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Moving Diabetes Upstream: the Social Determinants of Diabetes Management and Control Among Immigrants in the US – DocWire News

August 30th, 2020 7:55 pm

This article was originally published here

Curr Diab Rep. 2020 Aug 28;20(10):48. doi: 10.1007/s11892-020-01332-w.

ABSTRACT

PURPOSE OF REVIEW: Relative to the US-born population, immigrants are less likely to successfully manage and control their diabetes, leading to a host of diabetes-related complications. This review draws on the social determinants of health framework (SDoH) to summarize the multilevel factors that shape diabetes care and management among immigrants in the USA.

RECENT FINDINGS: While the diabetes literature is replete with research on individual-level risk factors and health behaviors, empirical literature linking the SDoH to diabetes management among immigrants is limited. However, housing precarity, food insecurity, poverty, uninsurance and underinsurance, and limited support for immigrants in healthcare systems are consistently shown to deter diabetes management and care. Immigrants with diabetes face a multitude of structural constraints to managing their diabetes. More research that theorizes the role of SDoH in diabetes management along with empirical qualitative and quantitative studies are needed. Interventions to address diabetes also require a more upstream approach in order to mitigate the drivers of diabetes disparities among immigrants.

PMID:32857197 | DOI:10.1007/s11892-020-01332-w

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Moving Diabetes Upstream: the Social Determinants of Diabetes Management and Control Among Immigrants in the US - DocWire News

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How to prevent gastroparesis, which can be caused by diabetes – The New Paper

August 30th, 2020 7:55 pm

Diabetes can affect many parts of the body over time and even lead to an undiagnosed condition known as gastroparesis when the spontaneous movement of the muscles in ones stomach does not function normally.

As such, it takes longer than it should for food to exit the stomach and travel further down the gastrointestinal tract.

Other times, the stomach may pass the food very quickly.

This unpredictability makes it difficult for patients with diabetes to know when to take insulin, and their blood sugar levels may get too high or too low at times, thus putting them at risk of diabetes-related complications such as kidney damage.

Chronic gastroparesis in diabetes patients can also result in symptoms going beyond nausea and vomiting, and cause pain and discomfort in the upper abdomen, leading to malnutrition and diminished quality of life. It can also cause their oesophagus to be inflamed, making swallowing difficult, if left untreated.

An overseas study has shown that gastroparesis affects 30 per cent to 60 per cent of those with type 1 diabetes, and approximately 30 per cent of those with type 2 diabetes.

Dr Andrew Ong, a consultant at Singapore General Hospitals department of gastroenterology and hepatology, said the hospital sees about five new diabetic gastroparesis cases a month.

However, he believes the number may be much higher as more Singaporeans are diagnosed with diabetes each year.

With August being Gastroparesis Awareness Month, Dr Ong shares more about the condition.

It is still under-diagnosed because there is a lack of awareness. To diagnose it, you need to do a gastric emptying test, which is not available in primary care when you visit the general practitioner.

There is also a lack of awareness among patients and doctors about this condition, primarily because there is a large overlap with symptoms from other common gut ailments such as gastritis or gastric pains.

Long-standing poor diabetic control and raised body mass index will increase the risk of diabetic patients developing gastroparesis.

Patients who suffer from other complications such as nerve damage, eye damage and kidney damage are also more likely to develop gastroparesis.

Though diabetes is the most common cause, others can include Parkinsons disease, post-viral illnesses and post-surgery cases.

Women are more likely to get gastroparesis. Diabetic gastroparesis patients tend to have type 1 diabetes in the younger patients, and long-standing type 2 diabetes in the older ones.

Strict sugar control and avoidance of medications that may trigger it, like opiates and anti-diarrhoeal medications.

Avoid foods that are high in fat and calories as these empty slower than foods with less. Eating many smaller meals and more in liquid forms such as porridge will also help reduce the symptoms.

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Tandem Diabetes Care Inc (NASDAQ:TNDM) Expected to Post Earnings of -$0.08 Per Share – MarketBeat

August 30th, 2020 7:55 pm

Wall Street analysts expect that Tandem Diabetes Care Inc (NASDAQ:TNDM) will report earnings of ($0.08) per share for the current fiscal quarter, according to Zacks. Six analysts have issued estimates for Tandem Diabetes Care's earnings. The highest EPS estimate is $0.05 and the lowest is ($0.18). Tandem Diabetes Care reported earnings per share of ($0.13) in the same quarter last year, which suggests a positive year-over-year growth rate of 38.5%. The company is expected to report its next earnings report on Monday, November 2nd.

According to Zacks, analysts expect that Tandem Diabetes Care will report full-year earnings of ($0.52) per share for the current year, with EPS estimates ranging from ($0.59) to ($0.43). For the next financial year, analysts expect that the company will post earnings of $0.02 per share, with EPS estimates ranging from ($0.47) to $0.33. Zacks Investment Research's EPS calculations are a mean average based on a survey of sell-side analysts that follow Tandem Diabetes Care.

Tandem Diabetes Care (NASDAQ:TNDM) last released its quarterly earnings data on Thursday, July 30th. The medical device company reported ($0.45) earnings per share (EPS) for the quarter, missing the Zacks' consensus estimate of ($0.24) by ($0.21). Tandem Diabetes Care had a negative return on equity of 12.88% and a negative net margin of 10.29%. The company had revenue of $109.24 million for the quarter, compared to analyst estimates of $86.51 million.

A number of research firms have recently commented on TNDM. Craig Hallum increased their target price on shares of Tandem Diabetes Care from $102.00 to $140.00 and gave the stock a "buy" rating in a research note on Friday, July 31st. Citigroup raised shares of Tandem Diabetes Care from a "neutral" rating to a "buy" rating and increased their target price for the stock from $94.00 to $120.00 in a report on Monday, July 6th. Piper Sandler upped their price target on Tandem Diabetes Care from $90.00 to $125.00 and gave the stock an "overweight" rating in a research note on Friday, July 31st. Lake Street Capital upped their price target on Tandem Diabetes Care from $125.00 to $137.00 and gave the stock a "buy" rating in a research note on Friday, July 31st. Finally, Cowen increased their target price on Tandem Diabetes Care from $85.00 to $110.00 and gave the company an "outperform" rating in a research report on Tuesday, July 7th. Six analysts have rated the stock with a hold rating and ten have given a buy rating to the company's stock. Tandem Diabetes Care has an average rating of "Buy" and an average price target of $112.57.

Wall Street legend who picked Apple in 2003 and Bitcoin in 2016 shares his #1 pick for 2020s.

Shares of NASDAQ:TNDM traded up $1.62 during trading on Friday, reaching $112.96. The stock had a trading volume of 518,729 shares, compared to its average volume of 873,327. The firm's fifty day moving average is $102.77 and its 200 day moving average is $84.08. The company has a debt-to-equity ratio of 0.80, a quick ratio of 4.18 and a current ratio of 4.72. Tandem Diabetes Care has a 52 week low of $43.69 and a 52 week high of $114.00. The stock has a market cap of $6.88 billion, a price-to-earnings ratio of -150.61 and a beta of 0.56.

In other news, Director Kim D. Blickenstaff sold 50,000 shares of the firm's stock in a transaction on Tuesday, June 30th. The stock was sold at an average price of $95.57, for a total transaction of $4,778,500.00. The sale was disclosed in a document filed with the SEC, which is accessible through this link. Also, CFO Leigh Vosseller sold 20,000 shares of the firm's stock in a transaction on Thursday, July 2nd. The shares were sold at an average price of $97.74, for a total value of $1,954,800.00. Following the transaction, the chief financial officer now owns 14,520 shares in the company, valued at approximately $1,419,184.80. The disclosure for this sale can be found here. In the last 90 days, insiders have sold 432,530 shares of company stock worth $44,983,347. Insiders own 6.00% of the company's stock.

A number of hedge funds have recently modified their holdings of the stock. Handelsbanken Fonder AB bought a new stake in Tandem Diabetes Care during the second quarter valued at about $1,029,000. Stephens Investment Management Group LLC boosted its position in Tandem Diabetes Care by 9.4% during the second quarter. Stephens Investment Management Group LLC now owns 619,124 shares of the medical device company's stock valued at $61,244,000 after purchasing an additional 53,112 shares in the last quarter. Copper Rock Capital Partners LLC bought a new stake in Tandem Diabetes Care during the second quarter valued at about $12,279,000. Gladstone Institutional Advisory LLC boosted its position in Tandem Diabetes Care by 17.4% during the second quarter. Gladstone Institutional Advisory LLC now owns 4,424 shares of the medical device company's stock valued at $438,000 after purchasing an additional 655 shares in the last quarter. Finally, AQR Capital Management LLC boosted its position in Tandem Diabetes Care by 9.4% during the second quarter. AQR Capital Management LLC now owns 41,487 shares of the medical device company's stock valued at $4,104,000 after purchasing an additional 3,579 shares in the last quarter. 91.73% of the stock is currently owned by institutional investors.

Tandem Diabetes Care Company Profile

Tandem Diabetes Care, Inc, a medical device company, designs, develops, and commercializes various products for people with insulin-dependent diabetes in the United States. The company's flagship product is the t:slim X2 insulin delivery system that comprises t:slim X2 pump, its 300-unit disposable insulin cartridge, and an infusion set.

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Vaughan doctor: ‘Majority of diabetic patients who experienced COVID-19 have done well’ – yorkregion.com

August 30th, 2020 7:55 pm

Askedif he had more patients trying to lose weight over the quarantine after Ontario declared a state of emergency on March 17, he said: It's been a mix.

Some people have actually gained weight, he said, describing how staying at home had made people snack more and be less active than usual.

Goldenberg noted emotional and stress eating is a big problem.

Others, however, seem to find more time to be active, and because of less stressful day to day routine.

Whether working from home or just being in the comforts of their own environment, others have found it easier to eat healthy.

Last year, Diabetes Canada showed how the rates of diabetes and prediabetes continue to rise.

With this new data, Diabetes Canada also unearthed how general knowledge of the disease was uncovered.

The study found that less than 50 per cent of all Canadians can identify less than half of the early warning signs of diabetes, only 33 per cent are aware that stroke is a complication of diabetes and only 40 per cent identified heart disease as a complication of diabetes.

In time of COVID-19, diabetes is considered to be an underlying condition, which could make diabetics face a higher rate of serious complications than those without it.

He also urged people to check diabetes.ca. He dubbed the website as very educational.

It's very, very helpful and often when patients call into our clinic and are worried we refer them on to that website.

So far, Goldenbergs clinic has a mixed model where about 40 per cent of his patients are now being seen live in the clinic and 60 per cent are still virtual visits.

