conditions

Previous history of surgery affecting nutritional status (ex, gastrectomy, colectomy, etc)

Pregnant and lactating women

Patients with an allergy to mealworms

The output of the sample size will be based on an independent two-sample t test. It is expected that there will be a difference in body cell mass between the standard meal group (control) and the group ingesting the mealworms. Assuming an alpha value of 0.05 and 1- (power) of 0.8, 75 samples will need to be obtained for each group; considering the dropout rate of 10%, 84 samples will need to be obtained for each group. The total of the two groups is 168. The primary endpoint will be the number of subjects and body cell mass. A comparison will then be made between the two groups at 2months. A subgroup analysis of pancreatobiliary and liver disease will also be performed as a secondary endpoint. Patients with pancreatobiliary and liver disease in our clinic have a 2:1 ratio. Therefore, the 168 patients were divided into two groups: one with 112 patients and the other with 56 patients. Patients with pancreaticobiliary disease (Group A & B) and liver (Group C) disease were assigned through stratified randomization. Pancreatobiliary disease group is divided into enteral feeding group(Group A) and non enteral feeding group.(Group B).

All patients who are potential candidates for hepatopancreatobiliary surgery will undergo a standard evaluation that will include contrast-enhanced computed tomography (CT), endoluminal ultrasound (EUS), magnetic resonance imaging (MRI), and positron emission tomography (PET-CT), which will be discussed at the preoperative conference.

Patients recommended for major hepatopancreatobiliary surgery (such as a liver resection, pancreaticoduodenectomy, or total/distal pancreatectomy) will be contacted and provided with a participant information sheet. Patients will be divided into three groups according to the type of surgery.

Patients receiving dietary supplementation with mealworms after their pancreatectomy, bile duct resection and hepatectomy will be given the mealworms during their hospitalization period and for another 2months after discharge. The patients in group A will undergo enteral feeding after surgery (for those who undergo a pancreaticoduodenectomy, nutrients will be administered by an enteral feeding tube for early feeding while securing the pancreatojejunostomy). A feeding nasojejunal tube will be placed for patients in the enteral feeding group. Enteral feeding (Newcare 300 RTH, Daesang, Korea) will start within 24h postoperatively at a rate of 20mL/h. The velocity will be progressively increased by 20mL/d until reaching the full nutritional goal (25kcal/kg). Enteral feeding will be delivered by an infusion pump for 18h/day with 6h of rest.

On postoperative day 7, abdominal and pelvic CT scans will be obtained, and if there are no complications, we will then start patients on a clear liquid diet for 1day. In addition, the patients will be permitted to have a full liquid diet for 2days and then a soft diet for 3days following the liquid diet.

The patients of group B will undergo oral feeding 2days after the surgery. (distal pancreatectomy, total pancreatectomy and bile duct resection) We will start patients clear liquid diet for 1day. The patients will be permitted to have a full liquid diet for 2days and soft diet for 3days following the liquid diet.

The patients of group C will undergo oral feeding 2days after surgery (which includes liver resections). We will then start the patients on a clear liquid diet for 1day. In addition, the patients will be permitted to have a full liquid diet for 2days and soft diet for 3days following the liquid diet. The mealworm powder include 3g of carbohydrate, 14.4g of protein and 11g of fat, 163kcal per 30g. (Table 1) As a result of a nutritional analysis of mealworm powder, 10.28g of carbohydrate, 48.26g of protein and 35.81g of fat were found per 100g. In particular, the protein includes essential amino acids as well as many unsaturated fatty acids ranging from 76 to 80% of the total fatty acids. In addition, iron and calcium and other minerals were found (Table 2).

Patients receiving dietary supplementation with grainpowder after pancreatectomy and hepatectomy will be given grainpowder for their hospitalization period and 2months after discharge. The grainpowder include 23g of carbohydrate, 2.9g of protein and 0.5g of fat, 106kcal per 30g. Group A will receive the grainpowder on postoperative day 7. And group B and C will receive grainpowder in the same dose as trial groups mealworms at the start of diet at postoperative 2days (Table 3).

The primary outcome is the body cell mass index as measured by body composition (Inbody S-10 (Biospace, Seoul, Korea)). The secondary outcome measures are as follows: nutritional index (weight, soft lean mass, fat free mass, fat mass, PG-SGA [Scored Patient-Generated Subjective Global Assessment]) and immune function test (that assesses T cells, B cells, cytokines). We will confirm changes in immune cells through FACS (fluorescence-activated cell sorting). Based on the immune assay using blood samples from patients, we will identify changes in several cytokines.

Once the patients surgery is confirmed, the research staff will give the study staff a list of the patients. After determining the suitability of the patient, the study staff will assign the patient to the test or control group in a randomized sequence in the order in which they are enrolled. In addition, they will be assigned in a double-blinded manner.

The researchers will select patients after obtaining consent. Randomization will take place via an allocation randomization system 2days before the surgery, which will be directed by our department. Patients will be randomized to one of the treatment groups in a 1:1 ratio. After consent for study enrollment is obtained, the randomization process will be applied to identify the next allotment. The surgeons will be blind to the allotment throughout the enrollment process.

Patients and all team members will be blinded to the intervention. Adverse event (AE) and serious adverse event (SAE) need to be reported as soon as they are noted. This will not have any impact on the endpoint assessment of the patient.

The amount of food consumed by the patient daily will be assessed as a diary entry. The researcher collects the bags left over from the patients at the outpatient clinic. Individual participant medical information obtained as a result of this study is considered confidential and disclosure to third parties is prohibited. Blood samples transferred to the laboratory of Gangnam Severance Hospital will be identifiable by unique trial numbers only. Results related to nutrient indicators (Inbody, PG-SGA) will be managed by a Gangnam Severance Nutrition Team. The blood sample associated with the immune function test will be transferred to the lab of the study staff in Gangnam Severance Hospital, which will then undergo FACS (Fluorescence-activated cell sorting).

If patients wish to voluntarily withdraw from the study, the patient will be asked if they would be given medical care until any AE symptoms resolve or the patients condition becomes stable.

Patients can quit the trial at any point without the need to give reasons for their decisions. If voluntary withdrawal occurs prior to diet intervention, the patient will not be randomized, and no more trial data will be collected for that patient. Patients can also withdraw from the trial following diet intervention.

All data will be entered into a single Microsoft Excel spreadsheet with participants identified only by their unique subject number. All entries will be double-checked by another member of the research team. Statistical analysis will be performed using IBM SPSS version 21.0 (IBM Corp; released 2012. IBM SPSS Statistics for Windows Version 21.0. Armonk, NY, USA). The mean difference in nutrient intakes, changes in body measurements, changes in body composition, and PG-SGA scores will be calculated using the Wilcoxon signed rank test and the Mann Whitney test.

The research team is responsible for monitoring the study. At 1week after discharge, the participants are asked whether they are willing to continue ingesting the mealworm. Every 2weeks after the patients visit their outpatient clinic, the monitoring researcher will check whether they are taking the mealworm regularly. The research team is also responsible for systematically reviewing the causes of withdrawal from the study. Assessment of these changes will be determined 2months after surgery (Table 4).

The study protocol was approved by the institutional review board at Gangnam Severance Hospital, Yonsei University of Korea (32017-0077). The study complies with the Declaration of Helsinki and the principles of Good Clinical Practice.

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Clinical application of invalid foods using mealworms and evaluation of nutrition status and immune function: a study protocol for a randomized,...

The secret to living past 100 could lie in your immune system, suggests a new study.

In a study recently publishedin Proceedings of the National Academy of Sciences (PNAS), scientists found that supercentenarians those who are 110 years of age or older have an overabundance of a certain type of disease-fighting cell within their immune systems, possibly explaining their longevity.

To come to this conclusion, researchers looked at the circulating immune cells from supercentenarians and controls aged 50 to 89. About 41,208 immune cell samples were taken from seven supercentenarians, while 19,993 cells were collected from the five controls.

The study found that while the supercentenarians and controls had roughly the same amount of T-cells overall, the former group had an excess amount of one particular subset of T-cells called cytotoxic CD4 T-cells. These cells, according to a news releaseon the findings, are aggressive and quickly destroy cancer and infection-causing cells.

