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InGeneron Announces Publication of Preclinical Results for its Cell Therapy in Chronic Ischemic Heart Failure – Business Wire

By daniellenierenberg

HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a regenerative medicine and cell therapy company, today announced the publication of promising results in developing a novel treatment for chronic ischemic heart failure using its regenerative cell therapy platform.

A newly-released research paper published in the World Journal of Stem Cells provides missing pieces of evidence for a fundamental change in the treatment of chronic ischemic heart failure, showing efficacy and safety of a novel stem cell treatment in cardiology. Patients with heart failure as a consequence of previous myocardial infarction are a large and currently underserved patient population, due to the lack of regenerative treatment options.

The publication, performed in a pig model for the study of chronic myocardial infarction, evidences for the first time that regeneration of the damaged tissue in the heart - responsible for chronic ischemic heart failure - is possible. Specifically, the study demonstrates that InGenerons fresh, uncultured, autologous adipose derived regenerative cells (UA-ADRCs) - isolated and administered at point of care - provide a significant improvement of cardiac circulatory parameters in chronic ischemic heart failure. The results show that the mean cardiac output increased by 37%, the mean left ventricular mass increased by 29% and the mean relative amount of scar volume of the left ventricular wall decreased by 21% six weeks after treatment with the cells. All results were statistically significant compared to the control group. Notably, on average only 18 gram of adipose tissue were required to recover the averaged 18 million cells injected to achieve the reported effects.

The findings represent an important step in research, laying the foundation for new frontiers on cardiac regeneration of chronic ischemic heart failure in human patients. While previous studies indicated that stem cells (including UA-ADRCs) might be of benefit in acute myocardial infarction, this benchmark had previously not been achieved by studies of autologous stem cells for chronic heart failure following myocardial infarction.

Haenel et al., the authors of the publication, attribute the success of the study to two important improvements over previous attempts. The primary success factor was the use of InGeneron's technology for isolating the stem cells at point of care. In this regard, a recent publication by Winnier et al. (PLoS One 2019;14:e0221457) demonstrated that the technology used (TransposeRT / Matrase; InGeneron, Inc., Houston, TX, USA), provides the highest published number of living, uncultured, autologous, adult pluripotent stem cells recovered per gram of adipose tissue.

The second differentiator to all previously published results for myocardial regeneration is the application method to the damaged heart. Haenel et al. administered the stem cells retrograde through the hearts venous system, precisely to the area in need of regeneration. This retrograde injection technique, combined with a temporary blockage of the coronary vein at the level of a previous arterial occlusion, allowed the stem cells to overcome the endothelial barrier and thereby created a homogenous distribution of injected cells throughout the damaged myocardial tissue.

Dr. Eckhard Alt, Executive Chair of InGeneron, Inc. and senior author of the study, commented "this therapy, which may be performed in an ambulatory setting without the known risks associated with major anticoagulation, delivers the stem cells in about 15 minutes and involves a total treatment time of approximately 3 hours. This gives hope that millions of patients suffering from chronic ischemic heart failure might benefit from rebuilding the heart with their own stem cells".

The study, entitled "Unmodified autologous stem cells at point of care for chronic myocardial infarction", by Haenel et al. was published in the World Journal of Stem Cells on October 26, 2019.

While the company is advancing its ongoing clinical programs for key orthopedic conditions, additional studies are designed to validate the clinical potential of stem cells in patients with coronary artery disease and chronic heart failure.

About InGeneron

InGeneron is a clinical stage cell therapy company enabling novel, safe and evidence-based regenerative medicine therapies. Our purpose is to set new therapeutic standards by developing treatments that unlock the healing potential of each patients own regenerative cells processed at the point of care for same-day application. We focus on helping patients who are impacted by musculoskeletal indications and are pursuing research to extend the application of our platform technology to additional treatment areas.

http://www.ingeneron.com

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Global Cell Based Assay & High Content Screening Markets, 2020-2024 | Forecast by Application with Executive & Consultant Guides -…

By daniellenierenberg

DUBLIN--(BUSINESS WIRE)--The "Cell Based Assay & High Content Screening Markets Market Forecasts by Application, With Executive and Consultant Guides and including Customized Forecasting and Analysis 2020 to 2024" report has been added to ResearchAndMarkets.com's offering.

Cell Based Assays are a mainstay of drug development and scientific research, but growth is now accelerating as new immuno-oncology markets create unprecedented investment in the race to cure cancer. On top of this new technology is allowing Cell Based Assays to be used to measure any aspect of cell function. This market just keeps on growing with no end in sight. The workhorse of the pharmaceutical industry is becoming a central player in biotechnology.

This is a complex area but this readable report will bring the entire management team up to speed, on both the technology and the opportunity.

The technology is moving faster than the market. Genomics and Immunology are playing a role too. Find opportunities and pitfalls. Understand growth expectations and the ultimate potential market size.

Key Topics Covered

1. Introduction and Market Definition

1.1 What are Cell Based Assays?

1.2 Clinical Trial Failures

1.2.1 Immuno-oncology Plays a Leading Role in Cell Based Assays

1.3 Market Definition

1.3.1 Market Size

1.3.2 Currency

1.3.3 Years

1.4 Methodology

1.4.1 Authors

1.4.2 Sources

1.5 U.S. Medical Market and Pharmaceutical Research Spending - Perspective

1.5.1 U.S. Expenditures for Pharmaceutical Research

2. Cell Based Assays - Guide to Technology

2.1 Cell Cultures

2.1.1 Cell Lines

2.1.2 Primary Cells

2.1.3 Stem Cells

2.1.3.1 iPSC's - The Special Case

2.2 Cell Assays

2.3 Cell Viability Assays

2.3 Cell Proliferation Assays

2.4 Cytotoxicity Assays

2.5 Cell Senescence Assays

2.6 Apoptosis

2.7 Autophagy

2.8 Necrosis

2.9 Oxidative Stress

2.10 2D vs. 3D

2.11 Signalling Pathways, GPCR

2.12 Immune Regulation & Inhibition

2.13 Reporter Gene Technology

2.14 CBA Design & Development

2.15 Cell Based Assays - The Takeaway

3. Industry Overview

3.1 Players in a Dynamic Market

3.1.1 Academic Research Lab

3.1.2 Contract Research Organization

3.1.3 Genomic Instrumentation Supplier

3.1.5 Cell Line and Reagent Supplier

3.1.6 Pharmaceutical Company

3.1.7 Audit Body

3.1.8 Certification Body

4. Market Trends

4.1 Factors Driving Growth

4.1.1 Candidate Growth

4.1.2 Immuno-oncology

4.1.3 Genomic Blizzard

4.1.4 Technology Convergence

4.1.5 The Insurance Effect

4.2 Factors Limiting Growth

4.2.1 CBA Development Challenges

4.2.2 Instrument Integration

4.2.3 Protocols

4.3 Technology Development

4.3.1 3D Assays

4.3.2 Automation

4.3.3 Software

4.3.4 Primary Cells

4.3.5 Signalling and Reporter Genes

4.3.6 The Next Five Years

5. Cell Based Assays Recent Developments

5.1 Recent Developments - Importance and How to Use This Section

5.1.1 Importance of These Developments

5.1.2 How to Use This Section

6. Profiles of Key Cell Based Assay Companies

7. Global Market Size

7.1 Cell Based Assay Global Market Size by Region with Charts

7.2 Cell Based Assays Global Market Size by Type with Charts

8. Global Market by User Type

8.1 Pharmaceutical Market

8.1.1 Pharmaceutical Market by Region with Chart

8.2 Basic Research Market

8.2.1 Basic Research Market by Region with Chart

8.3 Industrial/Cosmetic Market

8.3.1 Industrial/Cosmetic Market by Region with Chart

9. Cell Based Assay by Product Class

9.1 Instrument Market

9.1.1 Instrument Market by Region with Chart

9.2 Reagent Market

9.2.1 Reagent Market by Region with Chart

9.3 Services Market

9.3.1 Services Market by Region with Chart

9.4 Software Market

9.4.1 Software Market by Region with Chart

10. Appendices

10.1 FDA Cancer Drug Approvals by Year

10.2 Clinical Trials Started 2010 to 2016

10.3 Share of Pharma R&D by Country

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/atsea9

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Global Cell Based Assay & High Content Screening Markets, 2020-2024 | Forecast by Application with Executive & Consultant Guides -...