He said its not a permanent model, but added: Even if the numbers are pretty small, until there's a vaccine, this new model is moving forward.

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Vaughan doctor: 'Majority of diabetic patients who experienced COVID-19 have done well' - yorkregion.com

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electroCore Announces Publication in Brain Stimulation Highlighting Non-Invasive Vagal Nerve Stimulations (nVNS) Potential Role in Treatment of…

August 29th, 2020 12:00 am

BASKING RIDGE, N.J., Aug. 27, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc.(Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a paper, entitled, Non-invasive vagal nerve stimulation decreases brain activity during trauma scripts1,by Wittbrodt, Bremner et. al. in the journalBrain Stimulation.

The paper reports on a double-blind sham-controlled study of nineteen participants who had experienced trauma but did not have the diagnosis of PTSD and highlights the ability of nVNS to decrease the fear associated with emotional stress. The authors hypothesized that nVNS could mitigate the stress associated with traumatic triggers compared to a sham device based on its ability to decrease the level of neural activity in areas of the brain believed to be responsible for the negative reaction.

Throughout several regions of the brain, stimulation with nVNS lead to significant (P<0.005) improvements in the brains ability to react to and process traumatic stimuli as measured by High Resolution Positron Emission Tomography (HR-PET). The data further suggests the activity of nVNS was seen immediately upon exposure to the traumatic stimuli and provided a benefit throughout the duration of emotional stress. The authors suggest that the results of this study provide evidence that nVNS may have utility as a treatment for many psychiatric disorders such as PTSD.

Dr. Doug Bremner, Professor of Psychiatry and Behavioral Sciences and Radiology at the Emory University School of Medicine and an author of the study, commented, Current treatments for PTSD, including medications and psychotherapy, have limitations. In fact, a report from the Institute of Medicine concluded that there is insufficient evidence for standard antidepressant treatments for PTSD. In light of that, new forms of treatment are needed, and non-invasive VNS is a good candidate that could be widely implemented in the field of psychiatry.

We compliment the authors on the publication of this rigorous research highlighting nVNS as a possible treatment for conditions like PTSD for which there are few well studied or available treatments, saidPeter Staats, MD, Chief Medical Officer of electroCore. We look forward to announcing additional grant supported studies in this area as they are initiated.

The paper is available via open access at:https://www.brainstimjrnl.com/article/S1935-861X(20)30199-6/fulltext

This work was sponsored by the Defense Advanced Research Projects Agency (DARPA) Biological Technologies Office (BTO) Targeted Neuroplasticity Training (TNT) program through the Naval Information Warfare Center (NIWC) Cooperative Agreement No. N66001-16-4054. See publication for disclosures.

About gammaCoregammaCore(nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patients neck over the vagus nerve, gammaCore stimulates the nerves afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared inthe United Statesfor adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in theEuropean Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache withinNHSEngland.

In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.

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Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patients neck, available under an emergency access mechanism called an EUA.

gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patients neck during the Coronavirus Disease 2019 (COVID-19) pandemic.

gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.

gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked.

Further information is available at:

Authorization Letter:https://www.fda.gov/media/139967/download

Fact Sheet for Healthcare Providers:https://www.fda.gov/media/139968/download

Fact Sheet for Patients:https://www.fda.gov/media/139969/download

Instructions for gammaCore usehttps://www.fda.gov/media/139970/download

About electroCore, Inc.electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The companys current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visitwww.electrocore.com.

Forward-Looking StatementThis press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects, sales and marketing, and product development plans, future cash flow projections, anticipated costs, its pipeline or potential markets for its technologies, the availability and impact of payer coverage, the potential product use for other indications, anticipated funding arrangements provided by theNHS, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCores business, sales and marketing, and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to successfully commercialize gammaCore, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with theSECavailable atwww.sec.gov.

Investors:Hans VitzthumLifeSci Advisors617-430-7578hans@lifesciadvisors.com

or

Media Contact:Jackie DorskyelectroCore973-290-0097

___________________________1 M.T. Wittbrodt et al. / Brain Stimulation 13 (2020) 1333-1348

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The pandemics of 1918 and 2020: What have we learned? – Fluvanna Review

August 29th, 2020 12:00 am

By Page H. GiffordCorrespondent

It is new and frightening, and Americans today have never witnessed or experienced anything like this pandemic. Our grandparents or great grandparents may have lived through the horrific death toll and economic impact of the 1918-1919 pandemic. But what was different? What have we learned?

Tricia Johnson, director of the Fluvanna County Historical Society, said the impact of the 1918 pandemic was devastating on Fluvanna residents. There were 8,500 residents of Fluvanna at the time and an estimated that 2,833 people were infected or about a third of the population. All told, 46 people died. (With COVID-19, to date, Fluvanna has 207 cases and nine deaths.)

Among the first fatalities in the 1918 pandemic were five Fork Union Military cadets all of whom died within four consecutive days. The fifth died later at home. Following this was the death of 72-year-old Sheriff Robert S. Campbell. The virus did not discriminate when it came to age.

Also, Alfred Lee Profitt of Shores, a W.W. I soldier discharged due to scrofula (a form of TB) died. His system was already compromised and along with complications of influenza, he died on December 10, 1918. He is buried in his family plot, which still exists today on private property off Shores Rd. not far from Caring for Creatures.

In Virginia in 1918, there were two million people and 326,000 were infected (15 percent) and 16,000 died. (With COVID-19, to date, Virginias 8.5 million in population has suffered 111,000 cases and 2,436 reported deaths.) By the end of the 1918 pandemic, 675,000 people lost their lives in the U.S. As of Aug. 23, deaths in this country has risen to slightly over 175,000.

In 1918, people had less contact than they do nowadays. Traveling meant walking, or riding on horseback; very few had cars though some traveled by train or ship. The most likely culprit in the spread of the 1918 pandemic was soldiers being discharged from overseas who had already contracted the disease. The FUMA cadets were not an isolated incident and not surprising when most of the infection rates were rampant among World War I soldiers returning home or in army camps.

There were three waves: the spring of 1918, the fall of 1918, and the spring of 1919. The second wave was most likely due to the Armistice Day (Veterans Day) celebration and the end of the war. That sounds familiar. In 2020, cases escalated due to Memorial Day and July 4th celebrations.

The public health response was swift and organized, but President Wilson, being preoccupied with a world war, never made a statement regarding the pandemic or its impact on the civilian population. The administration tried not to distract from the war effort which was responsible for the spread of the virus and increasing deaths. There were limited resources for the pandemic and unlimited resources given to the war effort.

There was a shortage of doctors with 30 percent serving in the armed services.

Not unlike where we are today, similar responses included uncertainty, fear, ignorance, and wishful thinking, influencing civilian and government behavior. In 2020, Americans are repeating some of the same behaviors.

Preventative measures were implemented by state and local governments, but officials were lacking transparency in communicating with the public, causing more widespread panic and fear and jeopardizing their credibility. In one example in 1918, in Chicago, when one hospital reached 40 percent capacity, the health commissioner announced, Worry kills more people than the epidemic. Experts agree that government transparency is key during a public health crisis. Denial may be a safer alternative but has been proven to make a situation worse.

Public Health Departments grew out of these advances and the belief in the ability of man to control nature. Sanitation, vaccination programs, and other public hygiene efforts in the late 19th century enabled public health officials to gain power and authority. However, the enormity of the 1918-1919 pandemic challenged the public health agencies. The massive death toll from the pandemic was puzzling and alarming. Many of the measures formerly known to work were ineffective. Lacking the organization and infrastructure and constrained by the war, they were unprepared for an event of this magnitude. Dr. Victor C. Vaughn, Dean of the University of Michigan School of Medicine, and adviser to the U.S Surgeon General during W.W. I, observing cramped hospital wards and flooded morgues, stated, Bodies stacked like cordwood.

Their aim was to reduce the transmission of the pathogen by preventing contact following the ancient guidelines of the past and like we do today. Back then, public health orders were based on scientific understanding of the microorganisms of influenza and how it is spread. Today, we do it the same way with scientific evidence. The conclusions are the same to prevent the spread of the disease.

The most frequently discussed and debated public health measure in the journals of the time was school closings. In the United States, school closure was not as widely accepted as it was in Europe. One article in the Journal of American Medical Association in 1918, stated that the desirability of closing schools in a large city in the presence of an epidemic is a measure of doubtful value. The American Public Health Association (APHA) debated the effectiveness of closing schools against the loss of educational studies. They believed school closings were thought to be less effective in large urban rather than in rural areas where the school represented the point of exposure of the infectious agent an ill-conceived idea considering spread was more prevalent among larger groups of people in closed areas in cities then isolated people in rural areas. The closing of schools and other public institutional to reduce the epidemic were not widely accepted. Many were in favor of herd immunity in Europe, believing, as we do today, that shutting everything down would cause greater unemployment and depression.

The more restrictive methods of infection control were quarantines and isolating those who were ill. Because of the strain on facilities, only severe cases were to be hospitalized while mild influenza patients were to remain at home. The APHA also supported institutional quarantines to protect people from the outside world in establishments like asylums and colleges, and military camps similar to our quarantine of long-term care facilities.

They set up hospital wards with social distancing, practiced good hygiene, and used disinfectants and sterilization methods. The JAMA describes in graphic detail the procedures for disinfecting areas from hospital beds to troop trains even to the placement of antiseptic hand solution in influenza wards. Today, its rubbing alcohol, Lysol, and Clorox. Nurses would wear special blouses inside the wards, removing them when the left to reduce transmission. A precursor of our PPE today in isolation wards.

There is little that separates us from the past in how we responded and proves history does repeat itself.

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Exosome Therapeutic Market (COVID 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 -…

August 28th, 2020 11:59 pm

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

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Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

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Competitive Landscape and Exosome Therapeutic Market Share Analysis

The major players covered in the report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

For More Insights Get FREE Detailed TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&pm

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

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Exosome Therapeutic Market (COVID 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 -...

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Exosome Therapeutic Market 2020-2026 with Covid-19 Impact Analysis || Major Gaints Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International…

August 28th, 2020 11:59 pm

Research and analysis about the key developments in the market, major competitors and detailed competitor analysis covered in this Exosome Therapeutic Market report helps businesses imagine the bigger picture of the market place which ultimately assists in defining superior business strategies. This report also provides notable data, present market trends, future events, market environment, technological innovation, forthcoming technologies and the technical advancement in the relevant industry. Exosome Therapeutic Market research report bestows clients with the best results and for the same it has been produced by using integrated approaches and latest technology.