In some cases, the cytotoxic CD4 T-cells accounted for 80 percent of the supercentenarians T-cells, while only 10 to 20 percent of the T-cells in the controls were cytotoxic CD4 T-cells, according to the research, which wasconducted by the RIKEN Center for Integrative Medical Science (IMS) and Keio University School of Medicine in Japan.

The super immune system cells are likely not a marker of youth, but rather a special characteristic of the supercentenarians, the researchers wrote. The cytotoxic CD4 T-cells are likely the offspring of a sole ancestor cell.

We believe that this type of cells, which are relatively uncommon in most individuals, even young, are useful for fighting against established tumors, and could be important for immunosurveillance, said Piero Carninci, the deputy director of RIKEN, in a statement. This is exciting as it has given us new insights into how people who live very long lives are able to protect themselves from conditions such as infections and cancer."

Gallery: 100 Ways to Live to 100 (Provided by Best Life)

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Study: The secret of living to 110 - msnNOW

The holiday season is coming up quick, and along with dancing sugar plums and a strong dose of seasonal cheer can come some uninvited guests, including the common cold and flu bug. So, what can you do to give your body the best fighting chance to avoid getting sick this holiday season? Sleigh Family Chiropractic offers the following tips to help boost your immunity system with the goal to remain among the healthy:

Decrease Sugar Intake and Exercise: Avoiding too much sugar (especially at all those holiday parties) can be a bit of trick. Over-consumption can substantially decrease the immune system's ability to attack viruses and bacteria for up to eight hours after you enjoy that delicious piece of pie. Meanwhile, getting just 30 minutes of exercise (maybe before or after the party) each day can help the immune system to remain strong against infection.

Reduce Your Stress: The holidays can create a variety of stress for some, which is a natural immune depressor. Different ways to reduce stress include utilizing deep breathing exercises, meditation and yoga, or simply scheduling some time for yourself. Whether it's a day at the salon for a mani/pedi, a massage, spending time with your favorite friends, or taking a peaceful (and potentially brisk) walk in the park, take the steps that will help you keep it stress-free over the holidays.

Get More Sleep: More sleep simply makes sense it allows your body to recharge and take on all the challenges of the day. Ashwaghanda is an herb that has been shown to reduce anxiety and encourage calm and relaxation. It is made up of phytochemicals called withanolides that are believed to reduce the body's stress response and help to achieve restful sleep. Other tips include having a consistent wake up and bedtime routine and avoid 'blue light' activities such as using a computer or a cell phone up to two hours before going to bed. Keep your office out of the bedroom; allow it to be a sanctuary away from technology that invites rest and relaxation.

Eat Foods High in Vitamins C & D or Take Supplements:

Try Elderberry Syrup: The berries and flowers of elder trees and plants (known as Sambucus nigra) contain antioxidants and vitamins that have shown promise in boosting the immune system over centuries. The use of these trees and plants, and the syrup that comes from them, dates to 400 B.C. and Hippocrates, who called the elder tree his 'medicine chest'. Elderberry syrup has also been used to reduce stress and inflammation, as well as protect the heart.

Wash Your Hands Frequently: Washing your hands often, with soap, is one of the easiest ways to avoid spreading germs to others and yourself. Germs can be spread through contact with your eyes, nose and mouth, and can be transmitted through a variety of surfaces. Remember to wash your hands often to reduce the spread of sickness, especially over the holidays so you can enjoy all the festivities.

Katie and Quintin Sleigh, along with the entire Sleigh Family Chiropractic team wish you and yours a very happy - and healthy - holiday season!

About Sleigh Family Chiropractic

Drs Katie and Quintin Sleigh own and operate Sleigh Family Chiropractic, a family wellness clinic located at 3285 N. Arlington Heights Road in Arlington Heights. For more information, call 847-788-0880 or visit SleighFamilyChiropractic.com.

Resources/Reference Information:

Original post:
Immunity Boost Tips to Help You Stay Healthy Over the Holidays - Patch.com

Immunotherapy is a form of cancer treatment that is now being used to treat many different types of cancer. However, stimulating the immune system through activated t-cells may result in T-cells acting upon other body systems or organs, unable to distinguish the cancer, causing inflammation and other adverse events (AEs).

Beth Eaby-Sandy, nurse practitioner at the Abramson Cancer Center, spoke at theCUREpatient-focused sessions held in tandem with theAnnual New York Lung Cancers Symposiumabout immunotherapy AE management. Your body is in a constant state of self-tolerance, she said. These drugs that we use do 1 of 2 things. We are either trying to stimulate the immune system to kill cancer [or] were trying to stop cancer from alluding the immune system.

Any body system or organ can become inflamed or damaged by the overactivity of T-cells. Some types of immunotherapy may result in severe inflammation-related reactions. If patients are experiencing any AEs from immunotherapy, they should be seen and treated immediately.

Hypothyroidism is one of the most common AEs caused byimmunotherapy. Once immunotherapy disables the thyroid gland, it is permanent, and the patient will not regain thyroid function and must then be on levothyroxine for life. Patients may also experience hyperthyroidism, though less common, causing a patient to over-secrete thyroxine and can lead to hypothyroidism if prolonged.

Fatigue is commonly reported in patients who receive immunotherapy, though it is unclear as to what causes it. Another common AE of immunotherapy can be arthritis, induced by T-cells attacking the joints. Low-dose steroids or other drugs traditionally used to manage arthritis are recommended for patients. Nausea and diarrhea (without colitis) have been reported, though not necessarily known why.

More AEs include:

Lowering of blood counts is not commonly seen in immunotherapy as it is in chemotherapy. Hair loss should also not occur, though hair thinning may.

Dont be afraid of immunotherapy! The majority of these patients do very, very well for often long periods of time, so its not something to be afraid of. We can usually manage these side effects very easily, Eaby-Sandy said.

Reference:

Eaby-Sandy. Immunotherapy Adverse Effect Management. Presented at:CUREpatient-focused sessions held in tandem with theAnnual New York Lung Cancers Symposium; November 9, 2019; New York, New York.

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Adverse Events To Be Aware of With Immunotherapy Treatment in Lung Cancer - Cancer Network

A new project has shown how a one-off injection can halt peanut allergies for up to six weeks.

Scientists from Stanford University School of Medicine carried out a small pilot study involving an injectable antibody treatment that allows people with severe peanut allergies to eat a peanut with no trouble at least two weeks later.

Allergiesare simply a misguided overreaction by the bodys immune system. We typically experience an immune response to a foreign substance or pathogen that could cause harm to the body. With allergies, however, the response is fired up to substances that arent actually harmful to your body, such as the protein in peanuts, a rogue piece of pollen, or pet hair.

The only currently available treatment, oral immunotherapy, involves the patient eating minuscule but escalating doses of the allergen over the course of months, eventually desensitizing their immune system to the substancein question.

The new treatment takes a much more direct approach. Reported in JCI Insight, the treatment called etokimab works to interfere with an immune-signaling molecule known as interleukin-33 which triggers the chain of events that amount to a full-blown immune system response.

By inhibiting IL-33, we potentially inhibit features of all allergies, which is promising, senior author Kari Nadeau, professor of medicine and of pediatrics at Stanford, said in astatement.

Whats best, and quite surprising, is how long the treatment lasts. The double-blind study involved 20 participants with severe peanut allergies 15 received a single etokimab injection and five were given a placebo. Up to 15 days later, 73 percent of the etokimab group was able to eat a nuts worth of peanut protein without any allergic reaction. By day 45, 57 percent of them were able to.

The small study only involved 20 participants, but its success holds real hope for the 32 million Americans who suffer from potentially deadly food allergies. Next up, the researchers are looking to carry out another study with more participants and take a deeper look at the mechanisms involved.

Perhaps most promising of all, the treatment could theoretically be used to protect against a whole host of allergens, not just peanuts.

Whats great about this treatment as an option for food allergies is that people did not have to eat the food to get desensitized, Nadeau added. Although this is still in the experimental stages, were delivering on the hope of testing a drug that wont be for one food allergy but for many, and for other allergic diseases, too.