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The Stars in Our Brains – Duke Department of Neurology

By daniellenierenberg

More than 10 million people worldwideabout 1 percent of people over age 60live with Parkinsons disease. There are treatments that can help control symptoms, but there is no cure.

The hallmark of the disease is the death of certain brain cellsneurons that produce dopamine. Most Parkinsons researchers have focused on studying these cells. But what if the disease starts elsewhere? What if it involves not only neurons but other cells that interact with neurons? In particular, what role is played by astrocytes, star-shaped cells that nurture and help form the connections, or synapses, between the neurons?

(This article by Angela Spivey, with photos by Alex Boerner, originally appeared in Duke Medical Alumni News. Read that story here.)

Thats the question a team of Duke researchers led by Cagla Eroglu, PhD, associate professor of cell biology and neurobiology, is exploring, thanks to a $1 million grant from the Chan Zuckerberg Initiative.

Sitting in her office, Eroglu picks up an orange plastic object that resembles a piece of coral, its tentacles branching this way and that. This is a model of a mouse astrocyte, she says. It can interact with 100,000 synapses at the same time. Astrocytes, she explains, infiltrate the brain, touching everything within their reach. They communicate with its synapses, regulating blood flow and metabolism.

Astrocytes from the Greek astron, meaning "star"have traditionally been thought of as support cells. But that thinking is changing. Since astrocytes are in such close contact and continuously communicating with synapses, we are beginning to appreciate that they are also fundamentally involved in regulating brain function, Eroglu says.

Collaborating with Albert La Spada, MD, PhD, Eroglu found that a certain gene known to be important in Parkinsons is more highly expressed in astrocytes than in neurons. And when the researchers mutated that gene in astrocytes, they saw some intriguing changes. This still-unpublished work laid the foundation for their proposal to the Chan Zuckerberg Initiative, which is bringing together experimental scientists from divergent fields to take a fresh look at the causes of neurodegenerative disorders.

There are vanishingly few papers that have delved into how astrocytes are contributing to the Parkinsons disease process, says La Spada, professor of neurology and vice chair of research for the Department of Neurology. This is an area that's been under-studied, and I think that the results that we're generating are suggesting that it deserves more attention.In addition to his long experience studying neurodegenerative diseases, La Spada brings expertise in growing astrocytes from induced pluripotent stem cells (IPSCs). That process starts by growing skin cells from a skin biopsy from a Parkinsons patient. Then we use what's called a reprogramming protocol to basically revert them to stem cells that are pluripotent. Once you create the IPSCs, you could use them to make any cell you wanta muscle cell or a cardiac cell or a neuron or an astrocyte, La Spada says. The beauty of this is, it comes from the patient who has the disease of interest."

His labs expertise will only grow because of the Chan Zuckerberg Initiative, which has formed focus groups for grantees around various areas, such as stem cell modeling, CRISPR gene-editing technology, bioinformatic analysis of data sets, and more. We're meeting other researchers from around the world who are doing really unique things. It's a chance for us all to compare notes, and I think this will accelerate all of our endeavors, La Spada says.

Rounding out the team is Nicole Calakos, MD, PhD, a scientist and clinician who treats patients with movement disorders, including Parkinsons. Calakos says that when she first met Eroglu, she was intrigued by her idea that since astrocytes are involved in sculpting the language of neurons, perhaps they play a role in the events that can lead to disease.

Everybody has been fixated like a magnet on the idea that the problem is the neuron that's dying, Calakos says. Cagla said, Hey, let's think outside of the box of that dead cell. Lets consider whether astrocytes are like the soil around a plant, providing the nutrition, and allowing it to form roots, and maybe that is whats broken. Why aren't we even thinking about this critical piece of the brain?

Eroglu puts it this way: Maybe the problem is loss of connections between neurons, even before they die.

Calakos says that part of the reason she came to Duke was the close intermingling of physicians and bench scientists. Because of how the community is at Duke, Cagla and I had been exchanging ideas and collaborating over the years, she says. The Chan Zuckerberg grant is an opportunity to get together as a formal team. I think it's really forward-thinking of them to have teams of basic scientists and practicing physicians all talking to each other.

The Chan Zuckerberg Initiative was launched in December 2015 by Mark Zuckerberg, founder and CEO of Facebook, and Priscilla Chan, a pediatrician and founder and CEO of The Primary School in East Palo Alto. In addition to her clinical insight, Calakos brings expertise in electrophysiologyreal-time recording and observation of electrical signals coming from brain cells. We can listen to the language of synapses, she says. They speak in electrical currents,which we can measure. Eroglu believes that by learning all they can about how astrocytes support synaptic development and health in the normal brain, they may find ways to stop neurodegenerative diseases like Parkinsons.

We are seeing aging as a part of development, Eroglu says. If your house is built on a strong base, then it might last longer. Whereas, if you build it in another way, it may be there for a while, but gradually start to break down.

This doesn't mean that we are destined to have neurodegeneration and we can't do anything. We may be more predisposed to get the disease, but we may not get it if we have done something else in our lives that helps strengthen our brain. I strongly believe that there will be ways to stop neurodegeneration.We will find a way to strengthen the brain connections. If we can figure out the weakest link, then we could concentrate on solving that.

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Michael Schumacher: Has the racing champ recovered? Stem Cell Therapy doctor unknowingly confirmed Schumi’s procedure? – EconoTimes

By daniellenierenberg

Michael Schumacher was said to have been admitted to a hospital in Paris the past September. Based on the news, he was transported to the medical facility by helicopter, and he was there to receive the procedure called Stem Cell Therapy.

According to The Telegraph, Schumachers latest treatment is giving his family and friends the big hope that his condition would improve. The treatment is one of the latest procedures that was developed to help people suffering from various illnesses. It uses stem cells to treat patients and help prevent disease or certain health conditions.

Did Schumi really try the Stem Cell Therapy for his condition?

Michael Schumachers health is a closely guarded matter so no knows exactly how he is doing after coming out of his coma more than five years ago. It can be recalled that he sustained a grave head injury after hitting a rock while skiing in the Alps in 2013.

Thus, it is not surprising if details of this alleged stem cell procedure are also being kept a secret by his family. They would not even confirm if he was really hospitalized for the treatment but a nurse supposedly said that Schumi is now conscious after the procedure. La Parisien via Mirror reported that an unnamed nurse claimed that the F1 legend showed signs of recovery.

"Yes he is in my service," she said. "And I can assure you that he is conscious."

Doctor may have confirmed the therapy

It was said that Dr. Philippe Menasche, a French cardiac surgeon, performed the procedure on Michael Schumacher and when the news broke out for the first time, he slammed the people who were alleging that his treatment on Schumi was only experimental.

As per Australias 7News, the doctor hit out the media for covering the treatment on Michael Schumacher and giving out false information. When the media called his advanced procedures experimental, he refuted the claims and said that he dont perform miracles.

"My team and I are not doing an experiment, an abominable term that is not in line with a serious medical view, he told the Italian newspaper La Republica. In any case, Menasch reaction was meant to defend his stem cell therapy treatment however, he seemed to have unknowingly confirmed that he treated Michael Schumacher as well.

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Regenerative Medicine Market Industry Outlook, Growth Prospects and Key Opportunities – Health News Office

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.

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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 are Vericel 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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Plant of the week: Plant thought to boost milk production now used for skin eruptions – Cyprus Mail

By daniellenierenberg

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BioRestorative Therapies Receives A Second Patent in Australia For Its Metabolic Program – Yahoo Finance

By daniellenierenberg

MELVILLE, N.Y., Oct. 23, 2019 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company") (BRTX), a life sciences company focused on stem cell-based therapies, today announced that the Australia Patent Office has issued a Certificate of Grant for the Companys patent application titled Human Brown Adipose Derived Stem Cells and Uses.