Get Sample PDF (including COVID19 Impact Analysis) of Market Report @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-exosome-therapeutic-market&rp

The study conducted for Healthcare industry also analyzes the market status, growth rate, future trends, market drivers, opportunities and challenges, risks and entry barriers, sales channels, and distributors with the help of SWOT analysis and Porters Five Forces Analysis. It all-inclusively estimates general market conditions, the growth prospects in the market, possible restrictions, significant industry trends, market size, market share, sales volume & future trends. This Exosome Therapeutic Market report has been prepared with the combination of steps which employs a nice blend of industry insights, practical solutions, and latest tools and technologies.

Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in theExosome Therapeutic Marketreport areevox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global.Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Get Full TOC, Tables and Figures of Market Report @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&rp

Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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About Data Bridge Market Research :

Data Bridge Market Researchis a versatile market research and consulting firm with over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies globally and have a network of more than 5000+ clientele around the globe. Our coverage of industries include Medical Devices, Pharmaceuticals, Biotechnology, Semiconductors, Machinery, Information and Communication Technology, Automobiles and Automotive, Chemical and Material, Packaging, Food and Beverages, Cosmetics, Specialty Chemicals, Fast Moving Consumer Goods, Robotics, among many others.

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Exosome Therapeutic Market 2020-2026 with Covid-19 Impact Analysis || Major Gaints Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International...

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Equipping the Immune System to Fight Against COVID-19 – BioSpace

August 28th, 2020 11:57 pm

The coronavirus that causes COVID-19 has one major advantage over us it is a new human virus. Most people have not encountered the virus before, meaning their immune system is not primed and ready to fight it. When someone gets sick with COVID-19, there is a lag in an efficient immune response, giving the virus time to do significant damage before the immune system can reign in the infection.

It essentially becomes a race between how fast your immune system can clear the virus and how quickly the virus can replicate and induce damage, Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences at AlloVir, told BioSpace.

To develop an effective treatment or vaccine for COVID-19, scientists must understand how the immune system is impacted during the disease. One type of immune cell that is particularly important in the bodys response to COVID-19 is T-cells. T-cells perform many functions, including recognizing invading viruses such as the coronavirus that causes COVID-19.

Multiple studies from Wuhan, China reported that COVID-19 patients had very low T-cell counts; the sicker the patient, the lower their T-cell count. Lower T-cell counts were correlated with poorer outcomes (including higher risk of death) and T-cells isolated from COVID-19 patients also showed signs of exhaustion.

The elderly, patients with low T-cell numbers, and patients who express exhaustion markers on their T-cells are high risk groups in which nave cell responses (responses against a virus they have never seen before) may be deficient or delayed, thus allowing the virus to induce a large amount of damage, Dr. Melian explained. These patients may, therefore, benefit from AlloVirs approach which is designed to restore natural T-cell immunity in high risk patients.

Could giving high-risk COVID-19 patients functional T-cells against the coronavirus boost their immune system and help them recover? This is the question AlloVir aims to answer.

AlloVir creates allogeneic (off-the-shelf) virus-specific T-cells designed to treat common and devastating viral-associated diseases in vulnerable patients, such as those who are immunocompromised or patients who received an organ or stem cell transplant. Now, they are expanding their anti-viral T-cell arsenal and taking aim at COVID-19.

We believe AlloVirs technology is well positioned to treat patients with COVID-19 because our technology is designed to provide SARS-CoV-2 specific T-cell immunity while leaving non-infected cells intact, Dr. Melian commented. Our virus-specific T-cell candidates have been used to treat more than 275 immunocompromised patients with life-threatening viral infections and diseases and we believe it our approach may also have promise in treating COVID-19.

Fighting viruses with T-cells in immunocompromised patients

When you get infected with a virus, your immune system responds to the foreign threat by making specific T-cells that can recognize the virus. These specific T-cells prompt your immune system to destroy any cells infected by the virus.

However, if you have a T-cell deficiency, your immune system cannot robustly protect you. This is a major problem because an otherwise innocuous virus can become a serious infection, causing complications, and possibly even be life-threatening.

That is where AlloVir comes in. They address the underlying problem the weakened immune system. A weakened immune system can be beefed up by giving patients with T-cell deficiencies off-the-shelf virus-specific T-cells (VSTs) originally taken from healthy people. This restores their natural T-cell immunity and helps their immune system fight off the viruses.

At AlloVir, we are a leading innovator in discovering and developing allogeneic, virus-specific T-cell immunotherapies, Dr. Melian said. We are now excited to be applying our capabilities in discovering and developing SARS-CoV-2 specific T-cells to join the fight in developing a COVID-19 program for patients at high risk of severe and devastating disease.

AlloVirs virus-specific T-cell platform

To create AlloVirs T-cell therapies, the target virus is first studied carefully to identify its specific antigens (unique molecules on the outside of each virus that are specific to the virus and alert the immune system). The best antigens those that induce a strong T-cell response are used to create the therapy.

Next, blood is taken from healthy donors who have been exposed to the virus of interest and T-cells are isolated from the blood. The T-cells are activated in the lab they are trained to recognize the identified viral antigens, enabling the T-cells to selectively recognize only the desired virus.

After the T-cells have learned to recognize the specific virus, they are expanded to generate multitudes of cells. Once the activated, specific T-cells are created, they can be cryopreserved and kept for a long time, making them readily available as soon as a patient needs them. The entire process, from antigen selection to donor to ready-to-go T-cell treatment, can be completed in a matter of weeks. This process can be seen in the visual below.

Source: AlloVir

Patients are matched using the companys proprietary human leukocyte antigen (HLA)-matching formula. HLAs are proteins on the surface of cells that regulate the immune system.

Our proprietary donor selection algorithm, known as Cytokin enables us to cover >95 percent of patients in our target population from cells derived from a small number of donors, Dr. Melian said. This proprietary process of prospectively manufacturing cells for off-the-shelf use enables us to study our allogeneic cell therapies in large numbers of patients that suffer from global health crises, like seasonal influenza and, as we are discussing, the COVID-19 pandemic.

These T-cells are advantageous because they are active against a single virus or multiple viruses, are not patient-specific (so they are readily available) and are a single treatment that provides lasting protection. The biggest bonus is the immediate off-the-shelf use for time-sensitive infections in vulnerable populations, added Dr. Melian.

In addition to developing their COVID-19 therapy (called ALVR109), AlloVir has two other multi-virus specific T-cell therapies in development: Viralym-M (ALVR105) and ALVR106. Both therapies focus on treating viral diseases common to stem cell and solid organ transplant patients and other vulnerable populations.

Viralym-M targets six common viruses: BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV, also called human herpesvirus 4), human herpesvirus 6, and JC virus (also called human polyomavirus 2). Although these viruses are widespread and infect most people, they only cause severe problems in people with weakened immune systems due to age, organ or stem cell transplant, or disease (such as diabetes or AIDS). In a Phase 2 study, 93 percent of 38 allogeneic stem cell transplant patients had a clinical response to Viralym-M treatment and functional Viralym-M cells lasted up to 12 weeks in the patients.

ALVR106 targets four common respiratory viruses: influenza, parainfluenza virus, respiratory syncytial virus (RSV), and human meta-pneumovirus (HMPV). While these viruses tend to cause mild to moderate respiratory illnesses, they can cause severe, life-threatening illness, especially in people with weakened immune systems. ALVR106 is still in preclinical development but clinical trials are expected to begin this year. Overall, AlloVir expects to have three new proof-of-concept (POC) Phase 1b/2 and three pivotal Phase 3 studies started over the next 6-18 months.

Off-the-shelf T-cells against COVID-19

While AlloVir originally designed their T-cell therapies for transplant patients, their platform can potentially be applied to any virus to create virus-specific T-cells. This versatility allowed AlloVir to pivot and create T-cells against SARS-CoV-2, the virus that causes COVID-19. This new investigational therapy, called ALVR109, is being developed as a stand-alone treatment, though it may also be incorporated into their ALVR106 respiratory virus therapy at some point in the future.

Normally, the body would make virus-specific T-cells on their own and these would clear the virus, commented Dr. Melian. We enable that process in patients who otherwise would be T-cell deficient to restore T-cell immunity by giving ex vivo expanded cells that come from patients who already have demonstrated a potent immune response and have cleared the infection.

The process of creating coronavirus-specific T-cells is the same as creating their other virus-specific T-cell therapies. First, blood is taken from people who have recovered from COVID-19 and the T-cells are isolated. Then, the cells are stimulated with viral antigens in the lab, expanded, and cryopreserved.

We purposely choose a broad range of viral antigens to stimulate the T-cells to ensure the virus cant circumvent the virus-specific T-cell therapy by mutating or developing resistance, Dr. Melian said. Working with a wide spectrum of viral activity is different than other approaches that just focus on one viral antigen.

An open-label Phase 1 trial (called BAT IT) is anticipated to start within the next few months. Initial clinical studies of ALVR109 aim to treat high-risk COVID-19 patients, such as the elderly, to prevent organ damage. Prophylaxis studies, where the T-cells could be given to high-risk or immunocompromised patients who are not currently sick with COVID-19, may be considered later.

Coronavirus-specific T-cells vs. COVID-19 convalescent plasma

You may be wondering if another treatment that uses blood from COVID-19 survivors, called convalescent plasma therapy, is similar to AlloVirs T-cell therapy. In convalescent plasma treatment, antibodies from COVID-19 survivors are isolated from their blood by separating out their plasma (the liquid part of the blood). The plasma is given to COVID-19 patients to help their immune system fight off the infection.

Although convalescent plasma and AlloVirs coronavirus-specific T-cell treatments are both derived from COVID-19 survivors blood, the two treatments are fundamentally different.

Antibodies and T-cells work in different areas of the immune system, explained Dr. Melian. Antibodies can go after viruses in circulating blood but cant necessarily see viruses in infected cells. On the other hand, T-cells are pleotropic and directly attack virally infected cells, turning off the viral factories. T-cells are interesting because it is a live therapy they can home to virally-infected cells and direct the immune system.

Dr. Melian went on to explain that T-cell approach may be more comprehensive because they can support other immune cells that work against viruses, such as B-cells that make viral-specific antibodies. T-cells can also stimulate cytokines including interferon (a group of signaling proteins the immune system uses to respond to viruses), which further activates the bodys antiviral response.

Providing virus-specific antibodies may be beneficial and protective for some viral infections, Dr. Melian added. We dont know how these antibodies affect COVID-19 patients yet, but COVID-19 has a high mortality rate despite standard of care treatment. In this respect, it is important that all viable approaches to treatment be evaluated and I am very pleased to see these therapies have entered clinical testing.

