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Stem Cell Therapy Market to Discern Steadfast Expansion During 2025 – Cole of Duty

By daniellenierenberg

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem-Cell Therapy For Cardiac Disease Creative …

By daniellenierenberg

Ischemic heart disease (characterized by decreased blood supply to the heart muscle) is one of the leading causes of death worldwide.It manifests as a coronary artery occlusion, which in turn leads to myocardial infarction, accompanied by death of myocardial cells.This overloads the surviving heart muscle and eventually leads to heart failure.In addition, other causes can also cause heart failure, including chronic hypertension, which is also characterized by the gradual loss of cardiomyocytes, and experimental inhibition of programmed cell death can improve heart function.Clinically, the effective treatment to solve the fundamental problem of heart loss is heart transplantation.The new discovery that stem cells and progenitor cells have regenerative potential to treat and prevent heart failure has changed experimental research and caused explosive growth in clinical research.

Heart RegenerationAlthough heart cells have a slight ability to regenerate.However, it is generally believed that the regenerative capacity of the human heart muscle is seriously insufficient, and it is not enough to make up for the severe loss of myocardium caused by catastrophic myocardial infarction or other heart disease.Studies have found that the heart of some vertebrates (such as zebrafish and salamanders) does undergo a regenerative reaction after injury;under normal conditions, mouse and human cardiomyocytes rarely divide.But after a serious injury, the remaining cardiomyocytes will start DNA synthesis and re-enter the cell cycle.Therefore, the division of existing cardiomyocytes seems to be the most important factor for heart regeneration in mice and humans.The dedifferentiation of cardiomyocytes near the damaged area occurs before their proliferation and is characterized by the loss of expression of myocardial contractile proteins (such as -myosin heavy chain and troponin T). Studies find zebrafish heart regeneration may be mainly caused by undifferentiated stem cells or progenitor cells from the outer layer of the heart (epithelium).Further research on salamanders and zebrafish will more clearly define whether cardiac regeneration in these organisms requires dedifferentiation, proliferation and subsequent cardiomyocyte differentiation, or whether regeneration is driven by the recruitment of stem cells to the injured site.In contrast, in mammalian hearts, cardiomyocytes rarely divide after a myocardial infarction, although transgene overexpression of specific genes in mice increases the division of cardiomyocytes.

There is strong evidence that endothelial cells are renewed by bone marrow-derived progenitor cells, but the idea that cardiomyocytes are renewed by such cells has been heatedly debated. Less controversial is that adult mammalian heart muscle has a resident cardiac stem cell (CSC) population, which has the potential to differentiate into cardiomyocytes and other cell types (such as endothelial and vascular smooth muscle cells). The study found that CSCs can support the basic turnover of cardiomyocytes, but this turnover occurs at a very low rate without damage. CSCs have high proliferation and differentiation potential in vitro, and it may be a promising therapeutic direction to expand autologous CSCs in vitro or stimulate the regeneration of these cells in vivo.

The recognition that there is indeed a regeneration mechanism in the mammalian myocardium has aroused intense attention. Researchers have discovered that it may hinder the existence of aplastic disorders, including ischemia, inflammation and fibrosis at various stages of myocardial infarction. This unfavorable microenvironment may prevent the activation of resident CSCs, thereby reducing the success rate of exogenous cell therapy. Certain components of the inflammatory response may be essential to promote angiogenesis and progenitor cell recruitment, but excessive inflammation may also prevent the recruitment and survival of progenitor cells. Similarly, after myocardial infarction, a certain degree of fibrosis is required to prevent myocardial rupture, but dense fibrosis presents a strong physical barrier to regenerative cells.

Which Stem Cells Are Used In Heart Therapy?Perhaps the most confusing aspect of current cardiac regeneration is the different cell types, which are considered to be candidates for cardiac therapy.Multiple cell candidates reflect that human research on cell regeneration is not deep enough, so further research and exploration are needed.

Figure 1. Many cell types and mechanisms have been proposed for cardiac therapy.

Skeletal MyoblastOne of the earliest cell-based cardiac regeneration strategies was to inject autologous skeletal muscle myoblasts into ischemic myocardium.Myoblasts are resistant to ischemia, and can be differentiated into myotubes (but not into cardiomyocytes) in the laboratory animal experiments and improve ventricular function.The myocardial tube will not integrate with the surviving cardiomyocytes, so it will not beat synchronously with the surrounding myocardium.However, related clinical trials were terminated due to lack of efficacy, so it is unlikely that skeletal myoblasts will actually regenerate the heart muscle.Interestingly, studies found that mouse skeletal muscle contains a large number of non-satellite cells, which can differentiate into spontaneous pulsatile cells with cardiomyocyte characteristics, but no one has found similar cells in human skeletal muscle.

Bone Marrow-Derived Cells

In stem cell cardiac therapy, it was first reported that adult stem cells or progenitor cells transplanted into the infarcted heart of mice that can differentiate into cardiac myocytes are a subset of hematopoietic cells derived from bone marrow. The first evidence that adult bone marrow-derived progenitor cells are involved in the formation of cardiomyocytes in the adult human heart is based on reports of Y chromosome-positive cardiomyocytes in male recipients of transplanted female donor hearts. Animal studies using labeled hematopoietic stem cells for bone marrow transplantation and subsequent myocardial infarction have shown that cardiomyocytes are derived from transplanted cells, but the proportion is extremely low. Moreover, other studies in animals have not demonstrated that hematopoietic progenitor cells can differentiate into cardiomyocytes or improve heart function. Therefore, there is currently no consensus on whether bone marrow-derived progenitor cells differentiate into cardiomyocytes in vivo.

Embryonic stem cell

Embryonic stem (ES) cells are prototype stem cells.They clearly meet all the requirements of stem cells: cloning, self-renewal and multi-potency.ES cells can differentiate into any type of cells present in an adult organism, so it has the potential to completely regenerate the heart muscle.The two obstacles facing the clinical application of ES therapy are immune rejection and the tendency of injecting ES cells to form teratomas.With the increase in knowledge of ES cell differentiation and cardiac embryonic development pathways, ES cell differentiation may become more controllable.Methods to limit teratoma formation include genetic selection of differentiated ES cells, or differentiation of ES cells into cardiomyocytes or endothelial cells in vitro before injection.For example, tumor necrosis factor promotes the differentiation of ES cells into cardiomyocytes.If the differentiated ES cells are delivered to the myocardium in a rich survival mixture, they can survive and improve myocardial function.The inherent difficulty in controlling the growth and differentiation of ES cells and other pluripotent stem cells is that the timing of activating specific signaling pathways may be crucial.For example, recent studies on mouse and zebrafish embryos have shown that the role of the Wnt--catenin pathway in heart development depends on the stage of development.

Endogenous cardiac stem cells

Because allogeneic cells face immunological challenges that may require immune rejection, the isolation of endogenous adult mammalian CSCs based on cell surface markers has attracted great interest. However, no clear CSC mark has been determined so far. Mammalian heart muscle includes a small percentage of stem cells expressing cell surface markers Kitor Scal. In addition, some side population cells also express Kit and / or Sca1, and like Kit +CSC and Sca1 +CSC, side population cells can produce cardiomyocytes in vitro and in vivo. In addition to Kit +CSC, Sca1+CSC and side population cells, the fourth type of CSC also expresses the transcription factor Isl1. The tracer experiments showed that during embryonic heart development, cells expressing Isl1can differentiate into endothelial cells, endocardial cells, smooth muscle cells, conduction system cells, right ventricular myogenic cells and atrial myogenic cells. There are also cells that express Isl1 in the heart of adult mammals, but they are limited to the right atrium, are found in fewer numbers than the embryonic heart, and have unknown physiological effects. Recently, epicardial-derived progenitor cells with angiogenic potential have been described.

Stem cell therapy for heart disease faces some challenges.The most important question to be answered in preclinical research is which stem or progenitor cells are the best choice for treatment.So far, under certain circumstances (acute myocardial infarction), bone marrow-derived progenitor cell therapy has proven to be safe and beneficial, but the regeneration potential of this cell is still controversial.CSC may have the potential to target patients, but isolation and cultivation procedures are still in the early stages of development.ES cells have the greatest differentiation potential, but face moral barriers and the greatest risk of teratoma formation.Whether ES cell derivatives will be rejected by the hosts immune response is still under debate.However, in principle, rejection can be avoided by using cells from a pool of only 150 donors with different HLA types.If new technologies for reprogramming human and mouse fibroblasts into ES-like cells can be used, the use of patient-reprogrammed cells can reduce or even eliminate immune rejection.When designing a more rational cell-based treatment for heart disease, a key issue is to understand the mechanism by which each stem or progenitor cell type can affect myocardial function.Similarly, different cardiology, such as acute myocardial infarction and chronic ischemic cardiomyopathy, may require different types of stem or progenitor cells.

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A rampage through the body – Science Magazine

By daniellenierenberg

The lungs are ground zero, but COVID-19 also tears through organ systems from brain to blood vessels.

Science's COVID-19 coverage is supported by the Pulitzer Center.

The coronavirus wreaked extensive damage (yellow) on the lungs of a 59-year-old man who died at George Washington University Hospital, as seen in a 3D model based on computed tomography scans.

On rounds in a 20-bed intensive care unit one recent day, physician Joshua Denson assessed two patients with seizures, many with respiratory failure, and others whose kidneys were on a dangerous downhill slide. Days earlier, his rounds had been interrupted as his team tried, and failed, to resuscitate a young woman whose heart had stopped. All of the patients shared one thing, says Denson, a pulmonary and critical care physician at the Tulane University School of Medicine. They are all COVID positive.