This is the second patent issued for the Companys brown fat technology in Australia and adds to three other patents related to BioRestoratives metabolic program (ThermoStem Program) that have previously been issued to the Company in the United States and other countries.

This patent will allow for the protection of a specific isolated human brown adipose tissue stem cell line capable of differentiating into multiple cell types. This particular cell line possesses strong characteristics applicable for potential therapeutic uses for treating a wide range of degenerative and metabolic disorders, including diabetes, hypertension, cardiac deficiency and obesity.

This patent, granted by the Australian Patent Office for our metabolic program, adds to our growing family of IP surrounding and protecting our brown fat metabolic cell program, said Mark Weinreb, CEO of BioRestorative Therapies. In particular, our invention relates to an isolated brown fat stem cell line that we expect to be used in our development of cell-based therapies to treat metabolic disorders.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

Metabolic Program (ThermoStem): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Story continues

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, whether the Company will be able to consummate the private placement and the satisfaction of closing conditions related to the private placement and those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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Hemostemix Announces Positive Results and Conclusions Reported in Phase II CLI Trial Abstract – Yahoo Finance

By daniellenierenberg

CALGARY, Alberta, Oct. 21, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (Hemostemix or the Company) (TSX VENTURE: HEM; OTCQB: HMTXF), a biotechnology company developing and commercializing blood-derived stem cell therapies for unmet medical conditions, is pleased to provide a summary of the presentation entitled Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup. Lead investigator Dr. York Hsiang, Professor of Vascular Surgery, University of British Columbia gave this update at the 41st Annual Canadian Society for Vascular Surgery Meeting on September 14, 2019.

Dr. Hsiang reported on the blinded results from the long-term follow-up of the first cohort of patients enrolled at two trial sites, Vancouver Coastal Health Research Institute (VCHRI) located in Vancouver, BC, led by principal investigator, Dr. York N. Hsiang, MB, ChB, MHSc, FRCSC and University Health Network, Peter Monk Cardiac Centre located in Toronto, Ontario, led by principal investigator Dr. Thomas Lindsay, MDCM, MSc, FRCSC, FACS.

Following is a summary of the results and conclusion:

In addition, the Companys Data Safety Monitoring Board (DSMB) recently met to review patient safety data in the ongoing Phase II clinical trial for CLI. The DSMB did not find safety concerns with ACP-01 and recommended continuing to enroll patients in the trial. The clinical trial is ongoing at 13 clinical sites in the US and Canada, with several additional sites in the process of being initiated. To date, 46 of the planned 95 patients have been enrolled and treated in the study.

We are very pleased with these blinded long term follow up results, and the recommendation of the DSMB, which are consistent with the findings reported in our two previous published studies of ACP-01 in CLI patients, said Dr. Alan Jacobs, President and Chief Medical Officer of Hemostemix. Patients with critical limb ischemia face a high rate of amputation when revascularization treatment options are exhausted, so seeing this level of improvement, and outcomes maintained for up to 4.5 years after treatment, is extremely encouraging.

ABOUT HEMOSTEMIX INC.

Hemostemix is a publicly traded clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is one of the first clinical-stage biotech companies to test a stem-cell therapy in an international, multicenter, Phase II clinical trial for patients with critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. The Phase II trial targets a participants diseased tissue with proprietary cells grown from his or her blood that can support the formation of new blood vessels. The Companys intellectual property portfolio includes over 50 patents issued or pending throughout the world. Hemostemix has a manufacturing contract with Aspire Health Science, LLC (Aspire), for the production of ACP-01 and for research and development purposes at Aspires Orlando, Florida, facility. Building towards commercialization, Hemostemix has also licensed the use, sale and import of ACP-01 for certain indications to Aspire in certain jurisdictions. The Company is continuing research and development of its lead product, ACP-01 with other applications, including cardiovascular, neurological and vascular indications.

For more information, please visit http://www.hemostemix.comor email office@hemostemix.com.

Contact:

Kyle Makofka, CEOSuite 2150, 300 5th Avenue S.W.Calgary, Alberta T2P 3C4Phone: (403) 506-3373E-Mail: kmakofka@hemostemix.com

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential, and similar expressions, or that events or conditions will, would, may, could, or should occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Companys stage of development, future clinical trial results, long-term capital requirements and future ability to fund operations, future developments in the Companys markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Companys operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.

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Hemostemix Announces Positive Results and Conclusions Reported in Phase II CLI Trial Abstract - Yahoo Finance

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Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 – PRNewswire

By daniellenierenberg

WHIPPANY, N.J., Oct. 21, 2019 /PRNewswire/ -- Bayer today announced recipients of the inaugural Pulmonary Hypertension Accelerated Bayer (PHAB) Awards, a U.S.-based research grant program created to support clinical research in pulmonary hypertension (PH), with a focus on pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The recipients will receive a combined total of $1 million in grants over a two-year period, making the PHAB Awards one of the largest industry-funded grant programs focused on PAH and CTEPH in the U.S. The eight award recipients were formally announced at a ceremony during the American College of Chest Physicians (CHEST) Annual Meeting in New Orleans on Sunday, October 20, 2019.

"Supporting a new generation of researchers is imperative to ensure we continue the progress that has been made during the past decade in pulmonary hypertension and its related conditions," said Aleksandra Vlajnic, M.D., Senior Vice President & Head Medical Affairs Americas at Bayer. "Our hope is that the PHAB Awards program will encourage researchers to think creatively about solving the significant treatment and patient care challenges that remain, knowing Bayer is committed to providing the support needed to help bring those ideas to fruition. We want to congratulate all of the applicants on their winning proposals."

The recipients are:

The PHAB Awards recipients were selected by an independent Grants Review Committee, consisting of the following eminent PH leaders:

"I would like to thank and recognize the Grants Review Committee for their time and commitment, and the PH community in the U.S. for their overwhelming response to the inaugural PHAB Awards," said Sameer Bansilal, M.D., M.S., Medical Director, U.S. Medical Affairs at Bayer. "We look forward to an even greater response next year and encourage eligible applicants to start thinking about submitting their research proposals."

The PHAB Award eligibility, review and category criteria were modeled after the National Institutes of Health (NIH) system; entries were graded on significance, investigator(s), innovation, approach, and environment.

For more information on the PHAB Awards visit: https://www.phab-awards.com/awards/or e-mail PHAB.awards@bayer.com.

Grants were made on the merits of the research, and research must be posted on ClinicalTrials.gov. Every effort should be made to publish or present study outcomes. If the research is not conducted the grant must be returned.

About Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH, WHO Group 1) is defined by elevated pressure in the arteries going from the right side of the heart to the lungs. Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope. PAH is caused by abnormalities in the walls of the pulmonary arteries.1,2

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Chronic Thromboembolic Pulmonary Hypertension (CTEPH, WHO Group 4) is a progressive type of pulmonary hypertension, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart.3,4 CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard and potentially curative treatment for CTEPH is pulmonary thromboendarterectomy (PTE), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material.5,6 However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35 percent of patients, the disease persists or reoccurs after PTE.7

About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to http://www.bayer.us.

Our online press service is just a click away: http://www.bayer.us/en/newsroomFollow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on Twitter: https://twitter.com/Bayerus

Media Contact:David Patti, +1-973-452-6793Bayer, U.S. Product Communications david.patti@bayer.com

Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:1Galie et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart. 2016;37:67119.2American Lung Association. Pulmonary Hypertension. Accessed November 22, 2017. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/pulmonary-hypertension.3Piazza G and Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011; 364: 351-360.4 Simonneau G et al. Updated Clinical Classification of Pulmonary Hypertension. Journal of the American College of Cardiology. 2013; 62(25):5 D'Armini M. Diagnostic advances and opportunities in chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015; 24: 253262.6 Kim et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013; 62: D92-9.7 Mathai et al. Quality of life in patients with chronic thromboembolic pulmonary hypertension. Eur Respir J. 2016 Aug; 48(2): 526537.