Convalescent plasma and AlloVirs coronavirus-specific T-cell therapies are not mutually exclusive, so they could even be used together.

More:
Equipping the Immune System to Fight Against COVID-19 - BioSpace

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10 Foods and Vitamins That Can Help Boost Your Immune System – South Florida Caribbean News

August 28th, 2020 11:57 pm

When our immune systems are fatigued by stress, inflammation, and poor nutrition, we feel tired and sluggish on a daily basis. Its hard to get out of bed even when we arent fighting a bug. Conversely, when our immune systems have the proper dietary support, they can fight off invading pathogens and help us recover more quickly.

What can you really do to boost your immunity? Nourish your body with healthy vitamins and foods.

Yes, thats all there is to it. When your body has the chemical compounds, it needs to synthesize white blood cells, repair cellular damage, and bounce back, your immune system is in peak form.

Below, well share our ten favorite foods and vitamins for improving immunity.

Fragrant orange turmeric is a staple of many healthy world cuisines.

Turmeric is powerfully anti-inflammatory thanks to the compound curcumin. What does that mean?

When your body responds to illness or stress by creating inflammation, your stress hormone levels rise, and your immune system goes on high alert. Soothing turmeric can help with chronic inflammation caused by insomnia, poor diet, and other factors.

Its also a great addition to curries, stews, and even grains.

When you lack Vitamin C, you get scurvy. What happens next? Your gums bleed, and your wounds dont heal. Its unpleasant, to say the least.

Vitamin C is crucial for cell repair and tissue healing. It can help with everything from post-exercise fatigue to the common cold.

How can you get it?

Garlic is a common folkloric cure for colds. Highly antibacterial and antifungal, its not just a great seasoning, but also a potent aid to your immune system. Try using the following in cooking:

Alternately, you can dip garlic cloves in honey and eat them raw. It may give you garlic breath, but we think its worth it.

Vitamin B6 helps your body synthesize red blood cells and neurotransmitters. Its most often found in:

You can also take it in a supplement.

Medicinal mushrooms are perhaps the next frontier of health. Long used in Traditional Chinese Medicine to promote longevity, shiitakes may also help your immune system to function well. These mushrooms are available at many grocery stores, or you can grow your own.

Bright, spicy ginger is a great addition to recipes from curry to ceviche. Better yet, its anti-inflammatory and antioxidant.

Ginger is also a traditional remedy for:

Pearl powder may not seem like a foodwe usually think of eating oysters, not their pearls! Indeed, pretty, translucent pearl powder is often found in skin care because of its nourishing properties.

However, pearl powder is full of:

These qualities make it the latest entrant to the hall of superfood fame.

Youve probably applied topical Vitamin E to cuts and scrapes. You also need plenty in your diet to support healthy immunity. Its vital for preventing the healthy flow of blood throughout the body, and your immune systems white blood cells need fast passage via the bloodstream to the site of any infection.

Find Vitamin E in:

Rich in antioxidants, elderberry syrup is a popular supplement for promoting immunity and heart health. In fact, its one of the most commonly used medicinal plants in the world!

You can also take it in a capsule, or find it in teas, gummies, and even lollipops.

While less exotic than some of the entrants on this list, green, leafy spinach is packed with beneficial nutrients:

Dont like to eat your greens? Throw it in the blender with some fruit and pretend its not there!

If you need more motivation to incorporate these healthy foods into your cooking repertoire, consider putting together a meal for friends and family. After all, healthy relationships actually help boost your immunity and overall health, too.

When it comes to supplements, make sure to use them daily to experience improved results over time.

Hopefully, your new routine helps you feel stronger and more ready for whatever comes your way.

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10 Foods and Vitamins That Can Help Boost Your Immune System - South Florida Caribbean News

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4 Essential Vitamins and Minerals to Boost Your Immune System This Year – MSN Money

August 28th, 2020 11:57 pm

Cold and flu season always has us restocking our vitamin C supplies, but this year, as the pandemic continues and with the threat of a coronavirus-and-flu "twindemic" on the horizon, immune system health has become particularly important. (Quick PSA to get your flu shot.)

If you're looking into vitamins, minerals, and supplements to boost your immune system, go for it - but remember to do your research first. "For these kinds of questions, the gold standard of truth is the randomized controlled trial," said John Mafi, MD, MDH, an assistant professor of medicine in the Division of General Internal Medicine and Health Services Research at the David Geffen School of Medicine at UCLA. "While it's complicated to directly measure immune system strength, a good marker for it is how often or how long you get colds and flu viruses."

Ahead, we've rounded up a few of the vitamins and supplements that have proven benefits to your immune system so you can stock up as cold weather approaches.

-Additional reporting by Maggie Ryan

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4 Essential Vitamins and Minerals to Boost Your Immune System This Year - MSN Money

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Several have been reinfected with Covid-19. Here’s what that means – STAT

August 28th, 2020 11:57 pm

Following the news this week of what appears to have been the first confirmed case of a Covid-19 reinfection, other researchers have been coming forward with their own reports. One in Belgium, another in the Netherlands. And now, one in Nevada.

What caught experts attention about the case of the 25-year-old Reno man was not that he appears to have contracted SARS-CoV-2 (the name of the virus that causes Covid-19) a second time. Rather, its that his second bout was more serious than his first.

Immunologists had expected that if the immune response generated after an initial infection could not prevent a second case, then it should at least stave off more severe illness. Thats what occurred with the first known reinfection case, in a 33-year-old Hong Kong man.

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Still, despite what happened to the man in Nevada, researchers are stressing this is not a sky-is-falling situation or one that should result in firm conclusions. They always presumed people would become vulnerable to Covid-19 again some time after recovering from an initial case, based on how our immune systems respond to other respiratory viruses, including other coronaviruses. Its possible that these early cases of reinfection are outliers and have features that wont apply to the tens of millions of other people who have already shaken off Covid-19.

There are millions and millions of cases, said Michael Mina, an epidemiologist at Harvards T.H. Chan School of Public Health. The real question that should get the most focus, Mina said, is, What happens to most people?

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But with more reinfection reports likely to make it into the scientific literature soon, and from there into the mainstream press, here are some things to look for in assessing them.

Whats the deal with the Nevada case?

The Reno resident in question first tested positive for SARS-CoV-2 in April after coming down with a sore throat, cough, and headache, as well as nausea and diarrhea. He got better over time and later tested negative twice.

But then, some 48 days later, the man started experiencing headaches, cough, and other symptoms again. Eventually, he became so sick that he had to be hospitalized and was found to have pneumonia.

Researchers sequenced virus samples from both of his infections and found they were different, providing evidence that this was a new infection distinct from the first.

What happens when we get Covid-19 in the first case?

Researchers are finding that, generally, people who get Covid-19 develop a healthy immune response replete with both antibodies (molecules that can block pathogens from infecting cells) and T cells (which help wipe out the virus). This is what happens after other viral infections.

In addition to fending off the virus the first time, that immune response also creates memories of the virus, should it try to invade a second time. Its thought, then, that people who recover from Covid-19 will typically be protected from another case for some amount of time. With other coronaviruses, protection is thought to last for perhaps a little less than a year to about three years.

But researchers cant tell how long immunity will last with a new pathogen (like SARS-CoV-2) until people start getting reinfected. They also dont know exactly what mechanisms provide protection against Covid-19, nor do they know what levels of antibodies or T cells are required to signal that someone is protected through a blood test. (These are called the correlates of protection.)

Why do experts expect second cases to be milder?

With other viruses, protective immunity doesnt just vanish one day. Instead, it wanes over time. Researchers have then hypothesized that with SARS-CoV-2, perhaps our immune systems might not always be able to prevent it from getting a toehold in our cells to halt infection entirely but that it could still put up enough of a fight to guard us from getting really sick. Again, this is what happens with other respiratory pathogens.

And its why some researchers actually looked at the Hong Kong case with relief. The man had mild to moderate Covid-19 symptoms during the first case, but was asymptomatic the second time. It was a demonstration, experts said, of what you would want your immune system to do. (The case was only detected because the mans sample was taken at the airport when he arrived back in Hong Kong after traveling in Europe.)

The fact that somebody may get reinfected is not surprising, Malik Peiris, a virologist at the University of Hong Kong, told STAT earlier this week about the first reinfection. But the reinfection didnt cause disease, so thats the first point.

The Nevada case, then, provides a counterexample to that.

What kind of immune response did the person who was reinfected generate initially?

Earlier, we described the robust immune response that most people who have Covid-19 seem to mount. But that was a generalization. Infections and the immune responses they induce in different people are heterogeneous, said Sarah Cobey, an epidemiologist and evolutionary biologist at the University of Chicago.

Older people often generate weaker immune responses than younger people. Some studies have also indicated that milder cases of Covid-19 induce tamer immune responses that might not provide as lasting or as thorough of a defense as stronger immune responses. The man in Hong Kong, for example, did not generate antibodies to the virus after his first infection, at least to the level that could be detected by blood tests. Perhaps that explains why he contracted the virus again just about 4 1/2 months after recovering from his initial infection.

In the Nevada case, researchers did not test what kind of immune response the man generated after the first case.

Infection is not some binary event, Cobey said. And with reinfection, theres going to be some viral replication, but the question is how much is the immune system getting engaged?

What might be broadly meaningful is when people who mounted robust immune responses start getting reinfected, and how severe their second cases are.

Are people who have Covid-19 a second time infectious?

As discussed, immune memory can prevent reinfection. If it cant, it might stave off serious illness. But theres a third aspect of this, too.

The most important question for reinfection, with the most serious implications for controlling the pandemic, is whether reinfected people can transmit the virus to others, Columbia University virologist Angela Rasmussen wrote in Slate this week.

Unfortunately, neither the Hong Kong nor the Reno studies looked at this question. But if most people who get reinfected dont spread the virus, thats obviously good news.

What happens when people broadly become susceptible again?

Whether its six months after the first infection or nine months or a year or longer, at some point, protection for most people who recover from Covid-19 is expected to wane. And without the arrival of a vaccine and broad uptake of it, that could change the dynamics of local outbreaks.

In some communities, its thought that more than 20% of residents have experienced an initial Covid-19 case, and are thus theoretically protected from another case for some time. That is still below the point of herd immunity when enough people are immune that transmission doesnt occur but still, the fewer vulnerable people there are, the less likely spread is to occur.

On the flip side though, if more people become susceptible to the virus again, that could increase the risk of transmission. Modelers are starting to factor that possibility into their forecasts.

A crucial question for which there is not an answer yet is whether what happened to the man in Reno, where the second case was more severe than the first, remains a rare occurrence, as researchers expect and hope. As the Nevada researchers wrote, the generalizability of this finding is unknown.