Cases of food allergies, along with eczema and hay fever, have risen rapidly in the developed world over the past few decades. There are thought to be a number of explanations for this, ranging from adecreased exposure topathogens to a change in diet. Regardless, despite this increase,allergies remain surrounded by myth and misinformation. Here are some common myths about allergiesthat you should be aware of.

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A Single Injection Stops Peanut Allergies For Up To Six Weeks - IFLScience

MENLO PARK, Calif.--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced that the company will participate in the AACR Tumor Immunology and Immunotherapy conference at the Boston Marriott Copley Place in Boston, MA, November 17-20, including poster presentations on November 18th and 19th.

The company will showcase ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Following is a list of abstracts that will be presented at the meeting.

Scientific Poster Presentations

Poster Number

Title & Presenter

Day & Time

Location

A19

HLA allele-specific loss of heterozygosity detectionusing augmented exome capture approach

Presenter: Rachel Marty Pyke, Ph.D.

November 18:12:30 PM 3:00 PM

Back Bay

B18

Exome scale liquid biopsy monitoring of putativeneoantigens and genomic biomarkers in patientson anti-PD-1 therapy in squamous cell carcinoma ofthe head and neck

Presenter: Charles Abbott, Ph.D.

November 19:4:30 PM 7:00 PM

Back Bay

Personalis will also be exhibiting during the conference (Exhibit # 10). Representatives will be available to answer questions about the companys cancer immunogenomics services.

About Personalis, Inc.

Personalis, Inc. is a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patients cancer and immune response. The companys NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. Personalis also provides genomic information to the VA Million Veterans Program as part of their goal to sequence over a million veteran genomes. The Personalis Clinical Laboratory is GxP aligned as well as CLIA88-certified and CAP-accredited. For more information, please visit http://www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

Link:
Personalis, Inc. to Present New Data at the AACR Tumor Immunology and Immunotherapy Conference - Business Wire

According to results of a study presented at the Society of Immunotherapy for Cancer (SITC) Annual Meeting 2019 in National Harbor, Maryland, a next-generation sequencing (NGS)-based approach was capable of simultaneously characterizing all 7 T- and B-cell receptor chains, and also provided potential predictors of treatment benefit in patients with renal cell carcinoma (RCC).

An extensive repertoire of T-celland B-cell populations that expresses a wide range of antigen-specificreceptors are at the heart of the adaptive immune system. More specifically, T-and B-cell receptor diversity is created through random recombination ofvariable (V), diversity (D), and joining (J) gene segments, or V and J genesegments alone. Hence, at any given point in time, the T-cell and B-cellrepertoire in a single individual is represented by a huge number of differentT- and B-cell clones or clonotypes.

Recently, high-throughput NGS hasbeen used to profile the diversity of the T-cell and B-cell repertoire inindividuals. One approach to this process involves RNA-based multiplexpolymerase chain reaction (PCR) amplification of V-D-J or V-J gene segments,followed by high-throughput sequencing of the PCR amplicons, and subsequentbioinformatic interpretation of the reads obtained through NGS.

In thisstudy, a novel quantitative PCR-based NGS technique was reported to allow forthe simultaneous characterization of RNA associated with the loci of all 7 T-and B-cell receptors (ie, the alpha, beta, gamma, and delta chains of theT-cell receptor; and immunoglobulin (Ig)-K and Ig-L of the B-cell receptor)collected from both peripheral blood mononuclear cells (PBMCs) andformalin-fixed paraffin-embedded (FFPE) specimens from patients undergoingtreatment for RCC.

Furthermore,this process was carried out as single reaction that circumvented the problemof PCR dimer artifacts.

Results of this study suggestedthat pretreatment diversity in T-cell receptor alpha and beta chains, as wellas the B-cell to T-cell expression ratio, may be useful predictors of treatmentresponse in patients with RCC.

Reference

Depinet M, Pan W, Wu S, et al. All-in-One, quantitative immune repertoire profiling of PBMC and FFPE for renal cancer treatment evaluation. Presented at the Society for Immunology of Cancer (SITC) Annual Meeting 2019. November 6-10, 2019. National Harbor, MD. Abstract P87.

Read the rest here:
High-Throughput Multichain Immune Repertoire Sequencing for Prediction of Treatment Response in Renal Cell Carcinoma - Cancer Therapy Advisor

Tis the season for turkey trots, Black Friday sales and fighting over the last piece of pumpkin pie. Oh, and the flu.

According to the U.S. Centers for Disease Control and Prevention, 3% to 11% of people in the U.S. have to deal with the flu each year, with an average of 8% getting sick. And while the flu vaccine is a must, it still only reduces your flu risk by 40% to 60%, meaning its not a complete safeguard depending on your health, age and the type of flu virus you contract. (If you do contract the flu after youve gotten a flu shot, the vaccine will lessen the severity of symptoms and help prevent against flu-related complications like pneumonia. So its still important to get it.)

Here, flu experts share what happens once youre exposed to the flu including why it triggers some of those unpleasant symptoms like fevers, aches and chills. Read on to learn, plus get some guidance on how to stay as protected as possible this flu season.

First, the flu has to find a way to get into your body

Simply being in the house with someone who has the flu wont get you sick, but it can definitely increase your risk factor if youre not practicing proper hand-washing hygiene.

The virus has to find a way to get into either your nose or mouth, said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Its usually transmitted from person to person through coughing, sneezing, or mucus or saliva that might be on someones hands. It can also be transmitted from common surfaces that people may touch. They may have wiped their nose and then touched their hands before putting it on a surface or may have sneezed on the surface.

Your eyes and ears may be access sites as well, but Adalja said these are far less common entry points, so make sure you wash your hands often and well during flu season to prevent the virus from infecting you to begin with.

You wont have symptoms right away once the virus enters your system

Once the virus enters your nose or mouth through direct contact (like being sneezed on, yuck) or indirect (such as using a towel shortly after an infected person has previously used it) the virus will make its way to your immune system, but this wont happen immediately.

Once the flu gets into your body, it will set up shop and cause the same infection in you, said Aaron Glatt, chairman of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Hewlett, New York. The incubation period is about one to four days. On average two days, but it is still a highly contagious disease during this time.

This means that you could be asymptomatic for a day or two but very much able to spread the flu to others without even knowing it.

torwai via Getty Images

Once the flu settles in, its heading for your cells

Specifically, the virus goes to your respiratory epithelial cells, which line your respiratory tract.

The virus binds to sialic acids that are on these cells, and these sialic acids function as receptors to help the cells signal and communicate to each other, Adalja explained.

The virus is able to bind to these cells thanks to a protein called hemagglutinin (which is what the H stands for in flu strains like H1N1). With the help of this protein, the virus attaches itself to the cell and then gets inside the cell, which will send an alarm to your immune system.

Some flu symptoms are from an immune system response

After your immune system figures out theres a virus inside the body, it will go into overdrive to get it out as quickly as possible.

As part of that, the immune response will start to ramp up some of the symptoms that you feel. Fevers, muscle aches and pains are the result of certain chemicals being secreted by the immune system in order to fight that virus off, Adalja said, adding that a quarter of people with the flu have no symptoms. This doesnt mean your immune system isnt working, its just how you clinically present the virus.

Basically, your body becomes a battlefield when you have the flu and the reason you feel so terrible is from the war between the pathogen and your immune system, Adalja said.

Prostock-Studio via Getty Images

The average shelf life of the virus is about a week

Most healthy people have self-limited disease, Glatt said. They get sick for a couple days, or some people dont get very sick at all. Other people get a mild illness or more moderate illness for a couple of days or a week or two at most.

The standard run-of-the-mill flu in a healthy person typically doesnt require treatment but certain groups are at a higher risk of developing complications from the flu including pregnant women, those with certain underlying diseases, children less than 12 months old, or adults over the age of 65.

Glatt said for these groups especially, its important to make an appointment with a physician as soon as flu symptoms come on. Theyll be able to prescribe an appropriate antiviral medication to help relieve symptoms and clear the virus out of your body as fast as possible. (This is also good general advice, as doctors can prescribe medications like Tamiflu to help reduce the severity and length of the illness.)