SOURCE Bayer

http://www.bayer.us

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Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 - PRNewswire

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Best Growth Report On Autologous Stem Cell Based Therapies Market Survey 2019 Industry Outlines, Future Trends, Forecasts And Regional Segmented…

By daniellenierenberg

Crystal Market Research has recently announced Latest Innovative Report on Global Autologous Stem Cell Based Therapies Market 2025 gives an exact assessment of authentic and current market size, share, income, request, generation, utilization (worth and volume), and market improvement as well as reliable estimations up to 2025. It likewise examines Autologous Stem Cell Based Therapies Market scope, potential, benefit, and attractiveness which significantly studies Industry execution at a moment level. Besides, it reveals insight into competition segmentation, environment and leading organizations that are considered as a portion of the significant features of the market.

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This Autologous Stem Cell Based Therapies Market study offers a synopsis of the Industry on a global level that helps users in the decision-making processes, which helps to boost their businesses. An exhaustive investigation of the competitive framework of the worldwide Autologous Stem Cell Based Therapies Market has been given, introducing insights into the organization profiles, financial status, ongoing advancements and the SWOT examination.

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Best Growth Report On Autologous Stem Cell Based Therapies Market Survey 2019 Industry Outlines, Future Trends, Forecasts And Regional Segmented...

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Hemostemix Announces Positive Results and Conclusions Reported in Phase II CLI Trial Abstract – GlobeNewswire

By daniellenierenberg

CALGARY, Alberta, Oct. 21, 2019 (GLOBE NEWSWIRE) -- Hemostemix Inc. (Hemostemix or the Company) (TSX VENTURE: HEM; OTCQB: HMTXF), a biotechnology company developing and commercializing blood-derived stem cell therapies for unmet medical conditions, is pleased to provide a summary of the presentation entitled Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup. Lead investigator Dr. York Hsiang, Professor of Vascular Surgery, University of British Columbia gave this update at the 41st Annual Canadian Society for Vascular Surgery Meeting on September 14, 2019.

Dr. Hsiang reported on the blinded results from the long-term follow-up of the first cohort of patients enrolled at two trial sites, Vancouver Coastal Health Research Institute (VCHRI) located in Vancouver, BC, led by principal investigator, Dr. York N. Hsiang, MB, ChB, MHSc, FRCSC and University Health Network, Peter Monk Cardiac Centre located in Toronto, Ontario, led by principal investigator Dr. Thomas Lindsay, MDCM, MSc, FRCSC, FACS.

Following is a summary of the results and conclusion:

In addition, the Companys Data Safety Monitoring Board (DSMB) recently met to review patient safety data in the ongoing Phase II clinical trial for CLI. The DSMB did not find safety concerns with ACP-01 and recommended continuing to enroll patients in the trial. The clinical trial is ongoing at 13 clinical sites in the US and Canada, with several additional sites in the process of being initiated. To date, 46 of the planned 95 patients have been enrolled and treated in the study.

We are very pleased with these blinded long term follow up results, and the recommendation of the DSMB, which are consistent with the findings reported in our two previous published studies of ACP-01 in CLI patients, said Dr. Alan Jacobs, President and Chief Medical Officer of Hemostemix. Patients with critical limb ischemia face a high rate of amputation when revascularization treatment options are exhausted, so seeing this level of improvement, and outcomes maintained for up to 4.5 years after treatment, is extremely encouraging.

ABOUT HEMOSTEMIX INC.

Hemostemix is a publicly traded clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is one of the first clinical-stage biotech companies to test a stem-cell therapy in an international, multicenter, Phase II clinical trial for patients with critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. The Phase II trial targets a participants diseased tissue with proprietary cells grown from his or her blood that can support the formation of new blood vessels. The Companys intellectual property portfolio includes over 50 patents issued or pending throughout the world. Hemostemix has a manufacturing contract with Aspire Health Science, LLC (Aspire), for the production of ACP-01 and for research and development purposes at Aspires Orlando, Florida, facility. Building towards commercialization, Hemostemix has also licensed the use, sale and import of ACP-01 for certain indications to Aspire in certain jurisdictions. The Company is continuing research and development of its lead product, ACP-01 with other applications, including cardiovascular, neurological and vascular indications.

For more information, please visit http://www.hemostemix.comor email office@hemostemix.com.

Contact:

Kyle Makofka, CEOSuite 2150, 300 5th Avenue S.W.Calgary, Alberta T2P 3C4Phone: (403) 506-3373E-Mail: kmakofka@hemostemix.com

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential, and similar expressions, or that events or conditions will, would, may, could, or should occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Companys stage of development, future clinical trial results, long-term capital requirements and future ability to fund operations, future developments in the Companys markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Companys operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.

Read this article:
Hemostemix Announces Positive Results and Conclusions Reported in Phase II CLI Trial Abstract - GlobeNewswire

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Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 – BioSpace

By daniellenierenberg

WHIPPANY, N.J., Oct. 21, 2019 /PRNewswire/ -- Bayer today announced recipients of the inaugural Pulmonary Hypertension Accelerated Bayer (PHAB) Awards, a U.S.-based research grant program created to support clinical research in pulmonary hypertension (PH), with a focus on pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The recipients will receive a combined total of $1 million in grants over a two-year period, making the PHAB Awards one of the largest industry-funded grant programs focused on PAH and CTEPH in the U.S. The eight award recipients were formally announced at a ceremony during the American College of Chest Physicians (CHEST) Annual Meeting in New Orleans on Sunday, October 20, 2019.

"Supporting a new generation of researchers is imperative to ensure we continue the progress that has been made during the past decade in pulmonary hypertension and its related conditions," said Aleksandra Vlajnic, M.D., Senior Vice President & Head Medical Affairs Americas at Bayer. "Our hope is that the PHAB Awards program will encourage researchers to think creatively about solving the significant treatment and patient care challenges that remain, knowing Bayer is committed to providing the support needed to help bring those ideas to fruition. We want to congratulate all of the applicants on their winning proposals."

The recipients are:

The PHAB Awards recipients were selected by an independent Grants Review Committee, consisting of the following eminent PH leaders:

"I would like to thank and recognize the Grants Review Committee for their time and commitment, and the PH community in the U.S. for their overwhelming response to the inaugural PHAB Awards," said Sameer Bansilal, M.D., M.S., Medical Director, U.S. Medical Affairs at Bayer. "We look forward to an even greater response next year and encourage eligible applicants to start thinking about submitting their research proposals."

The PHAB Award eligibility, review and category criteria were modeled after the National Institutes of Health (NIH) system; entries were graded on significance, investigator(s), innovation, approach, and environment.

For more information on the PHAB Awards visit: https://www.phab-awards.com/awards/or e-mail PHAB.awards@bayer.com.

Grants were made on the merits of the research, and research must be posted on ClinicalTrials.gov. Every effort should be made to publish or present study outcomes. If the research is not conducted the grant must be returned.

About Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH, WHO Group 1) is defined by elevated pressure in the arteries going from the right side of the heart to the lungs. Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope. PAH is caused by abnormalities in the walls of the pulmonary arteries.1,2

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Chronic Thromboembolic Pulmonary Hypertension (CTEPH, WHO Group 4) is a progressive type of pulmonary hypertension, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart.3,4 CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard and potentially curative treatment for CTEPH is pulmonary thromboendarterectomy (PTE), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material.5,6 However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35 percent of patients, the disease persists or reoccurs after PTE.7

About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to http://www.bayer.us.