As the number of confirmed cases of COVID-19 approaches 2.5 million globally and deaths surpass 166,000, clinicians and pathologists are struggling to understand the damage wrought by the coronavirus as it tears through the body. They are realizing that although the lungs are ground zero, the virus' reach can extend to many organs including the heart and blood vessels, kidneys, gut, and brain.

[The disease] can attack almost anything in the body with devastating consequences, says cardiologist Harlan Krumholz of Yale University and Yale-New Haven Hospital, who is leading multiple efforts to gather clinical data on COVID-19. Its ferocity is breathtaking and humbling.

Understanding the rampage could help doctors on the front lines treat the roughly 5% of infected people who become desperately and sometimes mysteriously ill. Does a dangerous, newly observed tendency to blood clotting transform some mild cases into life-threatening emergencies? Is an overzealous immune response behind the worst cases, suggesting treatment with immune-suppressing drugs could help? And what explains the startlingly low blood oxygen that some physicians are reporting in patients who nonetheless are not gasping for breath? Taking a systems approach may be beneficial as we start thinking about therapies, says Nilam Mangalmurti, a pulmonary intensivist at the Hospital of the University of Pennsylvania (HUP).

What follows is a snapshot of the fast-evolving understanding of how the virus attacks cells around the body. Despite the more than 1500 papers now spilling into journals and onto preprint servers every week, a clear picture is elusive, as the virus acts like no pathogen humanity has ever seen. Without larger, controlled studies that are only now being launched, scientists must pull information from small studies and case reports, often published at warp speed and not yet peer reviewed. We need to keep a very open mind as this phenomenon goes forward, says Nancy Reau, a liver transplant physician who has been treating COVID-19 patients at Rush University Medical Center. We are still learning.

WHEN AN INFECTED PERSON expels virus-laden droplets and someone else inhales them, the novel coronavirus, called SARS-CoV-2, enters the nose and throat. It finds a welcome home in the lining of the nose, according to a recent arXiv preprint, because cells there are rich in a cell-surface receptor called angiotensin-converting enzyme 2 (ACE2). Throughout the body, the presence of ACE2, which normally helps regulate blood pressure, marks tissues potentially vulnerable to infection, because the virus requires that receptor to enter a cell. Once inside, the virus hijacks the cell's machinery, making myriad copies of itself and invading new cells.

As the virus multiplies, an infected person may shed copious amounts of it, especially during the first week or so. Symptoms may be absent at this point. Or the virus' new victim may develop a fever, dry cough, sore throat, loss of smell and taste, or head and body aches.

If the immune system doesn't beat back SARS-CoV-2 during this initial phase, the virus then marches down the windpipe to attack the lungs, where it can turn deadly. The thinner, distant branches of the lung's respiratory tree end in tiny air sacs called alveoli, each lined by a single layer of cells that are also rich in ACE2 receptors.

Normally, oxygen crosses the alveoli into the capillaries, tiny blood vessels that lie beside the air sacs; the oxygen is then carried to the rest of the body. But as the immune system wars with the invader, the battle itself disrupts healthy oxygen transfer. Frontline white blood cells release inflammatory molecules called chemokines, which in turn summon more immune cells that target and kill virus-infected cells, leaving a stew of fluid and dead cellspusbehind (see graphic, below). This is the underlying pathology of pneumonia, with its corresponding symptoms: coughing; fever; and rapid, shallow respiration. Some COVID-19 patients recover, sometimes with no more support than oxygen breathed in through nasal prongs.

But others deteriorate, often suddenly, developing a condition called acute respiratory distress syndrome. Oxygen levels in their blood plummet, and they struggle ever harder to breathe. On x-rays and computed tomography scans, their lungs are riddled with white opacities where black spaceairshould be. Commonly, these patients end up on ventilators. Many die, and survivors may face long-term complications (see sidebar, p. 359). Autopsies show their alveoli became stuffed with fluid, white blood cells, mucus, and the detritus of destroyed lung cells.

Some clinicians suspect the driving force in many gravely ill patients' downhill trajectories is a disastrous overreaction of the immune system known as a cytokine storm, which other viral infections are known to trigger. Cytokines are chemical signaling molecules that guide a healthy immune response; but in a cytokine storm, levels of certain cytokines soar far beyond what's needed, and immune cells start to attack healthy tissues. Blood vessels leak, blood pressure drops, clots form, and catastrophic organ failure can ensue.

Some studies have shown elevated levels of these inflammation-inducing cytokines in the blood of hospitalized COVID-19 patients. The real morbidity and mortality of this disease is probably driven by this out of proportion inflammatory response to the virus, says Jamie Garfield, a pulmonologist who cares for COVID-19 patients at Temple University Hospital.

But others aren't convinced. There seems to have been a quick move to associate COVID-19 with these hyperinflammatory states. I haven't really seen convincing data that that is the case, says Joseph Levitt, a pulmonary critical care physician at the Stanford University School of Medicine.

He's also worried that efforts to dampen a cytokine response could backfire. Several drugs targeting specific cytokines are in clinical trials in COVID-19 patients. But Levitt fears those drugs may suppress the immune response that the body needs to fight off the virus. There's a real risk that we allow more viral replication, Levitt says.

Meanwhile, other scientists are zeroing in on an entirely different organ system that they say is driving some patients' rapid deterioration: the heart and blood vessels.

IN BRESCIA, ITALY, a 53-year-old woman walked into the emergency room of her local hospital with all the classic symptoms of a heart attack, including telltale signs in her electrocardiogram and high levels of a blood marker suggesting damaged cardiac muscles. Further tests showed cardiac swelling and scarring, and a left ventriclenormally the powerhouse chamber of the heartso weak that it could only pump one-third its normal amount of blood. But when doctors injected dye in her coronary arteries, looking for the blockage that signifies a heart attack, they found none. Another test revealed the real cause: COVID-19.

How the virus attacks the heart and blood vessels is a mystery, but dozens of preprints and papers attest that such damage is common. A 25 March paper in JAMA Cardiology found heart damage in nearly 20% of patients out of 416 hospitalized for COVID-19 in Wuhan, China. In another Wuhan study, 44% of 36 patients admitted to the intensive care unit (ICU) had arrhythmias.

The disruption seems to extend to the blood itself. Among 184 COVID-19 patients in a Dutch ICU, 38% had blood that clotted abnormally, and almost one-third already had clots, according to a 10 April paper in Thrombosis Research. Blood clots can break apart and land in the lungs, blocking vital arteriesa condition known as pulmonary embolism, which has reportedly killed COVID-19 patients. Clots from arteries can also lodge in the brain, causing stroke. Many patients have dramatically high levels of D-dimer, a byproduct of blood clots, says Behnood Bikdeli, a cardiovascular medicine fellow at Columbia University Medical Center.

The more we look, the more likely it becomes that blood clots are a major player in the disease severity and mortality from COVID-19, Bikdeli says.

Infection may also lead to blood vessel constriction. Reports are emerging of ischemia in the fingers and toesa reduction in blood flow that can lead to swollen, painful digits and tissue death.

In the lungs, blood vessel constriction might help explain anecdotal reports of a perplexing phenomenon seen in pneumonia caused by COVID-19: Some patients have extremely low blood-oxygen levels and yet are not gasping for breath. In this scenario, oxygen uptake is impeded by constricted blood vessels rather than by clogged alveoli. One theory is that the virus affects the vascular biology and that's why we see these really low oxygen levels, Levitt says.

If COVID-19 targets blood vessels, that could also help explain why patients with pre-existing damage to those vessels, for example from diabetes and high blood pressure, face higher risk of serious disease. Recent Centers for Disease Control and Prevention (CDC) data on hospitalized patients in 14 U.S. states found that about one-third had chronic lung diseasebut nearly as many had diabetes, and fully half had pre-existing high blood pressure.

Mangalmurti says she has been shocked by the fact that we don't have a huge number of asthmatics or patients with other respiratory diseases in her hospital's ICU. It's very striking to us that risk factors seem to be vascular: diabetes, obesity, age, hypertension.

Scientists are struggling to understand exactly what causes the cardiovascular damage. The virus may directly attack the lining of the heart and blood vessels, which, like the nose and alveoli, are rich in ACE2 receptors. By altering the delicate balance of hormones that help regulate blood pressure, the virus might constrict blood vessels going to the lungs. Another possibility is that lack of oxygen, due to the chaos in the lungs, damages blood vessels. Or a cytokine storm could ravage the heart as it does other organs.

We're still at the beginning, Krumholz says. We really don't understand who is vulnerable, why some people are affected so severely, why it comes on so rapidly and why it is so hard [for some] to recover.

THE WORLDWIDE FEARS of ventilator shortages for failing lungs have received plenty of attention. Not so a scramble for another type of equipment: kidney dialysis machines. If these folks are not dying of lung failure, they're dying of renal failure, says neurologist Jennifer Frontera of New York University's Langone Medical Center, which has treated thousands of COVID-19 patients. Her hospital is developing a dialysis protocol with a different kind of machine to support more patients. What she and her colleagues are seeing suggests the virus may target the kidneys, which are abundantly endowed with ACE2 receptors.

According to one preprint, 27% of 85 hospitalized patients in Wuhan had kidney failure. Another preprint reported that 59% of nearly 200 hospitalized COVID-19 patients in China's Hubei and Sichuan provinces had protein in their urine, and 44% had blood; both suggest kidney damage. Those with acute kidney injury were more than five times as likely to die as COVID-19 patients without it, that preprint reported.

The lung is the primary battle zone. But a fraction of the virus possibly attacks the kidney. And as on the real battlefield, if two places are being attacked at the same time, each place gets worse, says co-author Hongbo Jia, a neuroscientist at the Chinese Academy of Sciences's Suzhou Institute of Biomedical Engineering and Technology.