Other than that, get lots of rest, drink fluids and monitor your symptoms. While you may be miserable for a few days, your body will fight the flu the best it can.

Read this article:
This Is Your Body On The Flu - HuffPost

NFM Secret Shopper: Im confused about whats best to boost my immunity. Is it zinc, vitamin C, vitamin D, elderberry or something else?

Retailer: Any of those can help with immunity, but it depends on when you take them. Vitamin C is good for when you already have a cold, but if you eat your fruits and veggies, you probably dont need to take a vitamin C supplement all the time. Same with zinc and elderberry. But vitamin D is a supplement you might need every day, depending on your levels.

NFM: That makes sense. Any other supplements youd recommend, especially for cold and flu season?

Retailer: Garlic is popular and seems to work pretty well for immunity.

Our expert educator: Yufang Lin, M.D., of the Cleveland Clinics Center for Integrative and Lifestyle Medicine

Immunity is very complex. As an integrative practitioner, I look at the whole picture, so the first things I suggest are getting enough sleep, hydrating well and eating healthy. As for specific foods that boost immunity, garlic and ginger are both antimicrobial, antifungal and antiviral. You can use them in your day-to-day cooking, but if you are getting sick, definitely step up your intake, whether through food or supplements. Ginger, which is also anti-inflammatory, can also be made into tea.

There is data showing that both vitamin C and zinc support the immune system when you are sick. They are particularly useful in the first few days of illness, as they can reduce the duration and severity. But use these supplements only as needed, not on a long-term basis.

Elderberry is a diuretic, so if you are running a fever, it can help you sweat it out. Another supplement, echinacea, revs up the immune system, so it is great for fighting off a cold or even for the early stages of the flu. The problem with echinacea is it can stimulate the immune system too much, which is bad if you have an autoimmune disease. But for most people, it can be very helpful, but take it only for three to five days.

Vitamin D is a hormone so it generally has many benefitsfor mood, bone health and immune support. But it is more for day-to-day care, not to start taking once you get sick.

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Secret Shopper: What supplements are best to boost immunity? - New Hope Network

The presence of the fungusAspergillushas forced theclosingof 11 operating rooms at Seattle Childrens Hospital, marking the second such closure in a year. All 14 of the hospitals operating rooms will be closed later in the week, said hospital spokeswoman Kathryn Mueller.

"On November 10, routine air test results revealed the presence ofAspergillusin the air in 3 of our operating rooms and 2 procedural areas," Mueller said. "The rooms in whichAspergilluswas detected have been closed. We are also investigating 2 new potentialAspergillussurgical site infections."

The hospital has had to postpone some surgeries and move others to different hospitals.Aspergillusis a fungus whose spores are present in the air and can cause illnesses in people with weakened immune systems, damaged lungs, and asthma. Infections caused byAspergillusincludeinvasive aspergillosis,ABPACPA, and aspergilloma.

Seattle Childrens Hospital says that the fungus has infected at least 1 patient, and possibly 2. This is the second time the fungus has been discovered in the hospitals operating rooms. The previousAspergillusoutbreak inMayled to at least 5 infections and 1 death.

Hospital officials blame the presence ofAspergillusin the operating rooms on deficiencies in ventilation and purification systems.

AnarticleinHPAC Engineeringnotes that hospitals consume much more energy than buildings and facilities in other industries of similar size. More energy is therefore needed to ventilate and purify the air.

Healthcare facilities that may not be properly ventilated, designed, or controlled can lead to the spread of airborne pathogens throughout the facility, according to the article. Hospital patients who have compromised immune systems and are more susceptible to infection will likely be infected and can spread pathogens to the rest of the hospital.

The article, which ran last year, also focused on the importance of a good filtering system in facilities and touts the benefits of bipolar ionization systems. They create negative and positive ions which then react with oxygen and water vapor within the air stream, creating free radicals. These free radicals in turn create chemical changes, which can damage viruses, bacteria and other microorganisms that often cause infections within a hospital. Even with this kind of system, filter media is still necessary to remove larger particles from the air stream. A filter media is anything in a filter that changes the quality of whats being filtered.

The Infectious Diseases Society of America (IDSA) recommends that the response toAspergillusinfection should involve submitting tissue and fluid specimens for histopathologic, cytologic, and culture examination to diagnose invasive aspergillosis. However, molecular techniques, such as DNA sequencing, should be used to identifyAspergillusspecies in cases that involve either isolates with atypical growth or concern for resistance, the IDSA recommends.

Astudythis year inAntimicrobial Resistance & Infection Controlnoted that the construction work at hospitalswhich seems to be happeningmore and morecan help breed invasive aspergillosis (IA)infection.

Investigators with the University of Ulsan College of Medicine in South Korea, wrote: Airborne fungal spore levels tended to be higher during the period with heavier construction works involving demolition and excavation, during which the incidence of IA was significantly higher as well.

They argued that airborne fungal spore levelsshould be monitored when constructions taking place in hospitals with patients who have compromised immune systems.

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Aspergillus Endangers Children at Hospital for Second Time This Year - Infection Control Today

The iMUSE yoghurt & lemon flavoured drink contains lactococcus lactis strain plasma which the firm claims to have immune functionality to fight infectious disease in the country.

The drink contains 100 billion lactococcus lactis plasma, which is a lactic acid bacteria and an ingredient used exclusively by the Kirin Group.

According to Interfood Shareholding Company (Kirin Holdings subsidiary), general manager of marketing, Takeshi Fukushima: The Health and well-being trend is emerging in Vietnam. More people are taking up supplements.

The firm said while Vietnamese were highly health-conscious and spending more money on nutritional healthcare products, it said the spread of infectious diseases like dengue fever and hepatitis in the country was becoming a problem.

Hence, the yoghurt & lemon flavoured drink could propose new health value of drinking soft drinks to manage ones health in an effort to help the country solve the social problem, Kirin said.

Fukushima said the drink was able to enhance the anti-viral immune system and maintain overall health.

Its other benefits include reducing the risks of cold and flu symptoms, enhance health of skin from the inside, and reduce symptoms of fatigue in physical activity.

The Kirin Group is currently conducting research especially in the area of infectious diseases, to help those vulnerable, and contribute to achieving the United Nations Sustainable Development Goals (SDGs).

Fukushima told NutraIngredients-Asia, the first month of sales in Vietnam achieved 250% versus target.

It retails for 13,000VND (US$0.50) per 280ml at supermarkets, convenience stores, school cafeterias, and school stores in Vietnam.

Kirin Group had only promoted the iMUSE brand containing lactococcus lactis strain plasma mainly in Japan.

The drink is the first product sold overseas under the iMUSE brand.

This move is part of Kirins business strategy to expand the iMUSE brand in South East Asia.

Vietnam was selected for its population of 94 million, and 7.1% annual real-term growth in gross domestic product (GDP).

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Kirin's functional food brand expands to Vietnam with immunity-boosting probiotic drink - BeverageDaily.com

In a new study, scientists observed several simultaneous reactions in mice given a common chemotherapy drug: Their gut bacteria and tissue changed, their blood and brains showed signs of inflammation, and their behaviors suggested they were fatigued and cognitively impaired.

The research is the first to show these combined events in the context of chemotherapy, and opens the door to the possibility that regulating gut bacteria could not only calm chemo side effects like nausea and diarrhea, but also potentially lessen the memory and concentration problems many cancer survivors report.

More research is needed to further understand how the chemo-modified gut influences the brain in a way that can have an impact on behavior. The same lab at The Ohio State University is continuing mouse studies to test the relationship and running a parallel clinical trial in breast cancer patients.

This is the first time anyone has even looked to see if theres a link between the gut symptoms and the brain symptoms associated with chemotherapy, said lead author Leah Pyter, assistant professor ofpsychiatry and behavioral healthand an investigator in theInstitute for Behavioral Medicine Researchat Ohio State. There have been studies in humans that indicate that chemo alters microbes in the gut, and our study in mice had similar results.

We were able to see that there are brain changes at the same time as the gut changes. We also looked at inflammation, and yes, there are all these changes happening at the same time. So there are correlations, and now were looking into causality.

The study is published today (Nov. 11) in the journal Scientific Reports.