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Declining antibodies and immunity to COVID-19 why the worry? – The Conversation US

August 28th, 2020 11:57 pm

Most people are aware that testing for antibodies in a persons blood can show if someone has had a specific disease, such as COVID-19. Those antibodies provide protection from getting the disease again.

But in a paper published in the New England Journal of Medicine, researchers found that antibody levels decline in individuals who have recovered from COVID-19, dropping by half every 36 days. Does that mean people who have recovered from COVID-19 have lost their immunity?

I am a geneticist interested in innate immune response the part of the immune system that we have at birth and how the innate immune cells educate antibody-producing cells about a pathogen and how to identify and destroy it. As Ill explain, antibodies are important for immunity, but they arent the only factor that counts.

The immune system is made up of two parts: innate immunity and adaptive or acquired immunity.

The innate immune system, which includes white blood cells called dendritic cells, monocytes and neutrophils, is present at birth and responds instantly to invaders. This group of white blood cells bombard pathogens with destructive chemicals and swallow and destroy viruses and bacteria. The innate immune system provides an instantaneous reaction to a pathogen. The problem is that its a blunt instrument it responds the same way to all perceived threats.

The adaptive immune system, which is made up of B cells and T cells, must learn about a pathogen and its characteristics from the innate immune cells. This system takes longer to kick in, but the up side is that it is very specific and in many cases lasts a lifetime.

The history of pathogen exposure is carried in so-called memory T cells and memory B cells. When an infection is defeated and gone, these cells reside in the peripheral tissues of the body such as lymph nodes or spleen and serve as a memory of the disease-causing virus. This immunological memory is responsible for the host defense and kicks into action in case of the second wave or attack of the pathogen.

It is normal for antibody levels to decline after a person has recovered from a disease. But the New England Journal of Medicine paper raised concerns because it suggests that we are losing our immunological memory which is as bad as losing a real memory.

B cells and antibodies are only part of the immune response. T cells help B cells produce antibodies which are proteins that can bind to a specific pathogen and destroy it.

The way this happens is that first the B cells swallow the virus and start producing antibodies.

T cells cannot swallow the virus. But a type of white blood cell called an antigen-presenting cell can. After it does, it shows different parts of the virus to the T cells. The T cells then learn about the virus which they can now seek and destroy.

T cells also stick to the B cells and send them the activation signals that help B cells ramp up antibody production.

It suggests that when there are fewer antibodies in the blood, there is a greater chance that a number of individual virus particles, called virions, will survive and escape destruction. Therefore, the remaining virions will continue to proliferate and cause disease.

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Herd immunity refers to a population and occurs when a sufficiently high number of people within a community are immune to the virus and incapable of transmitting it. That provides protection for those who are still vulnerable. For example, if 60% of people are protected against COVID because they have survived the infection and carry antibodies it might protect (via less frequent interactions) the remaining 40% from getting sick.

But the results in the New England Journal of Medicine suggest that people with lower levels of antibody may still have the virus and may not have symptoms of the disease.

That means that if these people with low antibody levels hang around healthy, uninfected people, they present a danger to them because they can transmit the virus.

In general, the answer is no. If the virus attempts to cause a second infection, the memory B and T cells are able to recognize it, multiply million of times and defend the body against the virus, preventing it from triggering another full-blown infection.

The protection provided by memory T and B cells is the reason that vaccine-based protection works.

However, there are exceptions. A lifelong vaccine against the flu does not work because flus genetic code changes rapidly, altering the appearance of the flu, and therefore requires a new vaccine every season.

But with SARS-CoV-2, the problem as I see it, seems to be that those memory T cells and B cells seem to be wiped out.

Antibodies are proteins and last for only between three and four weeks in the blood circulation. To keep antibody levels high, B cells need to replenish them with a fresh supply. But in COVID-19, the declining antibody levels suggest that the cells that produce these antibodies are not present in sufficient numbers, which would explain the drop in antibody levels. Studies of how long immunity from COVID-19 last may shed more light, but for now we do not know the reason why.

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The 21-day plan to support your immune system and help fight off infections – Telegraph.co.uk

August 28th, 2020 11:57 pm

Something that gave me an even greater incentive to write my book, The 21 Day Immunity Plan, was the premature deaths of two family members who suffered and died because of a compromised immune system.

My older brother, Amit, died of a virus that affected his heart at the age of 13. Born with Downs syndrome, his compromised immune system was genetic and there was little that could have been done to prevent his death from crashing heart failure when he caught a tummy bug that most people would have been able to fight off.

The second was my mother, who over the four-week period of her final admission to hospital endured indescribable pain from an infection that affected her spine. Her compromised immune system was almost entirely rooted in lifestyle choices. Because the NHS was already overstretched, a heart attack was missed, treatment was delayed and she gasped for breath as fluid engulfed her lungs. Eventually she slipped into a coma as the infection spread through her body, and she passed away aged only 68.

Beyond my observations as a medical scientist and my duties as a clinical doctor to share knowledge on the link between metabolic health and immunity, I wrote my book from the perspective and motivation of someone who has had to deal with all the emotion and sadness of seeing a close family member die well before their time and in the most horrible of circumstances. No one needs to suffer like she did and no family member should have to witness it.

What Covid-19 has also done is expose areas in our health systems and personal well-being that have long been neglected, and which in themselves have made us more vulnerable to such a particularly pernicious virus. But in spite of the tragedy, the disturbing statistics and heartbreaking stories that have collectively gripped the world, we can draw from the lessons the virus has taught us and look to a brighter future.

The 21-day immunity plan is one that involves nutritious food, helps to regulate and reduce inflammation, combats insulin resistance and improves overall metabolic health. It should be enjoyable and be in keeping with all cultures and personal preferences.

It will help you to:

Over the course of the three weeks, you will follow an eating plan, you will be required to move your body daily, carry out breathing exercises, monitor and improve your sleep habits and be seeking to reduce your stress and improve your mental well-being by making a concerted effort to nurture and celebrate time with friends and family.

Please note that if you suffer from type 2 diabetes, high blood pressure or heart disease and more specifically are taking medications, you must consult your doctor before starting the 21-day plan, as medication is likely to need adjusting/reducing and may potentially need to be stopped altogether.

We know that prolonged sitting and being more sedentary in general increases the risk of heartdisease, high bloodpressure and type 2 diabetes.

Regular cardiovascular exercise has the strongest evidence base when it comes to reducing the risk of many diseases. It has even been shown to significantly reduce insulin resistance within three months for those who start off with a sedentary lifestyle, even without weight loss.

Throughout the three weeks of this plan, I want you to go for a brisk walk for at least 30 minutes on five days each week. Subjectively, this is where you feel a bit out of breath to the point youre able to have a conversation but youll find it difficult to sing.

If you want to be very precise, then measuring your heart rateprovides a more objective measure of activity intensity.

You want to aim to get your heart rate within a range of 50 to 70 per cent ofyour maximum, which isrelated to your age. Thereason for this heart-rate range is based on numerous studies which reveal beneficial physiological changes in thebody startto occur once you exerciseat this level, including reduced insulinresistance.

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Exercise may boost your vaccine response – The Indian Express

August 28th, 2020 11:57 pm

By: New York Times | Published: August 28, 2020 9:31:47 amThe two studies, which involved the same group of elite runners, swimmers, wrestlers, cyclists and other athletes, suggest that intense training amplifies our vaccine response. (PTI/File)

Written by Gretchen Reynolds

Two new studies of elite athletes found that working out amplifies the immune response to a flu shot.

If you are an athlete, you may gain greater immunity from a flu shot than people who are less active, according to two complementary and timely new studies of exercise and vaccinations. The two studies, which involved the same group of elite runners, swimmers, wrestlers, cyclists and other athletes, suggest that intense training amplifies our vaccine response, a finding with particular relevance now, as the flu season looms and scientists work to develop a COVID-19 vaccine.

Having an immune system primed to clobber infections and respond robustly to vaccinations is obviously desirable now, during the ongoing pandemic. And in general, exercise aids immunity, most science shows. People who work out often and moderately tend to catch fewer colds and other viruses than sedentary people. More immediately, if you exercise your arm in the hours before a flu shot, you likely willdevelop a stronger antibody responsethan if you rest that arm, a few small studies indicate.

But there have also been suggestions that under certain circumstances, exercise may dampen the immune response. Some epidemiological research and personal stories from athletes hint that intense, exhausting exercise might be detrimental to immunity in the short term.Marathon racers, for example, report catching colds at disproportionately high rates soon after a race, although some physiologists suspect thesepost-race respiratory problems are inflammatory, not infectious.

The upshot, though, is that many questions have remained unanswered about whether and how strenuous workouts affect immunity and our bodies ability to respond favorably to a vaccination, such as the seasonal flu shot.

So, for the new studies, scientists from Saarland University in Germany and other institutions decided to convince a large group of competitive athletes to get vaccinated, an effort more difficult than most of us might expect. In surveys, elite athletes tend to report relatively low rates of vaccination for the flu and other conditions, since many worry the shot will cause side effects that affect their training.

But the researchers managed to recruit 45 fit, young, elite athletes, male and female. Their sports ranged from endurance events, like the marathon, to power sports, including wrestling and hammer throw, to team sports, such as basketball and badminton. All of the volunteers were in the middle of their competitive seasons during the studies.

For the first of the two experiments involving these athletes, which waspublished in January in Brain, Behavior, and Immunity, the researchers hoped to establish whether being an athlete and having an athletes outsized fitness would goose or impede the young peoples immune reaction to a flu shot. So, the scientists also recruited an additional 25 young people who were healthy but not athletes to serve as a control group. They drew blood from everyone.

Afterward, all of the young people received a flu shot and kept notes about any side effects they felt, such as a sore arm. The groups returned to the lab for follow-up blood draws a week, two weeks and six months after the vaccination. Then the researchers checked their blood for anti-influenza immune cells and antibodies.

They found significantly more of those cells in the athletes blood, especially in the week after the shot, when everyones cellular reactions peaked. The athletes showed a more pronounced immune response, with presumably better protection against flu infection than the other young people, says Martina Sester, an immunologist at Saarland University and study co-author.

The researchers speculate that the athletes immune systems had been strengthened and fine-tuned by the daily physical demands and damages of training, allowing them to respond so effectively to the vaccine.

But those results, while notable, did not look at the acute effects of exercise and whether a single, intense workout might alter the bodys reactions to a vaccine, for better or worse. So, for the second of the new studies, which waspublished in July in Medicine & Science in Sports & Exercise, the scientists returned to the same data, but focused now only on the immune reactions of the athletes.