One study identified viral particles in electron micrographs of kidneys from autopsies, suggesting a direct viral attack. But kidney injury may also be collateral damage. Ventilators boost the risk of kidney damage, as do antiviral compounds including remdesivir, which is being deployed experimentally in COVID-19 patients. Cytokine storms can also dramatically reduce blood flow to the kidney, causing often-fatal damage. And pre-existing diseases like diabetes can increase the chances of kidney injury. There is a whole bucket of people who already have some chronic kidney disease who are at higher risk for acute kidney injury, says Suzanne Watnick, chief medical officer at Northwest Kidney Centers.

ANOTHER STRIKING SET of symptoms in COVID-19 patients centers on the brain and nervous system. Frontera says 5% to 10% of coronavirus patients at her hospital have neurological symptoms. But she says that is probably a gross underestimate of the number whose brains are struggling, especially because many are sedated and on ventilators.

Frontera has seen patients with the brain inflammation encephalitis, seizures, and a sympathetic storm, a hyperreaction of the sympathetic nervous system that causes seizurelike symptoms and is most common after a traumatic brain injury. Some people with COVID-19 briefly lose consciousness. Others have strokes. Many report losing their sense of smell and taste. And Frontera and others wonder whether, in some cases, infection depresses the brain stem reflex that senses oxygen starvationanother explanation for anecdotal observations that some patients aren't gasping for air, despite dangerously low blood oxygen levels.

ACE2 receptors are present in the neural cortex and brain stem, says Robert Stevens, an intensive care physician at Johns Hopkins Medicine. And the coronavirus behind the 2003 severe acute respiratory syndrome (SARS) epidemica close cousin of today's culpritwas able to infiltrate neurons and sometimes caused encephalitis. On 3 April, a case study in the International Journal of Infectious Diseases, from a team in Japan, reported traces of new coronavirus in the cerebrospinal fluid of a COVID-19 patient who developed meningitis and encephalitis, suggesting it, too, can penetrate the central nervous system.

But other factors could be damaging the brain. For example, a cytokine storm could cause brain swelling. The blood's exaggerated tendency to clot could trigger strokes. The challenge now is to shift from conjecture to confidence, at a time when staff are focused on saving lives, and even neurologic assessments like inducing the gag reflex or transporting patients for brain scans risk spreading the virus.

Last month, Sherry Chou, a neurologist at the University of Pittsburgh Medical Center, began to organize a worldwide consortium that now includes 50 centers to draw neurological data from care patients already receive. Early goals are simple: Identify the prevalence of neurologic complications in hospitalized patients and document how they fare. Longer term, Chou and her colleagues hope to gather scans and data from lab tests to better understand the virus' impact on the nervous system, including the brain.

No one knows when or how the virus might penetrate the brain. But Chou speculates about a possible invasion route: through the nose, then upward and through the olfactory bulbexplaining reports of a loss of smellwhich connects to the brain. It's a nice sounding theory, she says. We really have to go and prove that.

A 58-year-old woman with COVID-19 developed encephalitis, with tissue damage in the brain (arrows).

Most neurological symptoms are reported from colleague to colleague by word of mouth, Chou adds. I don't think anybody, and certainly not me, can say we're experts.

IN EARLY MARCH, a 71-year-old Michigan woman returned from a Nile River cruise with bloody diarrhea, vomiting, and abdominal pain. Initially doctors suspected she had a common stomach bug, such as Salmonella. But after she developed a cough, doctors took a nasal swab and found her positive for the novel coronavirus. A stool sample positive for viral RNA, as well as signs of colon injury seen in an endoscopy, pointed to a gastrointestinal (GI) infection with the coronavirus, according to a paper posted online in The American Journal of Gastroenterology (AJG).

Her case adds to a growing body of evidence suggesting the new coronavirus, like its cousin SARS, can infect the lining of the lower digestive tract, where ACE2 receptors are abundant. Viral RNA has been found in as many as 53% of sampled patients' stool samples. And in a paper in press at Gastroenterology, a Chinese team reported finding the virus' protein shell in gastric, duodenal, and rectal cells in biopsies from a COVID-19 patient. I think it probably does replicate in the gastrointestinal tract, says Mary Estes, a virologist at Baylor College of Medicine.

Recent reports suggest up to half of patients, averaging about 20% across studies, experience diarrhea, says Brennan Spiegel of Cedars-Sinai Medical Center in Los Angeles, coeditor-in-chief of AJG. GI symptoms aren't on CDC's list of COVID-19 symptoms, which could cause some COVID-19 cases to go undetected, Spiegel and others say. If you mainly have fever and diarrhea, you won't be tested for COVID, says Douglas Corley of Kaiser Permanente, Northern California, co-editor of Gastroenterology.

The presence of virus in the GI tract raises the unsettling possibility that it could be passed on through feces. But it's not yet clear whether stool contains intact, infectious virus, or only RNA and proteins. To date, We have no evidence that fecal transmission is important, says coronavirus expert Stanley Perlman of the University of Iowa. CDC says that, based on experiences with SARS and with the coronavirus that causes Middle East respiratory syndrome, the risk from fecal transmission is probably low.

The intestines are not the end of the disease's march through the body. For example, up to one-third of hospitalized patients develop conjunctivitispink, watery eyesalthough it's not clear that the virus directly invades the eye.

Other reports suggest liver damage: More than half of COVID-19 patients hospitalized in two Chinese centers had elevated levels of enzymes indicating injury to the liver or bile ducts. But several experts told Science that direct viral invasion isn't likely the culprit. They say other events in a failing body, like drugs or an immune system in overdrive, are more likely causes of the liver damage.

This map of the devastation that COVID-19 can inflict on the body is still just a sketch. It will take years of painstaking research to sharpen the picture of its reach, and the cascade of effects in the body's complex and interconnected systems that it might set in motion. As science races ahead, from probing tissues under microscopes to testing drugs on patients, the hope is for treatments more wily than the virus that has stopped the world in its tracks.

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Study on Autologous Stem Cell Based Therapies Market (impact of COVID-19) 2020-2026 Brainstorm Cell Therapeutics, Tigenix, Med cell Europe – Bandera…

By daniellenierenberg

Detailed market survey on the Global Autologous Stem Cell Based Therapies Market Research Report 2020-2026. It analyses the vital factors of the Autologous Stem Cell Based Therapies market supported present business Strategy, Autologous Stem Cell Based Therapies market demands, business methods utilised by Autologous Stem Cell Based Therapies market players and therefore the future prospects from numerous angles well. Business associatealysis could be a market assessment tool utilized by business and analysts to grasp the quality of an business. Autologous Stem Cell Based Therapies Market report It helps them get a sense of what is happening in an industry, i.e., demand-supply statistics, Autologous Stem Cell Based Therapies Market degree of competition within the industry, Autologous Stem Cell Based Therapies Market competition of the business with different rising industries, future prospects of the business.

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The Global Autologous Stem Cell Based Therapies Market report is a fully analyzed and intelligent study of the international industry that focuses on a wide range of significant elements such as market size in terms of value and volume, regional growth analysis, competition and segmentation. It is considered as extraordinary findings that accountable to offer insightful details into some essential attributes related to the global Autologous Stem Cell Based Therapies Market 2020. The detailed investigation of this report has been carried out by the list of skillful researchers and investigators with a deep analysis of current industry trends, availability of distinct opportunities, drivers, openings and limitation that influence the Autologous Stem Cell Based Therapies Market on the global scale.

The Global Autologous Stem Cell Based Therapies market worth about xx billion USD in 2020 and it is expected to reach xx billion USD in 2026 with an average growth rate of x%. United States is the largest production of Autologous Stem Cell Based Therapies Market and consumption region in the world, Europe also play important roles in global Autologous Stem Cell Based Therapies market while China is fastest growing region.

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Geographically, Autologous Stem Cell Based Therapies market report is segmented into several key Regions, with production, consumption, revenue. The major regions involved in Autologous Stem Cell Based Therapies Market are (United States, EU, China, and Japan).

Leading companies reviewed in the Autologous Stem Cell Based Therapies report are:

RegeneusMesoblastPluristem Therapeutics IncU.S. STEM CELL, INC.Brainstorm Cell TherapeuticsTigenixMed cell Europe

Autologous Stem Cell Based Therapies Market Product Type Segmentation As Provided Below:The Autologous Stem Cell Based Therapies Market report is segmented into following categories:

The product segment of the report offers product market information such as demand, supply and market value of the product.

The application of product in terms of USD value is represented in numerical and graphical format for all the major regional markets.The Autologous Stem Cell Based Therapies market report is segmented into Type by following categories;Embryonic Stem CellResident Cardiac Stem CellsUmbilical Cord Blood Stem Cells

The Autologous Stem Cell Based Therapies market report is segmented into Application by following categories;Neurodegenerative DisordersAutoimmune DiseasesCardiovascular Diseases

Reportedly, the massive growth graph in the research and development sectors will be liable to generate plenty of excellent opportunities in the upcoming years. The Autologous Stem Cell Based Therapies market is a valuable resource of insightful information for specific business strategists. Apart from this, it also offers an in-depth summary of the Autologous Stem Cell Based Therapies Market along with growth assessment, revenue share, demand & supply data, historical as well as futuristic amount etc. A group of research analysts offers a detailed description of the value chain and its distributors info. Moreover, the Autologous Stem Cell Based Therapies market study report delivers comprehensive information regarding the global industry that enhances the scope, understanding and application of the same.