For this study, female mice received six injections of the chemotherapy drug paclitaxel and a control group of mice received placebo injections. Compared to the controls, the treated mice lost weight and showed signs of fatigue, and their performance on tests suggested they had memory loss.

The treated animals guts, blood and brains were also affected in ways not seen in the control mice. The mix of bacteria in the gut microbiome changed, and the tissue lining the colon became abnormally extended. Specific proteins were present in circulating blood and the brain along with activated immune cells in the brain all indicating the immune system was busy producing a total-body inflammatory response.

The sequence of events suggested all these physiological changes were related: The gut was showing signs of permeability, meaning bits of bacteria could slip out of tight junctions in the intestine, an event that triggers an immune system attack. When the brain detects through the blood and neural signals that the bodys immune system is activated, the brain responds in kind with its own inflammation. And brain inflammation is the culprit behind the mental fog symptoms known as chemo brain.

Pyters team tested all the data for associations and found the strongest correlations between changes in the gut microbes and in the colon lining and the activation of immune cells called microglia in the brain.

Every time chemo reduced bacteria in the gut, that reduction was correlated with these cells in the brain, said Pyter, also a member of theCancer Control Research Program at Ohio States Comprehensive Cancer Center.

This suggests chemotherapy is affecting the microbes in the gut and affecting the lining of the gut, and both of those changes cause inflammation in the periphery, which creates signals that promote inflammation in the brain, she said. Thats how we get the brain involvement through the immune system. And inflammation in the brain leads to sickness behaviors like fatigue and weight loss, as well as cognitive impairment.

Confirmation of these connections could lead to interventions for cancer patients either dietary strategies such as probiotics or prebiotics or possibly fecal transplantation to promote bacteria and conditions in the gut that protect the brain from inflammation, which should reduce chemo brain symptoms.

This is just the first step of trying to broach the concept to see if these harsh gut effects of chemo have anything to do with chemo brain. It looks like it has potential, Pyter said.

This work was supported by The Ohio State University Wexner Medical Center and grants from the National Institutes of Health.

Kelley Jordan and Browning Haynes of Ohio State and Brett Loman and Michael Bailey of Nationwide Childrens Hospital were study co-authors.

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The gut may be the ticket to reducing chemo's side effects - The Ohio State University News

SAN DIEGO and PENNINGTON, N.J., Nov. 12, 2019 /PRNewswire/ --OncoSec Medical Incorporated ("OncoSec") (Nasdaq:ONCS), a company developing late-stage intratumoral cancer immunotherapies, today announced outcomes from a safety and biomarker analysis on its lead product candidate, TAVO, at theSociety for Immunotherapy of Cancer(SITC) 34th Annual Meeting. Outcomes demonstrated treatment-related changes in key immune biomarkers coinciding with clinical outcomes across both KEYNOTE-695 and KEYNOTE-890 trials of TAVO in combination with KEYTRUDA (pembrolizumab).

In the poster, which was presented on November 9, 2019, investigators noted that following TAVO administration, increased tumor infiltrating CD8+ T-cells were consistent with tumor shrinkage in anti-PD-1 antibody refractory melanoma and chemotherapy refractory metastatic triple negative breast cancer (mTNBC). The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported. There were no Grade 4 or 5 treatment-related adverse events reported and only 7.9% of patients experienced Grade 3 treatment-related adverse events across all TAVO studies, underscoring a predictable and consistently well-tolerated safety profile.

OncoSec is currently evaluating TAVO in combination with KEYTRUDA in a pivotal trial for Stage III/VI anti-PD1 checkpoint resistant metastatic melanoma and a phase 2 trial for late stage chemo-refractory metastatic TNBC, both KEYNOTE-designated studies. The immune data presented at SITC represented those patients for whom pre- and post-treatment blood and tumor samples were obtained in these ongoing KEYNOTE studies.

"The data presented at SITC were consistent with earlier published data showing that the well-established indicators of immune response are present in the blood and tumor tissue post-treatment and that the presence of these immune signatures continues to be associated with clinical response," said Daniel J. O'Connor, CEO of OncoSec. "Further, with more than 200 TAVO-treated patients, we clearly see that these powerful clinical responses are delivered with an excellent safety profile as both a monotherapy and importantly, in combination with anti-PD-1 therapy."

About OncoSec Medical IncorporatedOncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec has built a deep and diverse clinical pipeline utilizing its primary technology, TAVO(tavokinogene telseplasmid) as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non- responders. In addition to TAVO, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visitwww.oncosec.com.

TAVOis a registered trademark of OncoSec Medical Incorporated.

KEYTRUDAis a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Forward Looking StatementsSome of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the status, progress and results of our clinical programs; our ability to obtain regulatory approvals for, and the level of market opportunity for our product candidates; our business plans, strategies and objectives, including plans to pursue collaboration, licensing or other similar arrangements or transactions; expectations regarding our liquidity and performance, including expense levels, sources of capital and ability to maintain operations as a going concern; the competitive landscape of our industry; and general market, economic and political conditions; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Company Contact:Gem HopkinsHead of Corporate Communications858-210-7334ghopkins@Oncosec.com

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SOURCE OncoSec Medical Incorporated

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OncoSec Presents Immunological Data Associated with Positive Tumor Response from TAVO(TM) KEYNOTE Studies Evaluating Patients with Advanced Solid...

A nurse prepares a vaccine against Ebola in Goma on August 7, 2019. (Photo by AUGUSTIN WAMENYA/AFP ... [+] via Getty Images)

Its official. We now have a real Ebola vaccine. Not a kind-of-almost-sort-of-there vaccine. Not an experimental-use vaccine. Not a vaccine just for macaques. No, this is a vaccine that the European Commission has just approved for use in humans, the first of its kind.

According to todays announcement, the European Commission has granted Merck Sharp and Dohme B.V. marketing authorization in Europe for their Ebola vaccine, named Ervebo. The approval came not too long after the European Medicines Agency (EMA) had recommended approval in mid-October.

This is big. Actually, its big times big plus big. Having a vaccine to protect against the Ebola virus is a game changer. The Ebola virus, in technical terms, really sucks. It is a nasty virus that can cause a severe and deadly hemorrhagic fever. Fever means fever as in body temperature rising. And hemorrhagic means bleeding as in blood leaking out of blood vessels inside your body, in your skin, and potentially in your eyes, nose, ears, mouth, and rectum.

05 September 2019, Congo, Goma: Signposts on the premises of the UN peace mission "Monusco" point ... [+] out symptoms, danger of infection and course of disease of Ebola. (Photo by Kay Nietfeld/picture alliance via Getty Images)

How can the virus wreak such havoc? The virus is a sneaker sucker. It first targets cells that serve as your immune systems first line of defense. This is a bit like the Oceans 11 crew taking out the surveillance system first when trying to rob Terry Benedicts casino. As a result, your immune system cannot even recognize that something is amiss. Eventually, macrophages, which are your bodys cookie monster-like protectors, gobble up the viruses. This then triggers your macrophages to do the wrong thing. Your macrophages release proteins that initiate a cascade of events that cause the formation of small blood clots, inflammation, and leaks in your blood vessels throughout your body. This leads to the unhappy combination of you losing blood and blood flow to your organs being blocked, which starves your organs of oxygen. This process is what ends up killing up to 90% of those infected by the virus, according to the World Health Organization (WHO) Africa Region Office.

If this sounds horrible, it is. Ebola infections can be costly too. As our PHICOR teams study published in the Journal of Pathogens and Global Health showed, the cost of each case can range from several hundred dollars (if you fully recover) to close to $20K if you dont survive.

Here is the Ebola virus under a microscope. (Photo: Getty Images)

Thats why you never want to get infected by the Ebola virus. You can catch the virus from contacting the body fluids of an infected person, fruit bat, or non-human primate such as an ape or monkey. As the Centers for Disease Control and Prevention (CDC) explains, until now, the only thing that you could do to prevent an Ebola infection was to avoid the virus. That may be relatively easy in the U.S. where the Ebola virus so far has been exceedingly rare. However, that aint so easy in the middle of an outbreak such as the one that rocked West Africa from 2014 to 2016.