They compared the numbers of immune cells and antibodies in those athletes who happened to have gotten their flu shot within two hours of their most recent training session against those of athletes whose shot had come a day after their last workout. If intense training blunted immune reactions, then the first group of athletes would be expected to show fewer new immune cells than those who had gotten their shot after a longer rest.

But the researchers found no differences. Whether the athletes inoculations came almost immediately after training or a day later, their immune reactions were the same. A strenuous workout beforehand had not lowered or boosted the response.

Together, the two studies tell us that being in shape is likely to increase our protection from a vaccination, no matter how intensely or when we work out before the shot, Sester says.

Of course, these studies focused on elite, competitive athletes, which most of us are not. But Sester believes even more-casual recreational athletes are likely to mount better flu-vaccine responses than sedentary people. Likewise, she and her colleagues expect high fitness should improve immune responses to other vaccines, including, potentially, a COVID-19 shot.

The basic principles of vaccine response are probably the same, she says. Future studies will have to confirm that possibility, though, if and when a vaccine becomes available.

The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines

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What does ‘immunity’ to Covid-19 really mean? Here are 4 possibilities. – The Daily Briefing

August 28th, 2020 11:57 pm

Amid this week's news that a man in Hong Kong was reinfected with the novel coronavirus, STAT News Hellen Branswell asked health experts to predict how different types of immunity to the novel coronavirus, or a lack thereof, could dictate what a future with the virus would look like.

Researchers have been working to understand whether exposure to the novel coronavirus could protect people from future infection. Questions regarding immunity to the coronavirus haven't yet been answered definitively, but researchers have pointed to some preliminary evidence suggesting that people infected with the virus develop antibodies and other immune responses that could protect them against reinfection for at least several months to potentially a few years.

However, some health care providers have reported cases in which patients appeared to become reinfected with the virus. And on Monday, researchers in Hong Kong confirmed the first documented case of novel coronavirus reinfection. According to the researchers, a 33-year-old man who was first diagnosed with a novel coronavirus in March, and who had recovered from that infection, was later infected with a different strain of the virus that had been spreading throughout Europe in July and August.

That case has spurred even more questions about the type of immunity people may develop to the novel coronavirus, Branswell reports. Recently, she asked health experts to predict how different types of immunity to the virus, or a lack thereof, could dictate what a future with the virus would look like, and Vineet Menachery, a coronavirus researcher at the University of Texas Medical Branch, came up with four different scenarios that are quite "hopeful," Branswell writes. However, she cautions that the scenarios described are merely "educated guesses, based on what's known about the way the immune system works in general, and how it responds to other coronaviruses."

Sterilizing immunity

The best-case scenario, Branswell writes, would be so-called "sterilizing immunity," which can fight off a virus "before infection can take hold."

According to Branswell, this type of immunity usually occurs when the body incurs a pathogen that induces strong and durable immune responses during initial infection, such as measles. But unfortunately for the current crisis, respiratory viruses that infect the mucus membranes in the nose and throatsuch as the novel coronavirusdon't usually result in sterilizing immunity.

"Sterilizing [immunity] in my view is out of the question, as with any respiratory virus," said Marion Koopmans, head of virology at Erasmus Medical Center in the Netherlands.

Stanley Perlman, a researcher at the University of Iowa, seemingly agreed, noting it was "not so likely" the novel coronavirus will induce sterilizing immunity.

The low likelihood that infection from the coronavirus can induce sterilizing immunity has raised concerns that a vaccine against the virus wouldn't be able to generate sterilizing immunity, either, Branswell writes. It's also sparked concerns that a vaccine wouldn't prevent the virus' spreadeven though it might reduce the severity of Covid-19, the disease caused by the virus.

"[W]e'd all like immunity that protects the individualprotects from infection and protects from transmission," said Malik Peiris, a coronavirus expert at Hong Kong University, but "[w]e may not achieve that, because protecting from infection of the upper respiratory tract and then transmission is quite a challenge."

Functional immunity

However, one type of immune response that may be "within reach," according to Branswell, is "functional immunity," which occurs when a body recognizes a pathogen, either due to a previous infection or vaccination. While people who develop this type of immunity could become reinfected with the pathogen at a later date, they would experience a milder, shorter infection.immunity, immunity, people who

"It may be possible to become infected again, without any change in the virus," said Christian Drosten, director of the Institute of Virology at Berlins Charit University Hospital. But "[t]he resulting infection will be mild or asymptomatic, with significantly lower levels of virus replication and onward transmission."

So ultimately, even though there would still be cases of coronavirus infection and Covid-19, the disease "won't have the impact it has now" under this immunity scenario, Peiris said. "It becomes manageable."

And, according to the experts, the immune responses we've seen so far to the novel coronavirus are in line with what they'd expect to see under this scenarioincluding in the recent Hong Kong case. While the man in that case experienced symptoms of Covid-19 during his first infection, he reportedly didn't experience Covid-19 symptoms during the second infection.

For his part, Menachery said he thinks it's likely that most people will develop functional immunity to the novel coronavirus.

"The idea there is that, yes, your antibodies might wane, but your memory responses aren't absent," he said. "I'm a believer that if you've gotten Covid-19, then your likelihood of dying from a second Covid-19 case is very low, if you maintain immunity."

And if people who are reinfected experience a lesser infection, they might also generate lower levels of the virus, meaning they could be less likely to pass it on, Branswell reports. "It may become a rare infection, although that is difficult to foresee given the size of the global population," Koopmans said.

In addition, children, who appear less likely to develop severe cases of Covid-19 than adults, might never experience a severe case of the disease after developing functional immunity over their lifetimes. "I think that's kind of how, in the long run, it would play out without the intervention of vaccines," Krammer said. "I think with vaccines, we just basically speed up that process."

However, experts warned of one big question regarding this type of immunity: Whether and to what extent people whose first infections did not result in symptoms of Covid-19, or who had very mild cases, would develop this longer-lasting immune response. Perlman was cautiously hopeful, saying he would hypothesize that such individuals would have sufficient protection against severe cases of the disease.

Waning immunity

The third scenario involves a variant of functional immunity called "waning immunity," Branswell writes, in which people who have been infected with or vaccinated against the novel coronavirus could experience a decreased level of protection over time. According to Branswell, this type of immune response is seen with four coronaviruses that cause common colds and can reinfect people "after a relatively short period of time."

For example, one Dutch study, which has not yet been peer reviewed, measured antibody levels for those four coronaviruses in 10 people for decades and "saw frequent reinfections at 12 months postinfection and substantial reduction in antibody levels as soon as six months postinfection," the researchers wrote.

Lia van der Hoek from Amsterdam University Medical Center, a senior author of the study, said she thinks waning immunity is the most likely immune response for people infected with the novel coronavirus.

But, she added, "It is completely unknown what the symptoms will be when reinfection occurs. This could be less, or worse, or equal. We scientists cannot make a prediction on that."

For his part, Menachery said he believes that, even if immunity faded over time, the reinfections would still be less severe. "You will never get as sick as you were the first time," Menachery said.

Lost immunity

A more dire scenario, according to Branswell, would be so-called "lost immunity," in which people who have previously been infected with the coronavirus lose immunity against the virus within a certain timeframeafter which point, any reinfection could be as severe as the first.

However, Branswell writes that "[n]one of the experts felt this was a possibility."

Menachery said people who "generate a response to clear the virus" will likely "maintain that immunity long term." However, he added that, for "people with mild or asymptomatic infection, it may not be lost immunity, but rather no immunity generated."

And overall, Branswell writes, if lost immunity is unlikely, then we will probably see the threat of Covid-19 decrease over time. "Our immune systems will know how to deal with" the novel coronavirus, she writes. "It could become the fifth human coronavirus to cause common colds."

But Dan Barouch, director of the Center for Virology and Vaccine Research at Boston's Beth Israel Deaconess Medical Center, warned that it might take a long time to reach such a point. According to Barouch, the majority of the world's population has yet to be exposed to the novel coronavirusand vaccinating everyone in the world could take years.

Further, Barouch added that it's unlikely only one of these immunity scenarios would occur. He explained that immunity often depends on a person's immune system, as well as the nature of their exposure to a pathogen. "The short answer is we don't know. So, anyone who gives you a scenario is providing a hypothesis," he said (Branswell, STAT News, 8/25).

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What does 'immunity' to Covid-19 really mean? Here are 4 possibilities. - The Daily Briefing

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How does the immune response affect inflammation in COVID-19 patients? – World Economic Forum

August 28th, 2020 11:57 pm

The severity of COVID-19 can vary hugely. In some it causes no symptoms at all and in others its life threatening, with some people particularly vulnerable to its very severe impacts.

The virus disproportionately affects men and people who are older and who have conditions such as diabetes and obesity. In the UK and other western countries, ethnic minorities have also been disproportionately affected.

While many factors contribute to how severely people are affected, including access to healthcare, occupational exposure and environmental risks such as pollution, its becoming clear that for some of these at-risk groups, its the response of their immune system inflammation that explains why they get so sick.

Specifically, were seeing that the risks associated with diabetes, obesity, age and sex are all related to the immune system functioning irregularly when confronted by the virus.

Inflammation can go too far

A common feature for many patients that get severe COVID is serious lung damage caused by an overly vigorous immune response. This is characterised by the creation of lots of inflammatory products called cytokines the so-called cytokine storm.

Cytokines can be really powerful tools in the immune response: they can stop viruses reproducing, for example. However, some cytokine actions such as helping bring in other immune cells to fight an infection or enhancing the ability of these recruited cells to get across blood vessels can cause real damage if they are not controlled. This is exactly what happens in a cytokine storm.

Many white blood cells create cytokines, but specialised cells called monocytes and macrophages seem to be some of the biggest culprits in generating cytokine storms. When properly controlled, these cells are a force for good that can detect and destroy threats, clear and repair damaged tissue, and bring in other immune cells to help.

However, in severe COVID the way monocytes and macrophages work misfires. And this is particularly true in patients with diabetes and obesity.

Diabetes, if not controlled well, can result in high levels of glucose in the body. A recent study showed that, in COVID, macrophages and monocytes respond to high levels of glucose with worrying consequences.

The virus that causes COVID, SARS-CoV-2, needs a target to latch onto in order to invade our cells. Its choice is a protein on the cell surface called ACE2. Glucose increases the levels of ACE2 present on macrophages and monocytes, helping the virus infect the very cells that should be helping to kill it.

Cytokines, small proteins released by a number of immune cells, play a key role in directing the immune response.