Our online press service is just a click away: http://www.bayer.us/en/newsroomFollow us on Facebook: http://www.facebook.com/pharma.bayerFollow us on Twitter: https://twitter.com/Bayerus

Media Contact:David Patti, +1-973-452-6793Bayer, U.S. Product Communicationsdavid.patti@bayer.com

Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:1Galie et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart. 2016;37:67119.2American Lung Association. Pulmonary Hypertension. Accessed November 22, 2017. http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/pulmonary-hypertension.3Piazza G and Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011; 364: 351-360.4 Simonneau G et al. Updated Clinical Classification of Pulmonary Hypertension. Journal of the American College of Cardiology. 2013; 62(25):5 D'Armini M. Diagnostic advances and opportunities in chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015; 24: 253262.6 Kim et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013; 62: D92-9.7 Mathai et al. Quality of life in patients with chronic thromboembolic pulmonary hypertension. Eur Respir J. 2016 Aug; 48(2): 526537.

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Drug Treats Inflammation Related to Genetic Heart Disease – Technology Networks

By daniellenierenberg

When young athletes experiences sudden cardiac death as they run down the playing field, it's usually due to arrhythmogenic cardiomyopathy (ACM), an inherited heart disease. Now, Johns Hopkins researchers have shed new light on the role of the immune system in the progression of ACM and, in the process, discovered a new drug that might help prevent ACM disease symptoms and progression to heart failure in some patients.

"We realized that heart muscle inflammation in ACM is much more complicated than we thought, but also might provide a therapeutic strategy," saysStephen Chelko, Ph.D., assistant professor of medicine at the Johns Hopkins University School of Medicine and senior author of the new paper, inSept. inCirculation.

In ACM, patients often harbor mutations in any of the five genes that make up the cardiac desmosome -- the gluelike material that holds heart cells together and helps coordinate mechanical and electrical synchronization of heart cells. Because of this, it's often called "a disease of the cardiac desmosome." In patients with ACM, heart cells pull apart over time, and these cells are replaced with damaged and inflamed scar tissue. These scars can increase risk of instances of irregular heart rhythms and lead to sudden cardiac death if the scar tissue causes the heart wall to stiffen and renders it unable to pump.

If a person is aware they carry an ACM-causing genetic mutation, doctors help them avoid cardiac death through lifestyle changes, such as exercise restriction, and medications that keep their heart rate low. However, there are currently no drugs that treat the underlying structural defects of the desmosome. People who live for many years with ACM still accumulate scar tissue and inflammation in their hearts, leading to chronic heart disease.

"We tended in the past to view ACM as something that kills due to a sudden arrhythmic event," said Chelko. "But now we're starting to also see it as a chronic inflammatory disease that can progress more slowly over time, leading to heart failure."

Chelko and his colleagues wanted to determine the molecular cause of inflammation in the hearts of people with ACM. So they studied mice with an ACM-causing mutation, as well as heart muscle cells generated from stem cells isolated from an ACM patient. They found that the inflammation associated with the disease arose from two separate causes. First, they noticed high levels of macrophages, a type of immune cell that's normally found at sites of inflammation, such as around cuts or scrapes that are healing.

"Macrophages are usually the good guys who help heal a wound and then leave," said Chelko. "But in ACM they're permanently setting up shop in the heart, which, over time, reduces its function."

Chelko's team also found that in ACM, the heart cells themselves are triggered by a protein known as nuclear factor kappa-light-chain-enhancer of activated B cells (NF-B) to produce chemicals called cytokines, which act as homing beacons for other inflammatory cells and molecules. When the researchers treated mice or isolated cells with a drug blocking NF-B, heart cells stopped producing many of these cytokines, leading to decreased inflammation and infiltration of inflammatory cells. In mouse models of ACM, animals treated with the NF-B-blocking drug Bay-11-7082 had a twofold increase in heart function, measured by how much blood their hearts could pump over time compared with untreated ACM animals. They also had a twofold reduction of damaged and inflammatory scar tissue in the heart.

More than one-third of patients with ACM who die of sudden cardiac death have no previous cardiac symptoms, so wouldn't ever know to seek treatment. However, for relatives of these people who discover that they carry a genetic mutation causing ACM -- or those who discover the mutation for other reasons -- a drug could help stave off long-term heart disease, Chelko said.

While the Bay-11-7082 drug is currently only used in the lab for experimental purposes, the U.S. Food and Drug Administration has approved canakinumab, a drug that targets the same inflammatory pathway, for use in juvenile arthritis and a collection of rare auto-inflammatory syndromes. Canakinumab is also being studied for use in coronary artery disease. Chelko's group is now investigating whether this drug would have the same effect as Bay-11-7082 in ACM.

"We're very excited to have found an FDA-approved drug that can reduce heart inflammation in ACM, and we're eager to do more research to ultimately help those who carry these genetic mutations," said Chelko.

Reference:Chelko, et al. (2019) Therapeutic Modulation of the Immune Response in Arrhythmogenic Cardiomyopathy. Circulation. DOI:https://doi.org/10.1161/CIRCULATIONAHA.119.040676

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Analysis on Worldwide Autologous Stem Cell Based Therapies Market Inclinations Exhibit Growing Demand During The Period Until 2025 – Wheel Chronicle

By daniellenierenberg

Crystal Market Research recently offers Exclusive Profitable Report on Global Autologous Stem Cell Based Therapies Market Provides valuable supply of perceptive information for business strategists of Industry Outlook Sizing with Competitive Landscape By 2025

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Analysis on Worldwide Autologous Stem Cell Based Therapies Market Inclinations Exhibit Growing Demand During The Period Until 2025 - Wheel Chronicle

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Sphingosine 1-phosphate: Lipid signaling in pathology and therapy – Science Magazine

By daniellenierenberg

Mediating systemic health

Sphingosine 1-phosphate (S1P) is an important circulating lipid mediator that is derived from the metabolism of cell membranes. Its diverse homeostatic roles, particularly in immunology and vascular biology, can go awry in numerous diseases, including multiple sclerosis, cardiovascular diseases, and fibrosis. The centrality of S1P signaling has led to the development of several drugs, including two approved for treatment of multiple sclerosis. In a Review, Cartier and Hla discuss the current understanding of how one mediator can carry out so many signaling roles in different tissues, how these become dysregulated in disease, and efforts in drug development to target S1P signaling.

Science, this issue p. eaar5551

Sphingosine 1-phosphate (S1P), a product of membrane sphingolipid metabolism, is secreted and acts through G proteincoupled S1P receptors (S1PRs) in vertebrates. S1PR isoforms mediate complex cellular actions either alone or in combination in most organ systems. This stable lysolipid circulates as a complex with protein chaperones that not only enables aqueous solubility but also helps facilitate specific modes of receptor signaling. However, differential concentration gradients of S1P are normally present in various compartments and are perturbed under disease conditions. The abundance of circulatory S1P and the high expression of S1PRs in exposed cellsthat is, vascular and hematopoietic cellsposes a key question of how this signaling axis is regulated. This question is of clinical relevance because the first S1PR-targeted drug, fingolimod, has been approved for the treatment of multiple sclerosis since 2010. Recent findings from basic research as well as insights gleaned from clinical and translational studies have enriched our understanding of how this simple lysolipid evolved as a complex regulator of multiple physiological systems and, when dysregulated, contributes to numerous diseases.

Extracellular spatial gradients of S1P, demonstrated by using S1P reporters, are tightly regulated and control fundamental processes such as hematopoietic cell trafficking, immune cell fate, and vascular integrity. The gradients are formed through location-specific function of metabolic enzymes, S1P transporters, and chaperones. Such physiological S1P gradients are altered in diseases, thus contributing to conditions such as inflammation, autoimmunity, and vascular dysfunction. S1P complexed to chaperone proteinsfor example, high-density lipoproteinbound apolipoprotein Mmediate distinct modes of receptor activation, resulting in biased receptor signaling and specific biological outcomes. S1PRs are also regulated tightly through endocytic mechanisms and receptor modulators that enhance or inhibit signal strength and duration. Various signaling mechanisms of this simple lysolipid mediator has helped reveal its multiple actions in the immune system, which include adaptive immune cell localization in various compartments (egress versus retention), fate switching, survival, and activation that influences both cell-mediated and humoral immunity. In the cardiovascular system, high expression of multiple S1PR isoforms in various cell types regulate development, homeostasis, and physiology. Current S1PR-targeted drugs that aim to tame autoimmunity exhibit considerable cardiovascular-adverse events. In the central nervous system (CNS), widespread application of S1PR-targeted drugs in autoimmune neuroinflammatory diseases has stimulated research that revealed the broad but poorly understood effects of S1P signaling in neurodevelopment, the neurovascular unit, neurons, and glia. Furthermore, in addition to the involvement of pathological S1P signaling in acute ischemic conditions of various organs, chronic dysregulated S1P signaling has been implicated in fibrotic diseases of lung, heart, liver, and kidney.