The Ebola vaccine works by exposing you to a form of the virus that cant cause an infection. This then prompts your immune system to in effect say, hmm, what is this? Oh, this doesnt look good. We should get prepared for when this virus returns. Think of Terry Benedict being shown the Oceans 11 crew and their plans before they even attempt the heist and how that would help the casino shore up defenses.

Health officials have been using the vaccine on an experimental basis to try to control Ebola outbreaks that have been going on in the Democratic Republic of the Congo (DRC). As described in this PBS Newshour segment, the war-torn DRC hasnt been the easiest place to test the vaccine:

Nevertheless, researchers managed to test the efficacy of the vaccine in the country. As the WHO reported in April, this vaccine had an estimated protective efficacy of 97.5% in field studies there. That would mean if a hundred people vaccinated were exposed to the virus, less than three would end up getting infected. Thats a remarkably high efficacy. After all, nothing in life is 100%. However, keep in mind that the efficacy of a vaccine also depends on how many people around you are vaccinated as weve seen with the measles vaccine as I have explained for Forbes previously.

Ebola and the Ebola vaccine didnt always get the attention that its getting today. In fact, as chronicled in the scientific journal CMAJ, the history of the Ebola vaccine reads sort of like an ugly duckling, Shes All That movie story line. It wasnt until the year 2001 that the Public Health Agency of Canadas National Microbiology Laboratory began in earnest attempts to develop an Ebola vaccine. Back then Ebola researchers struggled to secure funding because Ebola wasnt exactly a household name and working on the virus wasnt considered cool or sexy by the public and thus policy makers.

Despite these hurdles, the researchers at the Canadian laboratory persisted and by 2005 managed to develop a vaccine had perfect efficacy in protecting macaques, based on a study published in Nature Medicine. This was good news, for macaques. While these results were promising, much more work was necessary to proving that a vaccine could work in humans and be appropriately safe. Although the Canadian government had patented the vaccine, at the time, the future of the vaccine remained uncertain. It wasnt as if pharmaceutical companies were lining up to further develop the vaccine.

Everything changed in 2014 when the West Africa Ebola outbreak made international news. Suddenly, people in other continents began wondering and worrying about this deadly disease that could cause bleeding eyeballs. There were concerns about Ebola spreading to the U.S. and Europe. People who previously had never heard of Ebola were clamoring, do something, do something! Seemingly overnight, the previous wallflower Ebola vaccine had become the prom king or queen or at least someone invited to the prom. Merck then entered the picture to subsequently take the Canadian vaccine to the finish line and approval.

Having a major regulatory body like the European Commission approve the vaccine is a major step towards other regulatory bodies around the world following suit. The U.S. Food and Drug Administration (FDA) is currently reviewing Mercks application for approval. So stay tuned for news from the FDA by the first quarter of 2020 about possible approval in the United States.

The Ebola vaccine approval is a major public health success. As history has shown, the advent of a vaccine can dramatically dampen the spread of an infectious disease, in many cases taking it from a clear and present danger to something that people dont have to worry about on a regular basis. Just look at what happened to measles after the measles vaccine was introduced. Actually, just look at what happened to measles at least until 2000, before some people thought that it would be good idea to tell people to stop getting vaccinated.

Ervebo wont be a blockbuster money maker for Merck. Vaccines typically are far from the most profitable products for pharmaceutical companies, and the Ebola virus is far from common in higher income countries. Thus, the global health community will need to find ways to support and fund use of this vaccine. Alas, the Ebola vaccine will continue to face this and other obstacles after approval such as finding ways to get people vaccinated. Nevertheless, this approval news is still a big times big to the biggeth power step forward.

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The Ebola Vaccine Is Now Officially Here With Approval In Europe - Forbes

NATIONAL HARBOR, Md., Nov. 9, 2019 /PRNewswire/ --Rakuten Medical, Inc. (RMI) a clinical-stage, global biotechnology company developing precision-targeted cancer therapies based on Rakuten Medical's Illuminox, its proprietary, anti-cancer treatment platform, introduced new preclinical data suggesting CD25 photoimmunotherapy (PIT) treatment, combined with an anti-PD1 therapy, may stimulate the immune system, and lead to a synergistic, anti-cancer activity in targeted tumors.

"These exciting data suggests that anti-CD25 photoimmunotherapy may alter the immune tumor environment and unlock the potential of combination immunotherapies for patients living with certain types of cancers for which there are few treatment options," said Miguel Garcia-Guzman, Ph.D., Vice Chairman and Chief Scientific Officer at Rakuten Medical. "We are committed to harnessing the full potential of the immune system through modulation of the cancer tumor environment, and these results support our clinical development program based on our anti-cancer treatment platform, Rakuten Medical's Illuminox."

The preclinical data were showcased during a poster presentation during the Society for Immunotherapy of Cancer (SITC) 34th annual meeting:

"Intratumoral depletion of regulatory T-cells using CD25 targeted photoimmunotherapy elicits anti-cancer immune activity and synergizes with PD1 checkpoint blockade in immunocompetent mouse models." (Abstract P774), presented by Jerry J. Fong, Cancer Biology and Pharmacology, Rakuten Medical.

The poster discusses intratumoral depletion of regulatory T-cells (Tregs), a significant source of immune suppression, with an anti-CD25-IR700 conjugate therapy using PIT. Anti-cancer activity and subsequent immune responses following anti-CD25-IR700 PIT treatment, administered alone or in combination with anti-PD1 treatment, were evaluated in immunocompetent mouse models. Key highlights from the studies include:

About Rakuten Medical Rakuten Medical, Inc. (RMI) is a privately funded, clinical-stage biotechnology company with offices in the U.S., Japan, Taiwan, Germany and the Netherlands. Rakuten Medical aims to become a leader in precision-targeted medicines through Rakuten Medical'sIlluminox, its proprietary, anti-cancer treatment platform. The Company's lead product, ASP-1929, the first investigational product based on RMI's Illuminox, has achieved Fast Track designation from both the FDA and the Japanese Ministry of Health, Labour, and Welfare. ASP-1929 is currently the subject of a global, Phase 3 clinical trial for recurrent head and neck squamous cell carcinoma. Additional Phase 2 studies for ASP-1929 are also underway to evaluate the safety in patients with other cancer types. For more information, visit http://www.rakuten-med.com.

About Rakuten Medical's IlluminoxRakuten Medical'sIlluminox is a proprietary, anti-cancer treatment platform that is comprised of drug, device and other related technologies. Transient excitation of a drug, including antibodies conjugated to light-excitable dyes, with non-thermal light is believed to result in anti-cancer activity and in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. It may also lead to the systemic induction of innate and adaptive immunity. RMI's Illuminox is based upon the photoimmunotherapy treatment platform developed at the National Institutes of Health (NIH) and licensed exclusively to Rakuten Medical for commercialization. None of the therapies based on RMI's Illuminox have been approved by any regulatory authority. The RMI Illuminox platform is not a drug nor device on its own and is not the brand name of a drug nor device.

Forward Looking StatementThis press release contains forward-looking statements made pursuant to the safe harbor provisions ofthe (United States) Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties, and assumptions that could cause Rakuten Medical'sactual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These forward-looking statements include information concerning its proprietary anti-cancer platform known as Rakuten Medical's Illuminox and the commercialization of services related to Rakuten Medical products such as the investigational product ASP-1929 and other initiatives toward regulatory approval for products to be sold and marketed. These products may not successfully be granted regulatory approval to be sold and marketed, or may not be commercially successful. Forward-looking statements suggest potential profitability, efficacy and safety, and the status of the application for approval. Rakuten Medicalhas in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest," "plans,""strategizes," "likely", "will", and similar expressions. Such forward-looking statements are based upon Rakuten Medical's current beliefs. Moreover, this press release states an opinion related to clinical research data, hence the use of expressions such as "important," "notable" and "abnormal." Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of ASP-1929 which may be impacted by, among other things, problems with the manufacturing process for ASP-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties, both reasonable and unreasonable. Rakuten Medicalundertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect new information obtained, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. In the event of one or more revisions to Rakuten Medical's forward-looking statement, it should not be inferred that such revisions or other forward-looking statements will be further revised.