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Industry analysis, for an entrepreneur or a company, is a method that helps it to understand its position relative to other participants in the Autologous Stem Cell Based Therapies Market. It helps them to identify both the opportunities and threats coming their way and gives them a strong idea of the present and future scenario of the Autologous Stem Cell Based Therapies industry. The key to extant during this changing business setting is to know the variations between yourself and your competitors within the Autologous Stem Cell Based Therapies Market. The deep research study of Autologous Stem Cell Based Therapies market based on development opportunities, growth limiting factors and feasibility of investment will forecast the Autologous Stem Cell Based Therapies market growth.

Finally, The global research document on the Autologous Stem Cell Based Therapies Market discovers a large set of information regarding the competitive business environment and other substantial components. The prime aim of these major competitors is to focus on improved technologies and newer innovations.

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Study on Autologous Stem Cell Based Therapies Market (impact of COVID-19) 2020-2026 Brainstorm Cell Therapeutics, Tigenix, Med cell Europe - Bandera...

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Here are the drugs that could treat coronavirus. But don’t expect a silver bullet. – The Philadelphia Inquirer

By daniellenierenberg

Many in the medical community view an experimental antiviral drug called remdesivir, manufactured by Gilead Sciences, as the best chance for a treatment. In tests in academic labs, in work sponsored by the federal government, it has been shown to block viral replication. A clutch of clinical trials are underway worldwide to test it in patients, and Gilead is distributing it to thousands of people on a "compassionate use" basis. Remdesivir is considered a broad-spectrum antiviral, meaning it is believed to work against multiple types of virus. But it failed in a test against Ebola last year. Also, it has a big drawback: It is a liquid that must be given intravenously, which means people must go to a hospital or clinic on 10 consecutive days to be treated. Gilead, the National Institutes of Health and the World Health Organization are among those sponsoring multiple clinical trials, and preliminary results are expected within weeks.

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Liver Cirrhosis Market Projected to Gain Significant Value by 2024 – Science In Me

By daniellenierenberg

Advance Market Analyticsreleased the research report ofGlobal Liver CirrhosisMarket, offers a detailed overview of the factors influencing the global business scope.Global Liver Cirrhosis Market research report shows the latest market insights with upcoming trends and breakdown of the products and services.The report provides key statistics on the market status, size, share, growth factors of the Global Liver Cirrhosis.This Report covers the emerging players data, including: competitive situation, sales, revenue and global market share of top manufacturers are F. Hoffmann-La Roche AG (Switzerland), Merck & Co., Inc (United States), Abbott Laboratories (United States), Novartis International AG (Switzerland), Bristol Myers Squibb Company (United States), Gilead Sciences, Inc (United States), Conatus Pharmaceuticals (United States), GlaxoSmithKline plc (United Kingdom), Grifols, S.A. (Spain), GWOXI Stem Cell Applied Technology Co., Ltd (China), Hepion Pharmaceuticals (United States), Intercept Pharmaceuticals, Inc. (United States) and Lepu Medical Technology (Beijing) Co., Ltd. (China).

Free Sample Report + All Related Graphs & Charts @ https://www.advancemarketanalytics.com/sample-report/63193-global-liver-cirrhosis-market

The liver cirrhosis means the condition that causes scar tissue of the liver to replace healthy liver tissue cells, it happens over the period due to the chronic infection or alcohol addiction. It is diagnosed by various radiology tests such as computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), needle biopsy of the liver. A new imaging technique called elastography, which can be performed with ultrasound or MRI, can also diagnosis cirrhosis.

Market Trend

Market Drivers

Opportunities

Restraints

Challenges

The Global Liver Cirrhosisis segmented by following Product Types:

Type (Alcoholic Cirrhosis, Atrophic Cirrhosis, Biliary Cirrhosis, Cardiac Cirrhosis, Cryptogenic Cirrhosis), Application (Hospitals, Specialty Clinics, Others), Treatment (Self-care, Medications {Diuretic, Ammonia Reducer, Beta Blocker, Antibiotics, Antiviral Drug}, Medical procedure {Rubber Band Ligation, Therapeutic Endoscopy, and Transjugular Intrahepatic Portosystemic Shunt}, Surgery {Liver transplantation}), Stages (Stage 1, Stage 2, Stage 3, Stage 4), Tests (Computed Tomography (CT), Ultrasound, Magnetic Resonance Imaging (MRI), Needle Biopsy)

Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.Enquire for customization in Report @:https://www.advancemarketanalytics.com/enquiry-before-buy/63193-global-liver-cirrhosis-market

Strategic Points Covered in Table of Content of Global Liver Cirrhosis Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Global Liver Cirrhosis market

Chapter 2: Exclusive Summary the basic information of the Global Liver Cirrhosis Market.

Chapter 3: Displayingthe Market Dynamics- Drivers, Trends and Challenges of the Global Liver Cirrhosis

Chapter 4: Presenting the Global Liver Cirrhosis Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Global Liver Cirrhosis market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Global Liver Cirrhosis Market is a valuable source of guidance for individuals and companies.

Data Sources & Methodology

The primary sources involves the industry experts from the Global Liver Cirrhosis Market including the management organizations, processing organizations, analytics service providers of the industrys value chain. All primary sources were interviewed to gather and authenticate qualitative & quantitative information and determine the future prospects.

In the extensive primary research process undertaken for this study, the primary sources Postal Surveys, telephone, Online & Face-to-Face Survey were considered to obtain and verify both qualitative and quantitative aspects of this research study. When it comes to secondary sources Companys Annual reports, press Releases, Websites, Investor Presentation, Conference Call transcripts, Webinar, Journals, Regulators, National Customs and Industry Associations were given primary weight-age.

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Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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Our Analyst is tracking high growth study with detailed statistical and in-depth analysis of market trends & dynamics that provide a complete overview of the industry. We follow an extensive research methodology coupled with critical insights related industry factors and market forces to generate the best value for our clients. We Provides reliable primary and secondary data sources, our analysts and consultants derive informative and usable data suited for our clients business needs. The research study enable clients to meet varied market objectives a from global footprint expansion to supply chain optimization and from competitor profiling to M&As.

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Liver Cirrhosis Market Projected to Gain Significant Value by 2024 - Science In Me

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Stem Cell Therapy Market Set to Witness an Uptick during 2017 to 2025 – Science In Me

By daniellenierenberg

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

Know the Growth Opportunities in Emerging Markets

Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Cardiac Stem CellsHope for Congestive Heart Failure

By daniellenierenberg

it would be a good thing!

There are oodles of old rules in Cardiology. The provocateur in me loves it when dogma falls.

Niftier even, is when one can invoke the biology of newts to explain how yet another certainty was proven wrong.

As it turns out, those funny-looking mud-lovers possess a property that may revolutionize the treatment of heart disease. Unlike humans, newts can regrow damaged organs, including the heart! The newts organs contain cells that arent fully committed (biologists say terminally differentiated) to function.

Thats different than humans. Our organs, the heart among them, once damaged, do not recover. In humans, scar tissue replaces dead cells and the organ is diminished. This is how heart attacks result in heart failure: non-contracting scar tissue replaces the blood-starved (infarcted) muscle. This leads to a weaker pump (congestive heart failure) and susceptibility to rhythm problems (sudden death). Sadly, this process takes only an hour or so to occur. Hence the rush in stenting open a blocked artery.

Millions of heart patients suffer from weak hearts due to heart muscle damage. Until recently, most doctors held to the old belief that self-renewal of heart muscle is impossible. All doctors can do is micro-manage medicines and maybe implant risky defibrillators. The heart remains weak, the patient limited. The wordirreversibility.

Until recently that is.

New and emerging data reveals that our hearts may indeed have progenitor (stem) cells capable of growing into mature squeezing muscle cells. Call them, newt-like if you will.

Here goes the thinking: Unlike the newt, we humans cant signal heart stem cells to grow new muscle. But imagine if we could? Scar could be replaced with beating muscle, thereby restoring pump function. Heart attacks and heart muscle problems (cardiomyopathy), once thought permanently disabling, could be reversed like skin infections. Its like a fantasy.

Stem cells? Yes. I think its possible that cardiac stems cells may be the key that opens the treasure chest of the next generation of cardiac care. And how neat is it that my hometown, Louisville KY, happens to be at the epicenter of stem cell research?

Dr Roberto Bolli, a hard-working, self-made research scientist from Italy, who now chairs the Department of Cardiology at the University of Louisville has broken exciting new ground. His teams work, published in the journal, Lancet, has brought new momentum to the dreamy possibility of using cardiac stem cells to regrow damaged heart muscle.

Dr Bollis study (called SCIPIO) was the first in-man study of heart-derived stem cells. Previous stem cell studies used animal models, or those done in humans used bone marrow cells rather than heart cells.

Heres my brief synopsis of the Lancet study:

The U of L researchers enrolled patients with prior heart attacks and weakened hearts that were referred for bypass surgery. During surgery, a sample of the heart was cut out, sent to Boston where the cardiac stem cells were isolated. (This process involves serious biochemistry, above my pay grade; I like to think of the sample as being juiced down to the stem cells.). At four months, time enough for improvement from bypass to have occurred, one group (16 patients) underwent heart cath where a balloon angioplasty catheter was used to infuse a syringe full of the patients own (1 million) stem cells. The control group (7 patients) had standard bypass but no stem cell infusions.

The results were striking:

Compared to the control subjects who showed no improvement in heart function during the follow-up period (1 year), those who received stem cells sustained significant improvements in heart function, physical capacity and scored better on quality of life questionnaires. Most remarkably, ultrasound and MRI imaging revealed the areas where stem cells were infused showed the most improvement, and the enhanced squeezing function continued over the year. There were no safety issues with stem cell infusions.