Image: scientificanimations.com

Once the virus is safely inside these cells, it causes them to start making lots of inflammatory cytokines effectively kick-starting the cytokine storm. And the higher the levels of glucose, the more successful the virus is at replicating inside the cells essentially the glucose fuels the virus.

But the virus isnt done yet. It also causes the virally infected immune cells to make products that are very damaging to the lung, such as reactive oxygen species. And on top of this, the virus reduces the ability of other immune cells lymphocytes to kill it.

Obesity also causes high levels of glucose in the body and, similar to diabetes, affects macrophage and monocyte activation. Research has shown that macrophages from obese individuals are an ideal place for SARS-CoV-2 to thrive.

Other risks tied to inflammation

The same sort of inflammatory profile that diabetes and obesity cause is also seen in some older people (those over 60 years). This is due to a phenomenon known as inflammageing.

Inflammageing is characterised by having high levels of pro-inflammatory cytokines. Its influenced by a number of factors, including genetics, the microbiome (the bacteria, viruses and other microbes that live inside and on you) and obesity.

Many older people also have fewer lymphocytes the very cells that can specifically target and destroy viruses.

This all means that for some older people, their immune system is not only poorly equipped to fight off an infection, but it is also more likely to lead to a damaging immune response. Having fewer lymphocytes also means vaccines may not work as well, which is crucial to consider when planning a future COVID vaccine campaign.

Irregular inflammatory responses are emerging as a common theme across the different risk factors for severe COVID.

Image: EPA-EFE

Another puzzle that has been worrying researchers is why men seem so much more vulnerable to COVID. One reason is that cells in men seem to be more readily infected by SARS-CoV-2 than women. The ACE2 receptor that the virus uses to latch onto and infect cells is expressed much more highly in men than women. Men also have higher levels of an enzyme called TMPRSS2 that promotes the ability of the virus to enter the cells.

Immunology is also offering some clues on the sex difference. Its long been known that men and women differ in their immune responses, and this is true in COVID.

A recent pre-print (research that has not yet been reviewed) has tracked and compared the immune response to SARS-CoV-2 in men and women over time. It found that men were more likely to develop atypical monocytes that were profoundly pro-inflammatory and capable of making cytokines typical of a cytokine storm. Women also tended to have a more robust T cell response, which is needed for effective virus killing. However, increased age and having a higher body mass index reversed the protective immune effect in women.

Studies like these highlight how different people are. The more we understand about these differences and vulnerabilities, the more we can consider how best to treat each patient. Data like these also highlight the need to consider variation in immune function and include people of varied demographics in drug and vaccine trials.

Originally posted here:
How does the immune response affect inflammation in COVID-19 patients? - World Economic Forum

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Sterile Filtration Market To Reach USD 8.48 Billion By 2027 | CAGR: 7.7% | Reports And Data – PRNewswire

August 28th, 2020 11:56 pm

NEW YORK, Aug. 27, 2020 /PRNewswire/ --The GlobalSterile Filtration Marketis expected to reach USD 8.48 Billion by 2027, according to a new report by Reports and Data. Sterile filtration finds usage in the removal of contaminants and particulates from fluids comprising media with or without buffers, serum, reagents, biologic or proteinaceous samples, or other types of fluids. Filtration through a pore size of 0.2 m is essential to get a sterile filtrate by filtering particles and germs from fluids (liquids and gases) to prevent them from contaminating the end-products. As per the GMP guidelines and the guidelines by the (FDA), producers are required to perform a filter integrity test at the pre and post-production cycle. The test confirms that the filter is completely functional and that no undesirable components got through it.

Biopharmaceuticals products normally cannot be terminally sterilized, and thus it is crucial to use sterile grade filters in aseptic processing. Application of heat sterilization or any other process in biopharmaceutical drug products results in unwanted degradation of the product. Sterilizing membrane filtration frequently necessitated reducing the levels of bioburden within process streams to prevent the potential formation of biofilm. Further, to ascertain that the sterile filtered products uphold the pure form, a growing number of firms, especially the firms in the pharmaceutical sector, are deploying disposable process solutions to store or process the subsequent filtrate.

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The growing use of sterile filtration in the food & beverage industry, especially in breweries, is playing an instrumental role in driving market growth. Recent researches uphold the use of sterile filtration as the most appropriate method for brewers for controlling microbial hazards. Even though beer is alcoholic, acidic, anaerobic, and comprises hop compounds that ply the role of preservatives, certain microorganisms can survive in the chemical environment and thrive on rich nutrients present in beer. These kinds of microorganisms may result in beer spoilage forming a haze or sedimentation, a rancid/sour flavor, and over-carbonation, thus requiring the need for sterile filtration.

COVID-19 Impact Analysis

As global economies are experiencing the negative impact of the Covid-19 pandemic, organizations are suffering losses, among various other challenges. Nevertheless, firms in the pharmaceutical industry are of immense importance in combatting the pandemic and are witnessing positive growth in the contagious disease landscape with the race for treatment approval therapy gaining momentum.

Biopharmaceutical companies are playing a significant role in human response to the COVID-19 pandemic. Various leading biotech companies are studying the genome to prepare a feasible vaccine for its treatment. Growing investments in R&D activities for making the vaccine are fuelling the growth of the sterile filtration market.

To identify the key trends in the industry, click on the link below: https://www.reportsanddata.com/report-detail/sterile-filtration-market

Further key findings from the report suggest

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For the purpose of this report, Reports and Data has segmented the Global Sterile Filtration Market on the basis of type, membrane type, application, end-user, and region:

TypeOutlook (Revenue, USD Million; 2017-2027)

Membrane TypeOutlook (Revenue, USD Million; 2017-2027)

ApplicationOutlook (Revenue, USD Million; 2017-2027)

End-UserOutlook (Revenue, USD Million; 2017-2027)

Regional Outlook (Revenue, USD Million;2017-2027)

Have a Look at Similar Research Reports:

Laboratory Filtration Market- Filtration is a technique that is used to separate solids from liquids or solution by interposing a filter medium through which solutions or liquids can pass.

Virus Filtration Market - increasing emphasis and growing investment in R&D activities in the biotechnology sector, there has been an elevated demand for virus filtration.

Gene Expression Market - Gene expression is the method that refers to the process of measuring the activity of genes in order to comprehend the cellular functions.

In vivo CRO Market - Shifting of preference of pharmaceutical industries toward the outsourcing clinical and preclinical trials to focus on their core business, increasing frequency of outsourcing R&D activities.

Protein Engineering Market- Protein engineering is an emerging field that involves synthesis of new proteins as well as amendment in the existing protein structures that ultimately helps to achieve desired functions.

3D Cell Culture Market- The growth is mainly contributed by the government and non-government investments for cancer research & development, coupled with large scale end users for stem cell research.

About Reports and Data

Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target and analyze consumer behavior shifts across demographics, across industries and help client's make a smarter business decision. We offer market intelligence studies ensuring relevant and fact-based research across a multiple industries including Healthcare, Technology, Chemicals, Power and Energy. We consistently update our research offerings to ensure our clients are aware about the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise.

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Burger Reviews BTK Inhibitors and Beyond in Frontline CLL – Targeted Oncology

August 28th, 2020 11:56 pm

During a virtual Case Based Peer Perspectives event, Jan A. Burger, MD, PhD, professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, TX, discussed testing and the treatment options for chronic lymphocytic leukemia (CLL), based on the a case of 71-year-old female patient.

Targeted OncologyTM: What testing would you order to confirm diagnosis if you saw this patient in the clinic?

BURGER: We need to establish the diagnosis by flow cytometry and then we would do, at a minimum, FISH cytogenetics and, ideally, the mutational status. Cytogenetics can change, butmutational status usually doesnt change. If thats been established somewhere outside [of your clinic], then you dont have to repeat that test.

Its important to repeat cytogenetics if you talk about the relapse setting. But here, were treating in the frontline setting, and she was tested. She was found to be IGHV unmutated and [positivefor] del(11q). That, traditionally, has been regarded as a higher-risk disease status because these patients respond OK to standard chemotherapy, but they have short remissions and survival times with FCR [fludarabine, cyclophosphamide, and rituximab (Rituxan)], BR [bendamustine plus rituximab], and those kinds of regimens compared with low-risk patients, such as those [who are positive for] deletion 13q and have IGHV mutated disease.

In terms of these sequences, when you see a patient with lymphocytosis, you send for flow cytometry, and part of the flow cytometry panel can test for additional markers, CD38 and ZAP-70. We have it [at MD Anderson], but Im not sure if there are any outside routine flow cytometry labs reporting CD38 positivity or negativity or ZAP-70. These markers used to be very popular 10years or so ago when IGHV-mutation status was not so commonly done and was more complicated to get. Nowadays, theres a shift with sending a sample directly for IGHV-mutation testing.

If you have that and the routine CLL FISH panel, then you have a good amount of information about your patient to say this is high-, low-, or an intermediate-risk disease. I think the main purpose for doing these is, first, to identify [patients with] high-risk disease who have a deletion 17p [del(17p)] or TP53 mutations. If its a young patient, you want to know that to [be able to] avoid chemotherapy. If its a young patient, [you may want to] send those patients for evaluation for stem cell transplant. For some patients, that is still something that eventually needs to be considered for those with del(17p).

What systemic therapy would you offer?

If you have treated with ibrutinib [Imbruvica] and youre comfortable with that, I dont think at this time there is a strong reason to change. In selected patients, it might be reasonable to tryswitching them from one [agent] to the other. But right now, for this patient, consensus says a BTK [Bruton tyrosine kinase] inhibitor is a good treatment.

Both ibrutinib and acalabrutinib [Calquence] can be used as single agents or in combination with CD20 antibodies. Weve done a clinical study with ibrutinib where patients were randomized to receive monotherapy versus a combination with rituximab, and the outcome was virtually identicalwhere patients had the exact same progression-free survival [PFS] with a single agentversus the combination with a CD20 antibody.1

CD20 antibodies with BTK inhibitors dont seem to add benefit in terms of survival if you go with the long-term BTK inhibitor treatment and if youre not planning to stop your treatment atsome point. What they do is they get patients into remission faster and you clear the disease faster if you add a CD20 antibody, but then you stop after 6 months. You continue your BTKinhibitor, and patients do great 2, 3, and 4 years later. Then, you dont see any effect in terms of longer-term PFS or overall survival [OS] from the addition of the CD20 antibody.

What data support the use of single-agent ibrutinib in patients with untreated CLL?