SOURCE Rakuten Medical, Inc.

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Rakuten Medical Investigational Anti-cancer Therapy Candidate Seen to Activate Immune System Response and Synergize with PD1 Checkpoint Blockade in...

Immune response and cancer therapy, Science News, November 8, 1969

The dream of a cancer vaccine is still just that a dream. But experimenters at Emory University in Atlanta have shown that the basic mechanism stimulation of an immune response can take place.

Researchers have devised several ways of getting the immune system to prevent or control cancer. Vaccinations against human papillomavirus, or HPV, prevent infections that cause cervical and other cancers. Hepatitis B vaccines may head off some forms of liver cancer.

Other strategies, like CAR-T cell therapy and PD-1 blockade therapy (SN: 7/11/15, p. 14), prompt T cells of the immune system to go after tumors. The U.S. Food and Drug Administration approved the first PD-1 blockade therapy in 2011 and then two CAR-T cell therapies in 2017 for patients with certain types of cancers (SN: 12/23/17 & 1/6/18, p. 29). Overstimulating the immune system can produce severe side effects, so scientists are working to develop safer options (SN: 7/7/18, p. 22).

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50 years ago, cancer vaccines were a dream - Science News

Dublin-based Auranta has developed a range of animal feed additives which boost the immune system, reduce the need for antibiotics, and significantly reduce mortality. Not only do the additives improve the health of new-born and very young animals, they also enhance their performance in terms of weight gain and other key parameters throughout their lives.

The complementary animal feed products are produced from plant extracts and are designed for calves, poultry and pigs, under the AuraCalf, AuraPoultry and AuraShield brands.

Auranta managing director John Cullen explains the innovation by referring to AuraCalf. What we do is produce animal feed additives, he says. Dairy calves are weaned off milk after a couple of days and put on a milk replacer. Using our additives in the replacer boosts the animals gut health. The animals immune system is developed in the gut and how the animal performs over its life is directly related to the early development of the immune system.

A dairy calf is hugely dependent on what happens in the first few months of its life, he adds. How much milk it will produce is directly related to its health during the first two months. Scour and other infections will decide future performance. There is a lot of research to prove that. Our products are aimed at those first few months and go into very young animals.

He explains that the microbiome, the bacteria that inhabit the gut, is unique to every animal. Its like a fingerprint, he says. But when the animal is born there is nothing there. The gut gets colonised after birth.

It is this period of colonisation during which the microbiome is programmed for life that the Auranta product range targets. Our additives are a bit like probiotics, but they are not intended to kill anything. They protect the animal by giving a boost to the immune system. Most other products on the market try to mimic medication by killing pathogens in the gut but their ingredients kill good bacteria as well as bad.

The Auranta products are far more selective, however. They deal with the pathogens while protecting the good bacteria. The mechanism is quite complex but involves action on the gut wall which prevents the pathogens from attaching to it. We allow them go through and do no harm, but we dont do anything to stop the production of good bacteria.

This also helps reduce the use of antibiotics. There is nothing wrong with antibiotics, says Cullen. They are among the greatest discoveries in human history. But they can cause problems if they are overused. New legislation is coming in at the end of 2021 and farmers will not be allowed to use antibiotics to prevent infection or promote growth from them. At the moment, companies like McDonalds and KFC dont want antibiotics in the meat they buy.

Work started on the additives back in 2013. We had been looking at natural extracts from plants to improve the shelf life of food products and it wasnt too long before we started to look at nutritional products. We met with animal nutritionists and vets in the Far East and started looking at ideas for the animal feed area in 2014 and 2015. The lightbulb moment for us was when we found we could go in and just deal with the pathogens while keeping as many good bacteria alive as possible.

That saw the company begin work with Prof Nicolae Corcionivoschi of the Agriculture Food Biotech Institute in Belfast. He is a global expert in the animal microbiome and through him and our work with a group of Thai vets we started developing and testing products. We then carried out research to show what they were actually doing. Once we had the results we developed a product for use in animals.

AuraCalf was launched in 2018 and is now selling in eight markets with distributors appointed in 10 more and discussions ongoing with distributors in eight other countries.

Business is very good, says Cullen. Sales have doubled over the past year. Every penny we make goes back into product development. When we started out, we didnt have hard data to convince people we werent mad. Now that we have that data things are going very well. The calf product will do very well next year and we plan to introduce the poultry [product] in the Far East next year. We have some new products and enhancements in the pipeline, but we are going to stick to the knitting and build on what we have first.

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Auranta: Boosting the animal immune system - The Irish Times

In preparation for my recent trip to Ireland, I made sure I had my annual flu shot since I knew I would be in close quarters on the flight overseas. I very rarely get sick but figured I should error on the side of caution. Despite the flu shot, a combination of airplane air, change of climate, and one of my travel mates bringing her crud along for the trip, I ended up with some kind of chest cold.

Since my return I have tried just about everything to ditch this crud, from riding my Harley Davidson Softail really fast in order to blow the germs away, to sweating it out at CrossFit. I am happy to report that nearly two weeks later I can almost sleep through the night without coughing.

Cold season, unlike flu season, is really a 12-month affair. Anytime you get lots of people together in a space airplane, mall, movie theater, etc. chances are some of them have a cold and the germs are just waiting to jump on you.

Colds are the result of a viral infection, and there are several different types. The one that usually causes a cold in grown-ups like us is called the coronavirus and happens most often in early spring and winter. Colds cause sneezing, coughing, stuffy or runny nose and sometimes fever and chills. For the most part, colds will work their way out in three to five days, but some of the effects may linger longer.

If you are wondering about how colds affect our fitness routine, you are in the right place. Lets look at three questions regarding colds and fitness:

Does exercise prevent colds?

Regular exercise appears to have the advantage of being able to jump-start the immune system, and that can help reduce the number of colds you get. With exercise, the number and aggressiveness of certain immune cells, such as the ones called natural killer cells, increase by as much as 50% to 300%. If you exercise regularly, this temporary increase can help make the immune system more efficient at destroying intruders that cause illness such as colds. In one study reported in the American Journal of Medicine, women who walked for a half-hour every day for one year had half the number of colds as women who did not exercise. In this study, researchers associated regular walking with increasing levels of infection-fighting.

Does too much exercise make you catch a cold?

While for most of us over-exercising is not an issue, for some elite athletes it can be. Research indicates that athletes that participate in high-intensity sports marathon running, triathlons, etc. can actually get more colds. When an athlete trains too hard, the very white blood cells that help prevent illness decrease, leaving the body more vulnerable to getting sick. These ultra-athletes need to be aware and make sure they build in recovery days to their workouts to prevent illness.

Can you exercise with a cold?

Because exercise may help to boost immune function, its usually safe to exercise with a cold as long as you listen to your body. Sometimes cold medications, such as decongestants, can increase your heart rate. In addition, your heart rate is increased with exercise. The combination of exercise and decongestants can cause your heart to pump very hard. You may become short of breath and have difficulty breathing.

If you have a fever with a cold, exercise may stress your body even more. Thats why its important to wait a few days to get back to your regular exercise regimen. Working out too hard with a cold could stress your body, causing you to feel worse. This additional stress may hinder your recovery. It is best to back your exercise down a notch until you are 100%. Consult with your health-care provider if you have any questions or concerns about exercising while you are under the weather.

So there you have it. Exercise to prevent colds, keep exercising a little when you are under the weather, and dont work out so hard that your immune system crashes. My advice is to keep the hand sanitizer handy, dont drink behind your family or friends, and stay out of crowds until the sniffling season passes.

Kathy Hansen has more than 30 years of experience in the health and fitness field. She can be reached via e-mail at [emailprotected]

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411 on colds and exercise - The Robesonian

Fall and winter. The time of the year when it can feel like somebodys put a pox on your house.

First the little people drag home all those germs from their classrooms, then cortisol-ridden (the stress hormone) adults catch them and cart them off to work, where they spread the plague with co-workers. Its a vicious cycle until the world thaws out, the sun shines and were all spending more of our time outdoors and on vacation.

With the holidays and kids back in school and the weather changing, people have more stress and might not be sleeping as well as usual, says Dawn Franz, a nutritional health coach at Natural Grocers. Its important to ramp up your stress-coping toolbox. Supplements can support your immune system, as well as being able to balance your stress response.