These findings led the authors to conclude that cardiac stem cells induced regeneration of heart muscle.

Wow.

I have to admit that my knee-jerk reaction tended towards naysaying. No way could this work, I thought. The study involved only 16 patients followed for only a year. Lots of limitations. Very preliminary.

But after spending a couple of hours reading about the biology of stem cells, Im pretty excited about the Louisville research. For instance, I learned that injected stem cells might not have to en-graft themselves into the scar, rather they may signal the native heart to repair itself. Biologists call this a paracrine function.

Dr Bolli told our local paper that he has been besieged with letters from desperate patients with weakened hearts. Promising press reports on very early research tend to amplify hope. Rightly, Dr Bolli emphasizes the preliminary nature of this work. He adds that the SCIPIO study is ongoing and more data is forthcoming.

Its surely way too early to speculate on whether this novel approach evolves into Cardiologys Facebook or iPhone.

We will see. But let it be known that I am marking this post with a new category, Cardiac stem cells. Im keeping my eye on this exciting topic.

Put me down as optimistic and hopefulthe heart-healthy outlook.

JMM

Disclosure: I dont own Baxter stock.

h/t to Larry Husten (@cardiobrief)

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Merck Receives Priority Review from FDA for Second Application for KEYTRUDA (pembrolizumab) Based on Biomarker, Regardless of Tumor Type – Benzinga

By daniellenierenberg

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 16, 2020.

"From the start, biomarker research has been a critical aspect of our clinical program evaluating KEYTRUDA monotherapy," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "TMB has been an area of scientific interest to help identify patients most likely to benefit from KEYTRUDA. We look forward to working with the FDA throughout the review process to help bring KEYTRUDA monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited."

The application was based in part on results from the Phase 2 KEYNOTE-158 trial, which also supported Merck's 2017 FDA approval for KEYTRUDA as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. MSI-H is on the highest end of the TMB spectrum. Data from KEYNOTE-158 on the TMB-H patient population were presented at the European Society for Medical Oncology (ESMO) 2019 Congress.

About KEYNOTE-158

KEYNOTE-158 (NCT02628067) is a multicenter, multi-cohort, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks) in patients with solid tumors. Tissue TMB status was determined using the Foundation Medicine, Inc. FoundationOneCDx assay. Tumor response was assessed every nine weeks per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent, central, blinded radiographic review. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

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

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

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High (MSI-H) Cancer

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

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

Gastric Cancer

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

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

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

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

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

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

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

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

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

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

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

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

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

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

More:
Merck Receives Priority Review from FDA for Second Application for KEYTRUDA (pembrolizumab) Based on Biomarker, Regardless of Tumor Type - Benzinga

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market: Incredible Possibilities, Growth With Industry Study, Detailed Analysis And Forecast To…

By daniellenierenberg

The Autologous Stem Cell and Non-Stem Cell Based Therapies market research encompasses an exhaustive analysis of the market outlook, framework, and socio-economic impacts. The report covers the accurate investigation of the market size, share, product footprint, revenue, and progress rate. Driven by primary and secondary researches, the Autologous Stem Cell and Non-Stem Cell Based Therapies market study offers reliable and authentic projections regarding the technical jargon.

All the players running in the global Autologous Stem Cell and Non-Stem Cell Based Therapies market are elaborated thoroughly in the Autologous Stem Cell and Non-Stem Cell Based Therapies market report on the basis of proprietary technologies, distribution channels, industrial penetration, manufacturing processes, and revenue. In addition, the report examines R&D developments, legal policies, and strategies defining the competitiveness of the Autologous Stem Cell and Non-Stem Cell Based Therapies market players.

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The major players profiled in this report include:U.S. STEM CELL, INC.Brainstorm Cell TherapeuticsCytoriDendreon CorporationFibrocellLion BiotechnologiesCaladrius BiosciencesOpexa TherapeuticsOrgenesisRegenexxGenzymeAntriaRegeneusMesoblastPluristem Therapeutics IncTigenixMed cell EuropeHolostemMiltenyi Biotec

The end users/applications and product categories analysis:On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-Embryonic Stem CellResident Cardiac Stem CellsAdult Bone MarrowDerived Stem CellsUmbilical Cord Blood Stem Cells

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Autologous Stem Cell and Non-Stem Cell Based Therapies for each application, including-Neurodegenerative DisordersAutoimmune Diseases Cancer and TumorsCardiovascular Diseases

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Objectives of the Autologous Stem Cell and Non-Stem Cell Based Therapies Market Study:

The Autologous Stem Cell and Non-Stem Cell Based Therapies market research focuses on the market structure and various factors (positive and negative) affecting the growth of the market. The study encloses a precise evaluation of the Autologous Stem Cell and Non-Stem Cell Based Therapies market, including growth rate, current scenario, and volume inflation prospects, on the basis of DROT and Porters Five Forces analyses. In addition, the Autologous Stem Cell and Non-Stem Cell Based Therapies market study provides reliable and authentic projections regarding the technical jargon.

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After reading the Autologous Stem Cell and Non-Stem Cell Based Therapies market report, readers can:

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market: Incredible Possibilities, Growth With Industry Study, Detailed Analysis And Forecast To...

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Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of…

By daniellenierenberg

CAMBRIDGE, England--(BUSINESS WIRE)--Metrion Biosciences Limited (Metrion), the specialist ion channel CRO and drug discovery company, today announced it has contributed to two new peer-reviewed papers under the U.S. Food and Drug Administrations (FDA) CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. The papers, in Nature Scientific Reports1 and Toxicology and Applied Pharmacology2, focus on application of improved cardiac safety testing protocols and recommendations for best practice for the drug discovery industry.

The CiPA Initiative (www.cipaproject.org), which began in July 2013 following a workshop at the US FDA, has the objective to revise and enhance the regulatory framework assessing cardiac safety of new chemical entities. Under current guidelines, new therapeutics undergo initial assessment of proarrhythmic risk by measuring activity against the hERG cardiac ion channel, before progressing to studies in preclinical animal models and ultimately, a Thorough QT interval study in the clinic. The CiPA initiative aims to extend the use of advances in early electrophysiology-based cardiac ion channel screening, in silico predictive modelling, and human induced pluripotent stem cell derived cardiomyocytes to improve the accuracy and reduce the cost of predicting the cardiac liability of new drug candidates. Metrions research forms part of the first stage of the proposed harmonisation work, to provide clarity on how to standardise cardiac ion channel assays to ensure they deliver consistent data for in silico models of clinical cardiac arrythmia risk.

The first paper1, published in Nature Scientific Reports on 27th March 2020 by an international group of authors drawn from 20 different commercial and academic laboratories, including Metrion Biosciences, was coordinated by the Health and Environmental Sciences Institute (HESI). It reviews data from a multi-year, multi-site collaboration across industry, academia and the FDA regulatory agency to optimize experimental protocols and reduce experimental variability and bias. The goal of the study was to guide the development of best practices for the use of automated patch clamp technologies in early cardiac safety screening. High quality in vitro cardiac ion channel data is required for accurate and reliable characterisation of the risk of delayed repolarisation and proarrhythmia in the human heart and to guide subsequent clinical studies and regulatory submissions.

The second paper2, to be published formally in Toxicology and Applied Pharmacology paper on 1st May 2020 but currently available online, uses automated patch clamp data from the CiPA consortium to address the lack of statistical quantification of variability, which hinders the use of primary hERG potency data to predict cardiac arrhythmia. The consortium establishes a more systematic approach to estimate hERG block potency and safety margins.

Dr Marc Rogers, CSO, Metrion Biosciences, said: The Metrion team has been a participant in the international CiPA Initiative since inception and we are now pleased to be able to announce the publication of our data from this global collaborative scientific effort. We believe these projects will make a significant contribution to the eventual revision of cardiac safety testing guidelines by the FDA and other international regulatory agencies. They also contribute to deepening our knowledge of the underlying causes of proarrhythmia, which will help prevent early attrition of potentially promising drugs.

Contributing organisations to the Nature Scientific Reports CiPA study include: Charles River Laboratories; Bayer AG; Sophion Bioscience A/S; Nanion Technologies; GlaxoSmithKline PLC; Pfizer; Sanofi R&D; Astra Zeneca; BSYS GmbH; Bristol-Myers Squibb Company; Eurofins Discovery; Merck; Metrion Biosciences Ltd.; Natural and Medical Science Institute at the University of Tbingen; Northwestern Feinberg School of Medicine, Chicago; Roche Innovation Center Basel; Novoheart; Health and Environmental Sciences Institute, Washington, DC; AbbVie.

Contributing organisations to the Toxicology and Applied Pharmacology hERG study include: Center for Drug Evaluation and Research, Food and Drug Administration; Eli Lilly and Company; AstraZeneca; CiPA LAB; NMI-TT GmbH; Sophion Bioscience A/S; B'SYS GmbH; The Ion Channel Company; F. Hoffmann-La Roche AG; Eurofins Discovery; Bristol-Myers Squibb; Merck & Co., Inc; Metrion Biosciences Ltd.; Nanion Technologies; Charles River Laboratories; Bayer AG; University of Nottingham; Universit de Lille.

For more information on Metrions fully integrated Cardiac Safety Screening / CiPA Screening service, please visit: https://www.metrionbiosciences.com/services/cardiac-safety-screening/

Merion Biosciences comprehensive cardiac safety testing White Paper The changing landscape of cardiac safety will also be available on the Companys website from 13th April 2020.

Link:
Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of...