There are data from the RESONATE-2 study [NCT01722487], which randomized patients between ibrutinib and chlorambucil. This study was designed at the time when chlorambucil monotherapy was still the standard of care. Patients were randomized 1:1, and patients with del(17p) were excluded.2

What is nice about this study is that we have a long follow-up now.3 At the 5-year follow-up, you see this major difference in terms of PFS [HR, 0.146; 95% CI, 0.098-0.218]. There is also anoverall survival benefit [HR, 0.450; 95% CI, 0.266-0.761].

What [we saw was] that patients with del(11q) seemed to have a better PFS than those patients who lack del(11q) when they are treated with ibrutinib. Patients with del(11q) who are treated with chemotherapy do not do as well as those who lack this cytogenetic abnormality. The same is true here for [IGHV] mutational status.

The PCYC-1102-CA study [NCT01105247] opened around 2010, and we now have 7 to 8 years of follow-up. If you use a BTK inhibitor in the frontline setting, you can expect that most patients are going to do well for an extended period of time. At 5, 6, and 7 years or longer, 70% to 80% of patients are still in remission and have not died.4

Another randomized study that created some waves [is the E1912 study (NCT02048813)]. Weve been big proponents of FCR, which was the comparator arm [of this trial] versus ibrutinib. Patients receive either 6 cycles FCR or continuous ibrutinib [with rituximab] for the first 6 cycles.5

That study showed that compared with FCR, there was a significant increase in PFS [HR, 0.39; 95% CI, 0.26-0.57; P <.0001] but also in OS benefit from the BTK inhibitorcontaining regimen[HR, 0.34; 95% CI, 0.15-0.79; P = .009].

Would you say ibrutinib is the standard of care for treatment of CLL in the frontline setting?

Ibrutinib monotherapy, I would say, is the standard of care, but ibrutinib plus rituximab can be used. Some of you use it and, based on the data we just saw, the FDA has now officiallyapproved it.6 It doesnt mean you must use rituximab.

What other ibrutinib combinations are available?

The ALLIANCE trial [NCT01886872] had a single-agent ibrutinib arm versus ibrutinib plus rituximab versus bendamustine plus rituximab.7 When you have patients randomized to receive ibrutinib/rituximab versus ibrutinib as a single agent, the [Kaplan-Meier survival] curves are basically identical, and thats what we got as well in a slightly diff erent patient population, mostlyrelapsed patients. In terms of PFS, rituximab doesnt seem to add very much when you go with continuous ibrutinib treatment. You see the difference for bendamustine/rituximab, with whichpatients have significantly shorter PFS.

I think the theme is the same over and over again with these randomized studies. With the new targeted agents, such as the BTK inhibitors and venetoclax [Venclexta], we see the samepattern. The new agents are doing better than our traditional chemoimmunotherapy.

ILLUMINATE [NCT02264574] is the study comparing ibrutinib/obinutuzumab [Gazyva] with another chemoimmunotherapy regimen, which has been somewhat popular for older populations, more frail patients for whom you dont want to use FCR or BR. You traditionally use chlorambucil alone and then more recentlyits combined with CD20 antibodies. The patients were randomized to either [ibrutinib/obinutuzumab] versus chlorambucil/obinutuzumab treatment.8

The results show a major PFS benefits for patients on the BTK inhibitor [HR, 0.23; 95% CI, 0.15-0.37; P < .0001]. There was a big difference for genetically high-risk patients [HR, 0.15; P <.0001] or patients who had bulky disease.

What other BTK inhibitors would you consider here?

Now were going to the second-generation BTK inhibitor, acalabrutinib [Calquence], which is somewhat more selective and doesnt inhibit some other kinases that ibrutinib does. Its a newBTK inhibitor with not as much long-term follow-up data available.

[In the phase 3 ELEVATE TN trial (NCT02475681)], you have 3 arms: single-agent acalabrutinib, acalabrutinib combined with obinutuzumab, and the comparator arm of chlorambucil/obinutuzumab. 9 If you give that to treatment-nave patients, those receiving BTK inhibitor alone or with the CD20 antibody do well. Its debatable if the PFS difference is significant, but clearly, the BTK inhibitortreated patients do much better than those receivingchlorambucil plus obinutuzumab.

[If you look at the] subgroups of patients benefitting from the BTK inhibitor treatment versus obinutuzumab/chlorambucil, it basically shows that all subgroups have benefit. Some may be alittle more than others...but I think particularly patients that we traditionally called high risk are the ones who benefit the most from new agents. Theres less difference if you go into the lowriskpatient populations.

Are there data supporting the use of a BCL2 inhibition?

The other frontline option involves venetoclax, and thats coming from this CLL14 trial [NCT02242942]. Patients were receiving venetoclax/obinutuzumab or chlorambucil/obinutuzumab, and this is a finite treatment for 12 months. These are patients who were older and who have some comorbidities. Deletion(17p) was not excluded.10

There is a major difference in PFS favoring the new targeted agent venetoclax. Now its approved for the frontline treatment of selected patients,11 but you can also see in comparison to theBTK inhibitors [that] the follow-up is relatively short of 3 years.

With venetoclax, you get more complete remissions and some of these remissions are MRD [minimal residual disease] negative. As long as these differences are not translating into a survival benefit, those are just numbers.

Would you recommend venetoclax after the first line?

I dont think theres a reason to make that change [from BTK inhibitors] because venetoclax has its own issues in terms of how its used and adverse effects [AEs]. For that questionmaybe [we ask [is] venetoclax better in terms of outcome than a BTK inhibitor?

Its difficult to be better than the BTK inhibitor in the frontline CLL setting, and you need a very long follow-up to show any differences if there are any.

A substantial number of patients [treated with venetoclax] receive MRD-negative remissions with this combination. MRD negativity doesnt mean patients are cured. There is drop off in PFS, so MRD negativity doesnt mean those patients will survive and never need treatment again. Most likely, those patients eventually will lose MRD and eventually have disease progression and need treatment again. I think for those studies based on frontline venetoclax for 12 months, we just have to stay tuned and wait for what the long-term outcome is going to be.

What are the AEs of venetoclax?

You see more AEs that are reminiscent of chemotherapy days, where patients get more cytopenia. Its well established that venetoclax is myelosuppressive. Certainly, neutropenia can be seen, and less frequently, thrombocytopenia and anemia. If you treat a patient with venetoclax with or without a CD20 antibody, then you have to prepare for some patients having issueswith neutropenia and some who cannot be fully dose-escalated because of those cytopenias.

If the patient was younger, would you treat differently?

My answer would be no. I dont see any difference. This patient was 71 years old. We wouldnt use chemoimmunotherapy.

Somebody voted no. I think thats interesting because its something Im interested in [finding out about]. Im wondering if we have to accept treating patients with BTK inhibitorsfor very long periods or if we can maybe try it at least as an alternative treatment just for a certain period of time until we have the best response. Then, some patients maybe stop. I think thats interesting for a clinical trial.

Outside of clinical trials, Im not so sure. We have no data. But if you have a low-risk patient and you want to stop after 2 years and just see what happens, you need to tell the patient we dontknow whats going to happen and you have to watch that patient more closely. If its a patient with del(17p), a high-risk patient who was very symptomatic, I wouldnt do that. But in low-risk patients, I think its an interesting question and not totally unreasonable.

Over time, we will find new solutions. Everybodys working on transitioning BTK inhibitorsto limited-duration treatments for many reasons. Its not the optimal situation to have patients onkinase inhibitors for 5, 10, or 20 years. Right now, its a long-term treatment until we have better treatments.

References:

1. Burger JA, Sivina M, Jain N, et al. Randomized trial of ibrutinib vs ibrutinib plus rituximab in patients with chronic lymphocytic leukemia. Blood. 2019;133(10):1011-1019. doi:10.1182/blood-2018-10-879429

2. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425-2437. doi:10.1056/NEJMoa1509388

3. Burger JA, Barr PM, Robak T, et al. Long-term effi cacy and safety of fi rst-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study. Leukemia. 2020;34(3):787-798. doi:10.1038/s41375-019-0602-x

4. Byrd JC, Furman RR, Coutre SE, et al. Ibrutinib treatment for fi rst-line and relapsed/ refractory chronic lymphocytic leukemia: fi nal analysis of the pivotal phase Ib/II PCYC- 1102 study. Clin Cancer Res. Published online March 24, 2020. doi:10.1158/1078-0432.CCR-19-2856

5. Shanafelt TD, Wang XV, Kay NE, et al. Ibrutinib and rituximab provides superior clinical outcome compared to FCR in younger patients with chronic lymphocytic leukemia (CLL): extended follow-up from the E1912 Trial. Blood. 2019;134(suppl 1):33. doi:10.1182/blood-2019-126824

6. FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia. News release. FDA. April 21, 2020. Accessed July 27, 2020. https://bit.ly/3jV1hGW

7. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med. 2018;379(26):2517-2528. doi:10.1056/NEJMoa1812836

8. Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in fi rst-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(1):43-56. Published correction appears in Lancet Oncol. 2019;20(1):e10.doi:10.1016/S1470-2045(18)30788-5

9. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278-1291. Published correction appears in Lancet. 2020;395(10238):1694. doi:10.1016/S0140-6736(20)30262-2

10. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. doi:10.1056/NEJMoa1815281

11. FDA approves venetoclax for CLL and SLL. News release. FDA. May 15, 2019.Accessed July 27, 2020. https://bit.ly/3jLnEOU

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CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms – GlobeNewswire

August 28th, 2020 11:56 pm

Interim analysis to commence after 28 days; results anticipated by mid-October

VANCOUVER, Washington, Aug. 25, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company has reached the requisite number of enrolled patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms to perform an interim analysis following the 28-day phase of the trial.

This Phase 3 trial is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab in patients with severe-to-critical symptoms of respiratory illness caused by COVID-19. Patients are randomized to receive weekly doses of 700 mg leronlimab or placebo, administered via weekly subcutaneous injection for two weeks. The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Recently, the Data Safety Monitoring Committee (DSMC) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study. The DSMC reviewed safety data from 149 of the 169 patients enrolled at the time of their review. The DSMC did not raise any concerns regarding safety and recommended the trial continue as planned.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very thankful for the many clinicians and their staff who have worked tirelessly to advance enrollment this quickly and for their care of these seriously ill patients. We are eager to perform an interim analysis of the data and remain optimistic the interim results will be consistent with those experienced by patients who received leronlimab through multiple EINDs (over 60) previously authorized by the FDA. And, in the event we are successful, we are well positioned with our distribution partner to accelerate distribution of leronlimab to patients throughout the U.S.

About Coronavirus Disease 2019CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA has agreed to provide written responses to the Companys questions concerning its recent Biologics License Application by September 4, 2020, in lieu of a Type A teleconference meeting for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

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