Considerable challenges remain to fully harness the new knowledge in S1P pathobiology to translational utility in clinical medicine. Approaches that mimic S1P chaperones, S1P neutralizing agents, modulation of transporters, biased agonists and antagonists of S1PR isotypes, and sphingolipid metabolic enzyme modulators provide viable pathways to therapy. Focusing on the immune system, such approaches may widen the autoimmunity therapeutic landscape and provide new directions in cancer and chronic inflammatory diseases. For cardiovascular diseases, ischemic conditions as well as chronic heart failure are likely candidates for future translational efforts. Although further work is needed, S1P-targeted approaches may also be useful in regenerative therapies for the aging and diseased myocardium. The CNS-targeted efforts may cross into neurodegenerative diseases, given the success with S1PR-targeted drugs in reducing brain atrophy in multiple sclerosis. Other potential applications include approaches in pain management and neurodevelopmental disorders. Such strategies, although challenging, are greatly helped by findings from basic research on S1P pathobiology as well as pharmacological and clinical insights derived from the application of S1P-targeted therapeutics.

Extracellular S1P gradients created by transporters, chaperones (ApoM+HDL), and metabolic enzymes (LPP3) interact with S1PRs on the cell surface. Receptor activity, transmitted by means of G proteins, is regulated by multiple mechanisms, including -arrestin coupling, endocytosis, and receptor modulators. The resultant cellular changes influence multiple organ systems in physiology and disease.

Sphingosine 1-phosphate (S1P), a metabolic product of cell membrane sphingolipids, is bound to extracellular chaperones, is enriched in circulatory fluids, and binds to G proteincoupled S1P receptors (S1PRs) to regulate embryonic development, postnatal organ function, and disease. S1PRs regulate essential processes such as adaptive immune cell trafficking, vascular development, and homeostasis. Moreover, S1PR signaling is a driver of multiple diseases. The past decade has witnessed an exponential growth in this field, in part because of multidisciplinary research focused on this lipid mediator and the application of S1PR-targeted drugs in clinical medicine. This has revealed fundamental principles of lysophospholipid mediator signaling that not only clarify the complex and wide ranging actions of S1P but also guide the development of therapeutics and translational directions in immunological, cardiovascular, neurological, inflammatory, and fibrotic diseases.

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Research Roundup: Genomic Dark Matter Mutation and More – BioSpace

By daniellenierenberg

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

Mutation Found in Dark Matter of the Genome New Target for Cancer

The so-called dark matter of the genome is the non-coding regions that make up about 98% of the genome. Researchers at the Ontario Institute for Cancer Research (OICR) recently identified a novel cancer-driven mutation in this region that is linked to brain, liver and blood cancer. They published the two studies in the journal Nature.

Non-coding DNA, which makes up 98% of the genome, is notoriously difficult to study and is often overlooked since it does not code for proteins, said Lincoln Stein, co-lead of the two research studies and Head of Adaptive Oncology at OICR. By carefully analyzing these regions, we have discovered a change in one letter of the DNA code that can drive multiple types of cancer. In turn, weve found a new cancer mechanism that we can target to tackle the disease.

The mutation is dubbed U1-snRNA, and it appears to disrupt normal RNA splicing, which changes the transcription of genes that drive cancer. The mutation was identified in tumors of patients with specific subtypes of brain cancer and was found in almost all of the samples. The cancer was sonic hedgehog medulloblastoma. It was also found in samples of chronic lymphocytic leukemia (CLL) and hepatocellular carcinoma.

Our unexpected discovery uncovered an entirely new way to target these cancers that are tremendously difficult to treat and have high mortality rates, said Michael Taylor, pediatric neurosurgeon and senior scientist in Development and Stem Cell Biology and Garron Family Chair in in Childhood Cancer Research at The Hospital for Sick Children and co-lead of the studies. Weve found that with one typo in the DNA code, the resultant cancers have hundreds of mutant proteins that we might be able to target using currently available immunotherapies.

Diagnosing Lyme Disease in 15 Minutes

About 300,000 people are diagnosed with Lyme disease each year. Borrelia burgdorferi is transmitted by the bite of infected Ixodes ticks, and if untreated, can cause neurologic, cardiac, and rheumatologic complications. Current testing involves two complex tests, ELISA and western blot. Researchers have developed a rapid microfluidic test that can provide comparable results in as little as 15 minutes. It will require more refinement and testing before widespread use.

Gene Therapy for Wet Age-Related Macular Degeneration Shows Promise

Research was recently presented on six patients who received a gene therapy for wet age-related macular degeneration (AMD). The patients have gone at least six months without continued injections for the disease that were previously required every four to six weeks. The therapy, which is injected into the eye, generates a molecule much like aflibercept, a broadly used anti-VEGF drug.

How Dementia Spreads Throughout Brain Networks

Frontotemporal dementia (FDT) is similar to Alzheimers disease, but tends to hit patients earlier and affects different parts of the brain. Researchers studied how well neural network maps made from brain scans in healthy people could predict the spread of brain atrophy in FTD patients over several years. They recruited 42 patients at the UCSF Memory and Aging Center with a form of FTD and 30 with another form. They received MRI scans and then follow-up scans a year later to determine how the disease had progressed. They found that the standardized connectivity maps were able to predict the spread of the disease.

Mucus and Microbes: A Therapeutic Gold Mine.

A specific type of molecule called glycans that are found in mucus prevent bacteria from communicating with each other. Mucus also prevents the bacteria from forming infectious biofilms. It is also pointed out that more than 200 square meters of our bodies are lined with mucus. There are hundreds of different types of glycans found in mucus, and most of them are responsible for suppressing bacteria. Katharina Ribbeck, a professor at the Massachusetts Institute of Technology, says, What we have in mucus is a therapeutic gold mine.

Mechanisms that Regulate Brain Inflammation

The role of brain inflammation in diseases like Alzheimers and Parkinsons is becoming better understood. Researchers recently identified mechanisms that regulate brain inflammation, which has the potential to open new avenues for treating and preventing these diseases. The scientists found that a protein called TET2 modulates the immune response in microglia, immune cells in the brain, during inflammation. In mice engineered not to have TET2 in the microglia, neuroinflammation is reduced. Normally, TET2 with other proteins regulates the activity of genes by removing specific chemical markers from DNA, but TET2 appears to behave differently in microglia.

Pilot Study: Even Short-Term Vaping Causes Lung Inflammation

Research out of The Ohio State University Comprehensive Cancer Center found cellular inflammation was caused by e-cigarette, i.e., vaping, use in both long-term smokers and people who did not smoke. They used bronchoscopy to evaluate for inflammation and smoking-related effects and found a measurable increase in inflammation after only four weeks of vaping without nicotine or flavors. The amount of inflammation was small compared to the control group, but the data suggests that even short-term use can result in inflammatory changes at a cellular level. Inflammation in smoking is a driver of lung cancer and other respiratory diseases.

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SIDS May Be Linked To A Genetic Inability To Digest Milk, Study Finds – Moms

By daniellenierenberg

Sudden Infant Death Syndrome (SIDS), sometimes known as crib death, occurs when an infant under the age of one dies inexplicably.The typically healthy child will often die while sleeping and is the leading cause of death of children between the ages of one month and one year, claiming approximately 3000 lives a year. There has been little known about the cause of SIDS but new research is now showing that some form of SIDS could be linked to a genetic inability to digest milk.

A study out of theUniversity of Washington School of Medicine focused on the "mitochondrial tri-functional protein deficiency, a potentially fatal cardiac metabolic disorder caused by a genetic mutation in the gene HADHA."