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market [News 2020] Intelligence and Future Prospects 2025 – Fashion Trends News

By daniellenierenberg

Autologous Stem Cell and Non-Stem Cell Based Therapies Market research report covers the existing situation and the development predictions of the industry for 2020. This report has prepared mainly on the basis of a common market assessment with input from industry experts. This estimated report consists of all have observed element about marketplace evaluation, increase Demand and forecast analysis in all over the world. This record gives a few edged examine and solution within the complicated international of polymer-based totally thermal interface materials market.

Report Covers Following Key Players:-

U.S. STEM CELL, INC., Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Lion Biotechnologies, Caladrius Biosciences, Opexa Therapeutics, Orgenesis, Regenexx, Genzyme, Antria, Regeneus, Mesoblast, Pluristem Therapeutics Inc, Tigenix, Med cell Europe, Holostem, Miltenyi Biotec.

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>> [ Conjointly enclosed free report contains a quick introduction to the abstract, table of contents, list of tables and figures, competitive landscape and geographic segmentation, innovation and future developments supported the methodology of investigation.] <<

The market report defines the growth of the industry by upstream and downstream, by the industry as a whole and by production, by key companies as well as by product segment and application, and so on, and makes a scientific forecast for the technology industry on the basis of an analysis.

Autologous Stem Cell and Non-Stem Cell Based Therapies Market research report quantifies opportunities and Challenges to prioritize with the revenue. The report describes each aspect in depth, such as Business Strategies, Market Trends, Regional Growth, Quality Matrix. This vital data about Autologous Stem Cell and Non-Stem Cell Based Therapies industry will help to improve market growth in terms of manufacturing capacity, Sales during the Forecast period of 2020.

Market Segment by Regions:-

USAEuropeJapanChinaIndiaSoutheast Asia

Scope of the Report:

This study focuses on the global market for Autologous Stem Cell and Non-Stem Cell Based Therapies especially in Europe, North America and Asia-Pacific, the Middle East and Africa, and South America. The report defines the market based on regions, size, manufacturers and applications.

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Market Segment On The Basis Of Product Type Includes:-

Embryonic Stem CellResident Cardiac Stem CellsAdult Bone MarrowDerived Stem CellsUmbilical Cord Blood Stem Cells

Applications Mentioned In This Report:-

Neurodegenerative DisordersAutoimmune DiseasesCancer and TumorsCardiovascular Diseases

The report then estimates 2020 market development trends of Autologous Stem Cell and Non-Stem Cell Based Therapies market. Outline of upstream raw materials, downstream trade and prevailing market dynamics is also carried out. In the end, the report makes some important proposals for a new project of Autologous Stem Cell and Non-Stem Cell Based Therapies market before evaluating its feasibility.

This report presents an extensive analysis of the current Autologous Stem Cell and Non-Stem Cell Based Therapies trends and emerging estimations & dynamics of the global Autologous Stem Cell and Non-Stem Cell Based Therapies industry. Likewise, explains the comprehensive analysis of factors that drive and restrict the growth of the Autologous Stem Cell and Non-Stem Cell Based Therapies market. Further covers a detailed analysis of the Autologous Stem Cell and Non-Stem Cell Based Therapies industry based on type and application help in understanding the Autologous Stem Cell and Non-Stem Cell Based Therapies trending products across geographies. Then highlights the potency of buyers and suppliers to understand the Autologous Stem Cell and Non-Stem Cell Based Therapies market potency. Finally, an extensive analysis of the Autologous Stem Cell and Non-Stem Cell Based Therapies market is conducted by key product positioning and monitoring of top players within the Autologous Stem Cell and Non-Stem Cell Based Therapies market framework.

Table of Contents:

1 Industry Overview of Autologous Stem Cell and Non-Stem Cell Based Therapies.2 Global Autologous Stem Cell and Non-Stem Cell Based Therapies Competition Analysis by Players.3 Company (Top Players) Profiles.4 Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market Size by Type and Application (2020-2025).5 United States Autologous Stem Cell and Non-Stem Cell Based Therapies Development Status and Outlook.6 EU Ophthalmology DiagnosticsDevelopment Status and Outlook.7 Japan Autologous Stem Cell and Non-Stem Cell Based Therapies Development Status and Outlook.8 China Autologous Stem Cell and Non-Stem Cell Based Therapies Development Status and Outlook.9 India Autologous Stem Cell and Non-Stem Cell Based Therapies Development Status and Outlook.10 Southeast Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Development Status and Outlook.11 Market Forecast by Regions, Type, and Application (2020-2025).12 Autologous Stem Cell and Non-Stem Cell Based Therapies Market Dynamics.13 Market Effect Factors Analysis.14 Research Finding/Conclusion.15 Appendix.

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market [News 2020] Intelligence and Future Prospects 2025 - Fashion Trends News

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Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) – Publicist360

By daniellenierenberg

Global Stem Cell Reconstructive Market was valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 24.5% during a forecast period.

Global Stem Cell Reconstructive Market

Market Dynamics

The Research Report gives an in-depth account of the drivers and restraints in the stem cell reconstructive market. Stem cell reconstructive surgery includes the treatment of injured or dented part of body. Stem cells are undifferentiated biological cells, which divide to produce more stem cells. Growing reconstructive surgeries led by the rising number of limbs elimination and implants and accidents are boosting the growth in the stem cell reconstructive market. Additionally, rising number of aged population, number of patients suffering from chronic diseases, and unceasing development in the technology, these are factors which promoting the growth of the stem cell reconstructive market. Stem cell reconstructive is a procedure containing the use of a patients own adipose tissue to rise the fat volume in the area of reconstruction and therefore helping 3Dimentional reconstruction in patients who have experienced a trauma or in a post-surgical event such as a mastectomy or lumpectomy, brain surgery, or reconstructive surgery as a result of an accident or injury. Stem cell reconstructive surgeries are also used in plastic or cosmetic surgeries as well. Stem cell and regenerative therapies gives many opportunities for development in the practice of medicine and the possibility of an array of novel treatment options for patients experiencing a variety of symptoms and conditions. Stem cell therapy, also recognised as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.

The common guarantee of all the undifferentiated embryonic stem cells (ESCs), foetal, amniotic, UCB, and adult stem cell types is their indefinite self-renewal capacity and high multilineage differentiation potential that confer them a primitive and dynamic role throughout the developmental process and the lifespan in adult mammal.However, the high expenditure of stem cell reconstructive surgeries and strict regulatory approvals are restraining the market growth.

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Global Stem Cell Reconstructive Market Segment analysis

Based on Cell Type, the embryonic stem cells segment is expected to grow at a CAGR of XX% during the forecast period. Embryonic stem cells (ESCs), derived from the blastocyst stage of early mammalian embryos, are distinguished by their capability to distinguish into any embryonic cell type and by their ability to self-renew. Owing to their plasticity and potentially limitless capacity for self-renewal, embryonic stem cell therapies have been suggested for regenerative medicine and tissue replacement after injury or disease. Additionally, their potential in regenerative medicine, embryonic stem cells provide a possible another source of tissue/organs which serves as a possible solution to the donor shortage dilemma. Researchers have differentiated ESCs into dopamine-producing cells with the hope that these neurons could be used in the treatment of Parkinsons disease. Upsurge occurrence of cardiac and malignant diseases is promoting the segment growth. Rapid developments in this vertical contain protocols for directed differentiation, defined culture systems, demonstration of applications in drug screening, establishment of several disease models, and evaluation of therapeutic potential in treating incurable diseases.

Global Stem Cell Reconstructive Market Regional analysis

The North American region has dominated the market with US$ XX Mn. America accounts for the largest and fastest-growing market of stem cell reconstructive because of the huge patient population and well-built healthcare sector. Americas stem cell reconstructive market is segmented into two major regions such as North America and South America. More than 80% of the market is shared by North America due to the presence of the US and Canada.

Europe accounts for the second-largest market which is followed by the Asia Pacific. Germany and UK account for the major share in the European market due to government support for research and development, well-developed technology and high healthcare expenditure have fuelled the growth of the market. This growing occurrence of cancer and diabetes in America is the main boosting factor for the growth of this market.

The objective of the report is to present a comprehensive analysis of the Global Stem Cell Reconstructive Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.

The report also helps in understanding Global Stem Cell Reconstructive Market dynamics, structure by analysing the market segments and projects the Global Stem Cell Reconstructive Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Stem Cell Reconstructive Market make the report investors guide.Scope of the Global Stem Cell Reconstructive Market

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Global Stem Cell Reconstructive Market, By Sources

Allogeneic Autologouso Bone Marrowo Adipose Tissueo Blood Syngeneic OtherGlobal Stem Cell Reconstructive Market, By Cell Type

Embryonic Stem Cell Adult Stem CellGlobal Stem Cell Reconstructive Market, By Application

Cancer Diabetes Traumatic Skin Defect Severe Burn OtherGlobal Stem Cell Reconstructive Market, By End-User

Hospitals Research Institute OthersGlobal Stem Cell Reconstructive Market, By Regions

North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Stem Cell Reconstructive Market

Osiris Therapeutics NuVasives Cytori Therapeutics Takeda (TiGenix) Cynata Celyad Medi-post Anterogen Molmed Baxter Eleveflow Mesoblast Ltd. Micronit Microfluidics TAKARA BIO INC. Tigenix Capricor Therapeutics Astellas Pharma US, Inc. Pfizer Inc. STEMCELL Technologies Inc.