And heres a more esoteric tip, if you tend to lean in that direction, as I do. Author and alternative medicine proponent Deepak Chopra has a way to reframe the narrative that I particularly like. When you feel that early symptom you know the one, maybe your nose is a little tingly and runny or your throat hurts first thing in the morning when it was fine the night before it means something is running amok in your body. This is the time to take those potions that help you fight off a virus, such as umcka or oil of oregano, two of my favorites. But Chopra says its not the time to lament to yourself and anyone within hearing distance that youre getting a cold and youll probably be out of commission for the next week. Instead, tell yourself your immune system is simply working overtime right now to fend off intruder germs, not that youre about to get sick. Its more proactive, less victim.

Here are six supplements to try over the next few months, as recommended by Franz. Take one or all of them as a daily tonic. If youre prone to getting sick, you might want to take the more, the merrier approach, but its not necessary, says Franz.

If youre under a lot of stress, do reishi and vitamin D-3, she says. Colostrum is good for athletes who put their body through a lot of stress. It keeps them healthy and from getting sick as frequently.

Be sure to give each supplement a fair shot. Franz suggests sticking to each for a month, and if you dont notice anything, try a different one. Though she likes to give her body a break from the supplements every now and again, she says its also OK to take them year-round. Come spring and summer, however, you might naturally feel a desire to go pill-free, if youre feeling good and not as stressed.

The mushroom is considered the queen of immunity by folks at Natural Grocers. Its been a staple of traditional Chinese medicine for more than 2,000 years, and is known for its ability to strengthen life force, calm the mind, help with sleep and treat and support respiratory conditions.

Reishi is the original chill pill, said Franz. It helps with the stress response and enhances the immune function and active immune function. There are a variety of ways to take reishi (pronounced ray-shee), including in tea, liquid extract, powder and capsules.

Mushrooms, in general, are a boon for your body, even those simple white button mushrooms you see at the grocery. Also good are shiitake and lions mane mushrooms.

Franz likes the Host Defense brand for mushrooms. The products are organic and grown in the U.S.

Yes, this is made from a milky fluid thats released from a cows udder after shes given birth. Try to not think about that too much, as according to some noteworthy studies, colostrum is a great friend to the immune system. It helps boost secretory IgA, which in turn increases the lining of our intestinal cells, one of our first lines of defense against pathogens. Its available in capsules, chewable pills and powder.

This amino acid complex is important for creating glutathione, an antioxidant that protects the cells and supports normal detoxification. It helps break up mucus in the lungs and works to protect tissue in the lungs and respiratory tract. Its mostly available in capsules. This supplement might be contraindicated with certain medications youre taking. Check with your doctor if you have concerns.

Reliable providers include Now and Carlson.

Every cell in your body has a receptor site for vitamin D. Its important for modulating how the immune system works, so its not over-reactive or under-reactive. When its over-reactive, you feel really sick. If its under-reactive ,youll get everything that comes around. Vitamin D regulates the immune system and acts as an antioxidant. You can get it in gels, liquids or chewables.

Especially in Colorado, even if you get out, you need UVB rays to create vitamin D in body, said Franz. But from November to February, we dont get UVB rays at our altitude. Its essential to supplement.

Reliable providers include Now and Carlson.

Theres a reason cranberries appear so regularly at this time of year: Theyre rich in the same compounds blueberries are known for, and have a regulatory affect on immune cells that primes them to fight off an infection. The compounds are beneficial to immune barriers, such as the gastrointestinal tract and mouth. You can drink tea or use it in its fresh or dried form. Allow it to inspire you to concoct organic cranberry sauce, but find a recipe that doesnt require sugar, which is definitely not a friend of the immune system.

This is the essential mineral that can be obtained by munching two to three Brazil nuts every day. Its important for immune function and helps the body fight off pathogens. Studies show a deficiency in selenium results in a decrease of the immune system to kill the yucky things. If you dont like the nuts, take it in pill form. Many multivitamins have it. Get about 200 micrograms per day.

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Live Well: Six supplements to boost immunity | Health - Colorado Springs Gazette

Matthew Wilson, Special to USA TODAY Published 10:01 p.m. ET Nov. 3, 2019 | Updated 10:09 a.m. ET Nov. 4, 2019

After 10 seasons and 2,000 pitches, 'Shark Tank' sharks talk about the best, worst and funniest pitches they've heard. Harrison Hill, USA TODAY

On Sundays Shark Tank, a physician was in need of treatment after he felt the wrath of two angry sharks.

Asking for $125,000 for 5% of his company, Sarath Malepati is the inventor of the EZC Pak, a five-day immune support pack made of echinacea, zinc and vitamin C. EZC Pak is a supplement thats supposed to boost the immune system and fight viruses.

As a general surgeon, Malepati said he has noticed increased overuse of antibiotics, which he said have no effect on viruses and can turn bacteria into antibiotic-resistant superbugs.

Over the last 10 years, Ive been dealing with a lot of complex infections, Malepati said. In the beginning, these infectionswe used to be able to treat with antibiotics. Now the antibiotics dont work.

According to Malepati, the cause is rooted in consumer-driven health care, which irked shark Mark Cuban, who was critical of his product.

That is so wrong in every which way, Cuban said. I know family history and what happened in the past is more indicative of what is going to happen to your future than almost anything. So knowing information about yourself is critical.

Sarath Malepati, a surgeon from Los Angeles, presented his formulated immune support pack designed to reduce unnecessary antibiotic use on "Shark Tank."(Photo: Eric McCandless, ABC)

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Malepati disagreed with Cubans assessment: I dont see how any of this is relevant to the patient walking in and requesting antibiotics and walking out with it.

Malepati and Cuban continued to trade barbs. You said part of the problem were facing in America today is a consumer-driven health care, Cuban said. So you think its a bad thing that consumers have more information about their health?

Malepati clarified his statement, saying he thinks products are marketed to consumers who may not have adequate health literacy to determine whether or not they are effective.

Holding up the EZC Pak, Cuban agreed: Thats why this (expletive) gets sold. Because thats why theres tons of these out there.

Shark Robert Herjavec came to Malepatis defense: I dont think thats fair, Mark. I think the way he said it is fair.

But it was obvious even as Malepati continued his pitch, his thoughts were still on Cuban. He drew the anger of shark Lori Greiner, a big zinc advocate, by ignoring her.

Why are you ignoring what Im saying? Thats odd to me. I am talking to you, and youre looking over at Mark, Greiner said. I was the customer. Ive been taking zinc for years. Im a believer in this. I am the one talking about antibiotic resistance and how important it is. But the fact that when I talk to you, you dont even look at me Im out.

Sarath Malepati, a surgeon from Los Angeles, presented his formulated immune support pack designed to reduce unnecessary antibiotic use on "Shark Tank."(Photo: Eric McCandless, ABC)

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Offended, Greiner cut off fellow shark Kevin OLeary, who was more interested in the companys sales than the drama unfolding in the tank. Malepati tried to apologize to her, but she wasnt ready to forgive.

As a woman in business, I think its very important for women to speak up for themselves and to stand up for themselves in a respectful way, Greiner said. I looked right at you maybe you were shaken by what Mark said, I dont know. But what I do know is when you came out here, you were looking at everybody else, not really me. I just sense some chauvinism here.

But guest shark Daniel Lubetzky thought Malepati didnt have an issue with women, he had an issue with Cuban. The two continued to argue, leading Herjavec to interject: Why are you poking the bear?

Despite the rocky pitch, OLeary decided to make Malepati an offer, in part because of the companys $1.2 million in sales for the past year with 80% margins. His offer was $125,000 for a 5% stake, with a royalty of 60 cents per unit in perpetuity.

Malepati countered with $125,000 for 5% but a $1 royalty per unit for 36 months. The two finally decided on a royalty of $1 per unit until OLeary made $450,000.

All right, doctor, OLeary said shaking Malepatis hand. Maybe it wasnt the most pleasant journey.

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'Shark Tank' recap: Doctor with virus-fighting supplement isn't immune to criticism - USA TODAY