It found that newborns with had the genetic mutation are unable toproperly digest some of the fats found in breastmilk, resulting in cardiac arrest. It found that "the heart cells of affected infants do not convert fats into nutrients properly," and once these fats build up they can cause serious heart and heart health issues.

There are multiple causes for sudden infant death syndrome, said Hannele Ruohola-Baker, who is also associate director of the UW Medicine Institute for Stem Cell and Regenerative Medicine. There are some causes which are environmental. But what were studying here is really a genetic cause of SIDS. In this particular case, it involves a defect in the enzyme that breaks down fat.

Lead author on the study Dr. Jason Miklassaid that it was his experience researching heart disease that prompted him to look at the possible link with SIDS. There was one particular study that had noted a link between children who had problems processing fats and who also had cardiac disease that caused him to delve a little deeper.

Miklas andRuohola-Baker teamed up to begin their own research study.If a child has a mutation, depending on the mutation the first few months of life can be very scary as the child may die suddenly,Miklas noted. An autopsy wouldnt necessarily pick up why the child passed but we think it might be due to the infants heart-stopping to beat.

Were no longer just trying to treat the symptoms of the disease, Miklas added. Were trying to find ways to treat the root problem. Its very gratifying to see that we can make real progress in the lab toward interventions that could one day make their way to the clinic.

Ruohola-Baker says their findings are a big breakthrough in understanding SIDS. There is no cure for this, she said. But there is now hope because weve found a new aspect of this disease that will innovate generations of novel small molecules and designed proteins, which might help these patients in the future.

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Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable…

By daniellenierenberg

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of two regimens of KEYTRUDA, Mercks anti-PD-1 therapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is recommended in patients whose tumors express PD-L1 (combined positive score [CPS] 1). This recommendation is based on data from the pivotal Phase 3 KEYNOTE-048 trial, in which KEYTRUDA, as monotherapy and in combination with chemotherapy, demonstrated a significant improvement in overall survival, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), in these patient populations.

Head and neck cancer remains a devastating disease with poor long-term outcomes and advances in survival have been difficult to achieve for more than 10 years said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. The positive EU CHMP opinion further validates the potential of KEYTRUDA, as monotherapy and in combination with chemotherapy, to help patients and address the high unmet need in this aggressive form of head and neck cancer.

Merck currently has the largest immuno-oncology clinical development program in HNSCC and is continuing to advance multiple registration-enabling studies investigating KEYTRUDA as monotherapy and in combination with other cancer treatmentsincluding, KEYNOTE-412 and KEYNOTE-689. The CHMPs recommendation will now be reviewed by the European Commission for marketing authorization in the EU, and a final decision is expected in the fourth quarter of 2019.

About Head and Neck CancerHead and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck. Two substances that greatly increase the risk of developing head and neck cancer are tobacco and alcohol. It is estimated that there were more than 705,000 new cases of head and neck cancer diagnosed and over 358,000 deaths from the disease worldwide in 2018. In Europe, it is estimated that there were more than 146,000 newly diagnosed cases of head and neck cancer and around 66,000 deaths from the disease in 2018.

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

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 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 patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

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

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 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 patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

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

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

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

Classical Hodgkin LymphomaKEYTRUDA 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 LymphomaKEYTRUDA 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 the treatment of patients with PMBCL who require urgent cytoreductive therapy.

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

Microsatellite Instability-High (MSI-H) CancerKEYTRUDA 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 CancerKEYTRUDA 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 CancerKEYTRUDA 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 CancerKEYTRUDA 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 CarcinomaKEYTRUDA 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 CarcinomaKEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. 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 CarcinomaKEYTRUDA, 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 PneumonitisKEYTRUDA 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 Grade 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 ColitisKEYTRUDA 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 HepatitisKEYTRUDA 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 AxitinibKEYTRUDA 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 EndocrinopathiesKEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. 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 hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 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 DysfunctionKEYTRUDA 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 ReactionsImmune-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 ReactionsImmune-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 cHL, 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 ReactionsKEYTRUDA 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 MyelomaIn 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 ToxicityBased 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 ReactionsIn KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

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

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

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

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; 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%).

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 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%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent of which (1%) included hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%). The most common adverse reactions (>1%) resulting in permanent discontinuation of KEYTRUDA, axitinib or the combination were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). When KEYTRUDA was used in combination with axitinib, the most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

LactationBecause of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the final dose.

Pediatric UseThere is limited experience in pediatric patients. In a trial, 40 pediatric patients (16 children aged 2 years to younger than 12 years and 24 adolescents aged 12 years to 18 years) with various cancers, including unapproved usages, were administered KEYTRUDA 2 mg/kg every 3 weeks. Patients received KEYTRUDA for a median of 3 doses (range 117 doses), with 34 patients (85%) receiving 2 doses or more. The safety profile in these pediatric patients was similar to that seen in adults; adverse reactions that occurred at a higher rate (15% difference) in these patients when compared to adults under 65 years of age were fatigue (45%), vomiting (38%), abdominal pain (28%), increased transaminases (28%), and hyponatremia (18%).

Mercks Focus on CancerOur goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit http://www.merck.com/clinicaltrials.

About MerckFor more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimers disease and infectious diseases including HIV and Ebola. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USAThis news release of Merck & Co., Inc., Kenilworth, N.J., USA (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2018 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

Please see Prescribing Information for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf andMedication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

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Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable...

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6 Bodily Tissues That Can Be Regenerated Through Nutrition – The Epoch Times

By daniellenierenberg

Spontaneous recovery from disease is often painted as superstition but our body can heal itself

It may come as a surprise to some, especially those with conventional medical training, but the default state of the body is one of ceaselessregeneration. Without the flame-like process of continual cell turnover within the bodylife and death ceaselessly intertwinedthe miracle of the human body would not exist

In times of illness, however, regenerative processes are overcome by degenerative ones. This is where medicine may perform its most noble feat, nudging the body back into balance with foods, herbs, nutrients, and healing energies and intentions.

Today, however, drug-based medicine invariably uses chemicals that lackregenerative potential; to the contrary, they commonly interfere with bodily self-renewal in order to suppress the symptoms against which they are applied.

In other words, most medicines attack disease symptoms rather than support the bodys own ability to combat disease.

Over the course of the past few years of trolling MEDLINE (the National Institutes of Healths website produced by the National Library of Medicine), we have collected a series of remarkable studies on a topic considered all but heretical by the conventional medical systemspontaneous remission.

There is actually a broad range of natural compounds with proven nerve-regenerative effects. A 2010 study published in the journalRejuvenation Research, for instance, found a combination of blueberry, green tea and carnosine have neuritogenic (i.e. promoting neuronal regeneration) and stem-cell regenerative effects in an animal model ofneurodegenerative disease.Other researched neuritogenic substances include:

There is another class of nerve-healing substances, known asremyelinatingcompounds, which stimulate the repair of the protective sheath around the axon of the neurons known as myelin. Myelin is often damaged in neurological injury and/or dysfunction, especially autoimmune and vaccine-induceddemyelination disorders.

It should also be noted that evenmusicandfalling in lovehave been studied for possibly stimulating neurogenesis, regeneration and/or repair of neurons, indicating that regenerative medicine does not necessarily require the ingestion of anything; rather, a wide range oftherapeutic actionsmay be employed to improve health and well-being, as well.

[To view the first-hand biomedical citations on these neuritogenic substances, visit GreenMedinfosneuritogenicresearch page online.]

Glycyrrhizin, a compound found within licorice that is also a powerfulanti-SARS virus agent, has also been found to stimulate the regeneration of liver mass and function in the animal model of hepatectomy. Other liver regenerative substances include:

[To view the first-hand biomedical citations, visit GreenMedinfosliver regenerationresearch page on the topic online.]

The medical community has yet to harness the diabetes-reversing potential of natural compounds. Whereas expensive stem cell therapies, islet cell transplants, and an array of synthetic drugs in the developmental pipeline are the focus of billions of dollars of research, annually, our kitchen cupboards and backyards may already contain the long sought-after cure for type 1 diabetes. Nature has a way of providing the things our bodies need.