MAJOR TOC OF THE REPORT

Chapter One: Stem Cell Reconstructive Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Stem Cell Reconstructive Market Competition, by Players

Chapter Four: Global Stem Cell Reconstructive Market Size by Regions

Chapter Five: North America Stem Cell Reconstructive Revenue by Countries

Chapter Six: Europe Stem Cell Reconstructive Revenue by Countries

Chapter Seven: Asia-Pacific Stem Cell Reconstructive Revenue by Countries

Chapter Eight: South America Stem Cell Reconstructive Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Stem Cell Reconstructive by Countries

Chapter Ten: Global Stem Cell Reconstructive Market Segment by Type

Chapter Eleven: Global Stem Cell Reconstructive Market Segment by Application

Chapter Twelve: Global Stem Cell Reconstructive Market Size Forecast (2019-2026)

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Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) - Publicist360

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Anti-IL-6 Monoclonal Antibodies as Antiarrhythmic Treatment for HF – The Cardiology Advisor

By daniellenierenberg

, which were found to produce high levels of Interleukin-6 (IL-6), was abated in the presence of anti-IL-6 monoclonal antibodies, according to study results intended to be presented at the annual meeting of the American College of Cardiology (ACC.20).

In a diseased state, cardiacmesenchymal stromal cells (cMSCs) remodel and secrete inflammatory cytokines,including IL-6. IL-6 has been shown to be a potent inducer of Ca2+-mediatedarrhythmia substrates in human myocytes. While anti-IL-6 monoclonal antibodies havean established role in the treatment of autoimmune diseases and malignancies, theiruse in the treatment of cardiac disease has not been well studied.

Using extracted device leads and explanted hearts from patients with and without heart failure, investigators isolated cMSCs (failing and non-failing cMSCs, respectively), and quantified IL-6 using an enzyme-linked immunosorbent assay. Myocytes were derived from induced pluripotent stem cells (iPSCs) from individuals without heart failure and cultured in monolayers. Myocytes were treated with exogenous IL-6 or cocultured with failing cMSCs with and without anti-IL-6 monoclonal antibody. Fluorescent indicators were used to detect the presence of Ca2+ alternans during steady state pacing.

The secretion of IL-6 was found tobe 5.6 times higher in failing vs nonfailing cMSCs (n=4; P <.005) and 66 times higher in cMSCs vs iPSC-derived humanmyocytes (n=5; P <.002). Myocytes thatwere cocultured with failing cMSCs or were exposed to exogenous IL-6 had largeincreases in Ca2+ alternans compared with myocytes cultured alone (343%,n=12, P <.001 and 300%, n=5, P <.002, respectively). These Ca2+alternans were reduced to baseline levels in myocyte/cMSC cocultures treated vsnot treated with IL-6 (reduction, 400%; n=18, P <.001).

These results suggest anovel anti-arrhythmic therapeutic strategy in heart failure using anti-IL-6drugs such as tocilizumab, sarilumab, or siltuximab, concluded theresearchers.

Reference

Vasireddi S, Sattayaprasert P,Moravec C, et al. Targeted anti-inflammatory treatment with anti-Il-6monoclonal antibody for calcium-mediated arrhythmia substrates in heartfailure. Intended to be presented at: American College of Cardiologys 69thAnnual Scientific Session; March 28-30, 2020; Chicago, IL. Presentation 915-09.

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Anti-IL-6 Monoclonal Antibodies as Antiarrhythmic Treatment for HF - The Cardiology Advisor

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Global Autologous Cell Therapy Market 2020-2024 | Evolving Opportunities with Bayer AG and Brainstorm Cell Therapeutics Inc. | Technavio – Business…

By daniellenierenberg

LONDON--(BUSINESS WIRE)--The global autologous cell therapy market is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. Request free sample pages

Read the 120-page report with TOC on "Autologous Cell Therapy Market Analysis Report by Therapy (Autologous stem cell therapy and Autologous cellular immunotherapies), Application (Oncology, Musculoskeletal disorders, and Dermatology), Geography (North America, APAC, Europe, South America, and MEA), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/autologous-cell-therapy-market-industry-analysis

The market is driven by the increasing demand for effective drugs for cardiac and degenerative disorders. In addition, the limitations in traditional organ transplantations are fueling the demand for stem cell therapies. All these factors are anticipated to boost the growth of the autologous cell therapy market.

The demand for effective drugs for cardiac and degenerative disorders has been increasing across the world. In addition, the discovery of possible cardiac autologous cells has enabled vendors to develop novel drugs for the treatment of various cardiac diseases. For instance, Mesoblast is developing MPC-150-IM. It is a Phase III candidate for the treatment of advanced and end-stage chronic heart failure. Similarly, Shire has been developing autologous stem cell therapies for chronic myocardial ischemia. These products are expected to be launched during the forecast period and will have a positive impact on the growth of the global autologous cell therapy market.

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View market snapshot before purchasing

Major Five Autologous Cell Therapy Market Companies:

Bayer AG

Bayer AG operates its business through segments such as Pharmaceuticals, Crop Science, Consumer Health, and Animal Health. The company offers induced pluripotent stem cells. They are developed by reprogramming mature body cells to behave like embryonic stem cells that are injected to restore diseased tissue in patients.

Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. operates its business through an unified business segment. NurOwn is the key offering of the company. It is a cell therapy platform, which develops mesenchymal stem cells for the treatment of human diseases such as immune and inflammatory diseases.

Daiichi Sankyo Co. Ltd.

Daiichi Sankyo Co. Ltd. operates its business through segments such as Innovative Pharmaceuticals, Generic, Vaccine, and OTC Related. Heartcel is the key offering of the company. It is an immune-modulatory progenitor cell therapeutic agent, which is used for ischemic heart failure.

FUJIFILM Holdings Corp.

FUJIFILM Holdings Corp. operates its business through segments such as Imaging solutions, Healthcare and material solutions, and Document solutions. The company uses induced pluripotent stem cells to derive differentiated cells, which are used in researching various diseases and conditions.

Holostem Terapie Avanzate Srl

Holostem Terapie Avanzate Srl operates its business through an unified business segment. Holoclar is the key offering of the company. It is an advanced therapy medicinal product containing stem cells indicated to repair the cornea after injury.

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Autologous Cell Therapy Market Therapy Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Application Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Regional Outlook (Revenue, USD Billion, 2020-2024)

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Related Reports on Healthcare Include:

Global Cancer Stem Cell Therapeutics Market Global cancer stem cell therapy market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

Global Mantle Cell Lymphoma Therapeutics Market Global mantle cell lymphoma therapeutics market by product (combination therapy and monotherapy) and geography (Asia, Europe, North America, and ROW).

About Technavio

Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

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Global Autologous Cell Therapy Market 2020-2024 | Evolving Opportunities with Bayer AG and Brainstorm Cell Therapeutics Inc. | Technavio - Business...

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Regenerative Medicine Market Demand, Growth, Opportunities and Analysis Of Top Key Player Forecast To 2025 – Daily Science

By daniellenierenberg

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe areVericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc.A large number of players are anticipated to enter the global market throughout the forecast period.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Autologous Stem Cell Based Therapies Market Cost Profit and Marginal Revenue Analysis 2020-2026 Brainstorm Cell Therapeutics, Tigenix, Med cell Europe…

By daniellenierenberg

The latest report on the Global Autologous Stem Cell Based Therapies Market Report 2020-2026 is a systematic and insightful compilation of valuable evaluations of Autologous Stem Cell Based Therapies market and relevant aspects. The report offers an in depth exploration of the market and its scope, trends, structure, production, profitability and maturity. The precise evaluation of market size, share, revenue, sales volume, demand, and rate of growth involved within the report drive investors, industry experts, researchers, also as novice and well-established market players to grasp the general Autologous Stem Cell Based Therapies market structure.

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The Autologous Stem Cell Based Therapies market report also delivers an in-depth analysis of the emerging industry trends along side the restraints, drivers, and opportunities within the Autologous Stem Cell Based Therapies market to supply worthwhile insights also as a gift scenario for generating right decision. Moreover, the new report on the Autologous Stem Cell Based Therapies industry covers the prominent vendors within the universal market alongside SWOT analysis, fiscal overview and major developments.

The global Autologous Stem Cell Based Therapies Market report is considered as a detailed investigation of the respective market that will provide key solutions for establishment of profit-driven business strategies. It is helpful for offering details about futuristic Autologous Stem Cell Based Therapies industry trends and in-depth assessment of the international industry. It permits you to determine remarkable challenges and risk factors alongside major opportunities available in the world Autologous Stem Cell Based Therapies market. This report also exhibits the whole historical and current status of the Autologous Stem Cell Based Therapies Market globally. Apart from this, the report on the Autologous Stem Cell Based Therapies industry also represents the graphical representation of the upcoming Autologous Stem Cell Based Therapies Market infrastructure and the Compound Annual Growth Rate (CAGR) in detail.

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The report on the Autologous Stem Cell Based Therapies market is an exclusive and deep study which delivers a comprehensive overview of the industry contains the recent trends and future proportions of the Autologous Stem Cell Based Therapies market in terms of product and services. Meanwhile, this report offers a professional research study on the Autologous Stem Cell Based Therapies market so as to guage the remarkable vendors by calibrating all the relevant products or services to know the positioning of the key players within the Autologous Stem Cell Based Therapies market globally.

Leading companies reviewed in the Autologous Stem Cell Based Therapies report are:

RegeneusMesoblastPluristem Therapeutics IncU.S. STEM CELL, INC.Brainstorm Cell TherapeuticsTigenixMed cell Europe

The Autologous Stem Cell Based Therapies Market market report is segmented into following categories:

The product segment of the report offers product market information such as demand, supply and market value of the product.

The application of product in terms of USD value is represented in numerical and graphical format for all the major regional markets.The Autologous Stem Cell Based Therapies market report is segmented into Type by following categories;Embryonic Stem CellResident Cardiac Stem CellsUmbilical Cord Blood Stem Cells

The Autologous Stem Cell Based Therapies market report is segmented into Application by following categories;Neurodegenerative DisordersAutoimmune DiseasesCardiovascular Diseases

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The global Autologous Stem Cell Based Therapies marketing research report offers an in depth summary of the foremost desirable factors and informative details about the universal industry. Moreover, the study provides an in-depth summary and forecast of the worldwide Autologous Stem Cell Based Therapies market on the idea of several segments. This report also delivers Autologous Stem Cell Based Therapies market size and predicted estimations from the year 2020 to 2026 concerning various topological regions including Europe, North America, the center East and Africa, and South America.

The research study on the Autologous Stem Cell Based Therapies Market is a valuable source of guidance for global customers as it will rapidly fulfil their requirement and speed up their business growth. It is an advantageous document for both existing industries manufactures including end-user industries, experts, managers, stakeholders and new entrants. We have designed this global Autologous Stem Cell Based Therapies Market report in a deeply understandable format so that anyone can grasp each and every aspect related to the respective industry

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Autologous Stem Cell Based Therapies Market Cost Profit and Marginal Revenue Analysis 2020-2026 Brainstorm Cell Therapeutics, Tigenix, Med cell Europe...

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While we were stockpiling, here’s what astronauts were up to in space last week – CNN

By daniellenierenberg

While many of us are practicing social distancing, working from home or living in quarantine-like and isolated situations, life goes on as normal for the space station-dwelling astronauts.

They're aware of the pandemic and have been sharing their support for people across the globe through their Twitter accounts. NASA astronaut Jessica Meir shared her perspective: "From up here, it is easy to see that we are truly all in this together. #EarthStrong."

But the astronauts aren't just floating around and taking cool pictures of Earth. Each week, hundreds of science experiments are in progress on the station. In addition to working on these experiments, the astronauts study themselves to better understand the human body in space.

Here's a look at the cool science they've been doing 254 miles from Earth.

Space pants

Living in space is an adjustment for the human body as it adapts to the lack of gravity.

Over the years, astronauts have noticed changes in their vision as a response to the headward fluid shift they experience. This also increases pressure in the head.

Last week, NASA astronauts Jessica Meir and Andrew Morgan, as well as Russian cosmonaut Oleg Skripochka, tested out the Russian Chibis hardware, also known as the Russian Space Agency's Lower Body Negative Pressure experiment.

It's basically a pair of pants housed in the Russian Orbital Segment of the space station.

The rubber pants use suction to draw fluids back down towards the legs and feet, just like we experience walking on Earth.

Researchers hope that hardware to reverse the fluid shift astronauts experience in space could also help with their vision changes.

While Morgan was wearing the Chibis pants, Meir used a tonometer to measure his eye pressure, with doctors on Earth watching in real time. Morgan's head and chest were also scanned to monitor blood flow.

The astronauts also tested their hearing as part of the European Space Agency's Acoustic Diagnostics experiment to monitor if the astronauts' hearing changes in response to noise and lack of gravity on the station.

Heart, muscle and bone

Multiple experiments are currently occurring on the station that could not only benefit the health of astronauts, but human life on Earth as well.

These cells could treat astronauts who experience heart abnormalities and be used to treat people and children with cardiac diseases and disorders on Earth. The cells can also be used to investigate the development of new pharmaceuticals.

One experiment, called Engineered Heart Tissues, allows the astronauts to watch heart cell muscle contractions in real time.

Meir and Morgan have been taking care of the heart cells, watching how they react to the lack of gravity. When the heart cells return to Earth, the results of the space experiment will be compared with a similar control experiment on Earth.

The astronauts have also been studying bone samples to understand and develop bone treatments for astronauts who suffer bone loss in space, as well as people diagnosed with osteoporosis on Earth. The goal is to determine new treatments for both.

Mice are also sharing space on the station with the astronauts in a mouse habitat so they can study how the mice and their gene expression reacts to zero gravity.

Understanding how their gene expression is altered can help NASA better prepare for long-term human spaceflight. The study also serves a secondary purpose of allowing them to determine countermeasures for muscle atrophy, which can occur in space or for patients on bed rest.

It's all in your gut

Astronauts don't get much of a chance to vary their diets in space. That means they could also be missing out on vital nutrients and other added benefits of the fresh food we consume on Earth.

The Japanese space agency's Probiotics investigation is studying how good gut bacteria could improve the human microbiome on long-term missions.

Meanwhile, the astronauts are also participating in an experiment called Food Acceptability, looking at the "menu fatigue" that happens when they eat based on limited options over months on the station. This usually causes them to lose weight by the time they return to Earth.

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While we were stockpiling, here's what astronauts were up to in space last week - CNN

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Global Autologous Cell Therapy Market 2020-2024 | Evolving Opportunities with Bayer AG and Brainstorm Cell Therapeutics Inc. | Technavio – Yahoo…

By daniellenierenberg

The global autologous cell therapy market is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. Request free sample pages

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200323005764/en/

Technavio has published a latest market research report titled Global Autologous Cell Therapy Market 2020-2024 (Graphic: Business Wire)

Read the 120-page report with TOC on "Autologous Cell Therapy Market Analysis Report by Therapy (Autologous stem cell therapy and Autologous cellular immunotherapies), Application (Oncology, Musculoskeletal disorders, and Dermatology), Geography (North America, APAC, Europe, South America, and MEA), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/autologous-cell-therapy-market-industry-analysis

The market is driven by the increasing demand for effective drugs for cardiac and degenerative disorders. In addition, the limitations in traditional organ transplantations are fueling the demand for stem cell therapies. All these factors are anticipated to boost the growth of the autologous cell therapy market.

The demand for effective drugs for cardiac and degenerative disorders has been increasing across the world. In addition, the discovery of possible cardiac autologous cells has enabled vendors to develop novel drugs for the treatment of various cardiac diseases. For instance, Mesoblast is developing MPC-150-IM. It is a Phase III candidate for the treatment of advanced and end-stage chronic heart failure. Similarly, Shire has been developing autologous stem cell therapies for chronic myocardial ischemia. These products are expected to be launched during the forecast period and will have a positive impact on the growth of the global autologous cell therapy market.

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

View market snapshot before purchasing

Major Five Autologous Cell Therapy Market Companies:

Bayer AG

Bayer AG operates its business through segments such as Pharmaceuticals, Crop Science, Consumer Health, and Animal Health. The company offers induced pluripotent stem cells. They are developed by reprogramming mature body cells to behave like embryonic stem cells that are injected to restore diseased tissue in patients.

Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. operates its business through an unified business segment. NurOwn is the key offering of the company. It is a cell therapy platform, which develops mesenchymal stem cells for the treatment of human diseases such as immune and inflammatory diseases.

Daiichi Sankyo Co. Ltd.

Daiichi Sankyo Co. Ltd. operates its business through segments such as Innovative Pharmaceuticals, Generic, Vaccine, and OTC Related. Heartcel is the key offering of the company. It is an immune-modulatory progenitor cell therapeutic agent, which is used for ischemic heart failure.

FUJIFILM Holdings Corp.

FUJIFILM Holdings Corp. operates its business through segments such as Imaging solutions, Healthcare and material solutions, and Document solutions. The company uses induced pluripotent stem cells to derive differentiated cells, which are used in researching various diseases and conditions.

Story continues

Holostem Terapie Avanzate Srl

Holostem Terapie Avanzate Srl operates its business through an unified business segment. Holoclar is the key offering of the company. It is an advanced therapy medicinal product containing stem cells indicated to repair the cornea after injury.

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Autologous Cell Therapy Market Therapy Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Application Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Regional Outlook (Revenue, USD Billion, 2020-2024)

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Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness – P&T…

By daniellenierenberg

LEXINGTON, Mass., March 24, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx) announced that Leukine (sargramostim, rhu-GM-CSF)is being assessed in the SARPAC trial (sargramostim inpatients withacute hypoxic respiratory failure due toCOVID-19 EudraCT #2020-001254-22) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes.

"Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate," said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the Flanders Institute of Biotechnology (VIB). "We rapidly initiated this study with Leukine, because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms."

Granulocyte macrophage colony stimulating factor (GM-CSF) is essential for the health of the lungs. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining proper functioning of the immune system.1 GM-CSF confers resistance to influenza by enhancing innate immune mechanisms.2 In animal studies, GM-CSF reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia.3 In clinical studies, use of Leukine showed beneficial effects in patients with viral pneumonia.4,5 Recent data highlight the importance of understanding the immune status of patients and role of immunomodulating agents like GM-CSF to activate the immune system to help clear virus and reduce the risk of secondary infections.6

"Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort," said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. "We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues."

"In pre-clinical studies, GM-CSF protects the lungs from viral pneumonia and the influenza A virus", stated E. Scott Halstead, MD, PhD, Associate Professor, Penn State University College of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine. "Preliminary data indicate an apparent benefit of inhaled Leukine therapy for autoimmune pulmonary alveolar proteinosis ("aPAP") and suggest it has reduced the need for whole lung lavage therapy for patients receiving treatment. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID-19 and Influenza A."

For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomizedtrials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.

Leukine was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. In 2018, Leukine was approved for use as a medical countermeasure to treat Acute Radiation Syndrome (ARS) and has been procured for use by the U.S. Strategic National Stockpile. Leukine is distributed outside the U.S. on a named-patient basis through PTx's designated program manager, Tanner Pharma Group. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

About Leukine(sargramostim)Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

About Partner Therapeutics, Inc.: PTx is an U.S.-based commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.

References

Cited References

Other RelevantReferences

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SOURCE Partner Therapeutics, Inc.

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Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness - P&T...

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