The following compounds have been demonstrated experimentally to regenerate the insulin-producing beta cells, which are destroyed in insulin-dependent diabetes, and once restored, may (at least in theory) restore the health of the patient to the point where they no longer require insulin replacement.

[To view the first-hand biomedical citations onbeta cell regeneration, visit GreenMedinfos research page on the topic online.]

Secretagogues are substances in the body that cause other substances to be secreted, like sulfonylureas, which triggers insulinrelease. Secretagogues, includingsynthetic secretagogues, can increase the endocrine glands ability to secrete more of a hormone. But even better are substances thattruly regeneratehormones which have degraded. They do this by emitting electrons into potentially carcinogenic transient hormone metabolites. One of these substances isvitamin C.

A powerful electron donor, this vitamin has the ability to contribute electrons to resurrect the form and function of estradiol (estrogen; E2), progesterone, and testosterone, for instance. In tandem withfoods that are able to support the function of glandslikethe ovaries, vitamin C may represent an excellent complement or alternative to hormone replacement therapy.

Not too long ago, it was believed that cardiac tissue was uniquely incapable of being regenerated. A new and rapidly growing body of experimental research now indicates that this is simply untrue. A class of heart-tissue regenerating compounds, known asneocardiogenicsubstances, are able to stimulate the formation of cardiac progenitor cells which can differentiate into healthy heart tissue. Neocardiogenicsubstances include the following:

Another remarkable example of cardiac cell regeneration is through what is known as the fetomaternal trafficking of stem cells through the placenta. The amazing process known as fetal microchimerism allows a fetus to contribute stem cells to the mother which are capable of regenerating her damaged heart cells, and possibly a wide range of other cell types.

Curcuminandresveratrolhave been shown to improve recovery from spinal cord injury. Over a dozen other natural compounds hold promise in this area, which can be viewed on GreenMedinfosspinal cord injurypage online. As far as degenerative joint disease, i.e. osteoarthritis, there are a broad range of potentially regenerative substances, with 50 listed on the sitesosteoarthritisresearch page.

Regenerative medicine poses a unique challenge to the current medical paradigm, which is based on costly drug trials, patents, and an economic infrastructure supported by drug-based interventions. It is a simple truth that symptom suppression is profitable. It guarantees both the perpetuation of the original underlying disease and the generation of an ever-expanding array of additional, treatment-induced symptoms known as side effects.

But cures, especially those that come from natural sources, dont have this built-in income potential. Worse perhaps, from a Big Pharma perspective, they can not be easily patented. In the current regulatory environment, that means that companies have no incentive to conduct the costly trials required to have these cures approved by the FDA and then used in clinical settings. Without patents, they cant be controlled and sold.

But suppressing symptoms with drugs that cause side effects requiring other drugs is a non-sustainable, infinite growth model. It is doomed to fail and eventually collapse.

The current approach also interferes with the bodys natural regenerative and immune capabilities. Cultivating diets, lifestyles and attitudes conducive to bodily regeneration can interrupt this pathological circuit. With true health, we can attain the bodily freedom that is a precondition for the liberation of the human spirit.

SayerJiis the founder ofGreenmedinfo.com, a reviewer at theInternational Journal of Human Nutrition and Functional Medicine, co-founder and CEO ofSystome Biomed, vice chairman of the board of theNational Health Federation, and steering committee member of theGlobal GMO Free Coalition.This article was originally published on GreenMedinfo.com

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6 Bodily Tissues That Can Be Regenerated Through Nutrition - The Epoch Times

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Reviewing Cellular Biomedicine Group Inc. (CBMG)’s and VistaGen Therapeutics Inc. (NASDAQ:VTGN)’s results – MS Wkly

By daniellenierenberg

We are contrasting Cellular Biomedicine Group Inc. (NASDAQ:CBMG) and VistaGen Therapeutics Inc. (NASDAQ:VTGN) on their institutional ownership, profitability, risk, analyst recommendations, dividends, earnings and valuation. They both are Biotechnology companies, competing one another.

Valuation and Earnings

Table 1 showcases the gross revenue, earnings per share and valuation of Cellular Biomedicine Group Inc. and VistaGen Therapeutics Inc.

Profitability

Table 2 hightlights the return on equity, return on assets and net margins of the two companies.

Volatility & Risk

Cellular Biomedicine Group Inc. is 167.00% more volatile than Standard & Poors 500 because the company has a beta of 2.67. In other hand, VistaGen Therapeutics Inc. has beta of -0.48 which is 148.00% less volatile than Standard & Poors 500.

Liquidity

Cellular Biomedicine Group Inc. has a Current Ratio of 4.4 and a Quick Ratio of 4.4. Competitively, VistaGen Therapeutics Inc.s Current Ratio is 4.9 and has 4.9 Quick Ratio. VistaGen Therapeutics Inc.s better ability to pay short and long-term obligations than Cellular Biomedicine Group Inc.

Analyst Ratings

The table given features the ratings and recommendations for Cellular Biomedicine Group Inc. and VistaGen Therapeutics Inc.

Cellular Biomedicine Group Inc. has a 55.30% upside potential and an average target price of $23. Competitively VistaGen Therapeutics Inc. has an average target price of $22, with potential upside of 1,592.31%. The results from earlier shows that analysts opinion suggest that VistaGen Therapeutics Inc. seems more appealing than Cellular Biomedicine Group Inc.

Institutional & Insider Ownership

Institutional investors held 23.8% of Cellular Biomedicine Group Inc. shares and 20.4% of VistaGen Therapeutics Inc. shares. Insiders held roughly 37.14% of Cellular Biomedicine Group Inc.s shares. Competitively, insiders own roughly 0.2% of VistaGen Therapeutics Inc.s shares.

Performance

Here are the Weekly, Monthly, Quarterly, Half Yearly, Yearly and YTD Performance of both pretenders.

For the past year Cellular Biomedicine Group Inc. has stronger performance than VistaGen Therapeutics Inc.

Summary

On 6 of the 11 factors VistaGen Therapeutics Inc. beats Cellular Biomedicine Group Inc.

Cellular Biomedicine Group Inc., a biopharmaceutical company, develops treatments for cancerous and degenerative diseases in Greater China. It focuses on developing and marketing cell-based therapies to treat serious diseases, such as cancer, orthopedic, and various inflammatory diseases, as well as metabolic diseases. The company develops treatments utilizing proprietary cell based technologies, including immune cell therapy for the treatment of a range of cancers; human adipose-derived mesenchymal progenitor cells for the treatment of joint and autoimmune diseases; and tumor cell specific dendritic cell therapy. The company has a strategic research collaboration with GE Healthcare Life Sciences China to co-develop industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing. Cellular Biomedicine Group Inc. was incorporated in 2001 and is headquartered in Cupertino, California.

VistaGen Therapeutics, Inc., a clinical-stage biopharmaceutical company, engages in developing and commercializing medicines for depression and other central nervous system (CNS) disorders. The company's lead product candidate is AV-101, which is in Phase II development stage, an adjunctive treatment used for major depressive disorder. It also focuses on potential commercial applications of its human pluripotent stem cell (hPSC) technology platform to discover, rescue, develop, and commercialize new chemical entities (NCEs) for CNS and other diseases; and regenerative medicine involving hPSC-derived blood, cartilage, heart, and liver cells. In addition, the company develops CardioSafe 3D, an in vitro cardiac bioassay system for predicting human heart toxicity of small molecule NCEs. VistaGen Therapeutics, Inc. has licensing, sublicensing, and collaboration agreements with BlueRock Therapeutics, LP; U.S. National Institutes of Health; Cato Research Ltd.; and University Health Network. The company was founded in 1998 and is headquartered in South San Francisco, California.

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Reviewing Cellular Biomedicine Group Inc. (CBMG)'s and VistaGen Therapeutics Inc. (NASDAQ:VTGN)'s results - MS Wkly

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