Mesoblast Limited: Is Stemcell Therapy Ready For Prime Time? – Sick Economics

Mesoblast, MESO, is an Australian based biopharmaceutical company that has been a market favorite, even though the companys ups and downs have confused many investors.

The MESO share price has been inconsistent lately. This has prompted many investors to ask why. Analyzed carefully, MESO has done better than many stem cell businesses. Most stem cell businesses fail to ever make a profit and fail to even get a product to market. This can cause long-term problems with the stock price of any company.

ByMichael A. Mannen, MS

Mesoblast as a company is committed to offering groundbreaking cellular therapies for the treatment of many severe diseases using Mesenchymal Stem Cells. They are dedicated to cellular medicines and leveraging their stem cell technology. There are not many successful companies in this niche.

Adult stem cells are undifferentiated cells that divide and rebuild the damaged tissue. Mesenchymal Stem Cells are a type of adult stem cells generated from some of the adult tissues present in the body.

Stem cells have been found by scientists to have two properties: self-renewal and the potential to divide into specialized cell types. Multi-potent, mesenchymal stem cells are found to be present in many adult tissues. The bone marrow is considered by many scientists to be the most usable reservoir of adult human stem cells.

For several disorders, such as heart failure, the capacity to rebuild tissue may be groundbreaking for treatment. And this has been the inspiration for many companies exploring stem cell therapies.

However, what differentiates Mesoblast from other stem cell companies is its approach to treating inflammatory diseases. Their products have the potential to make breakthroughs a reality for many diseases.

The company has developed and manufactured its own patented mesenchymal lineage cells to be used for a range of ailments. These have a potential for the regeneration of tissues. These cells, however, secrete a number of biomolecules which can help the body heal more than just tissue damage. They may be important to supporting immune responses needed for recovery in many diseases.

Possible rejection of the patients immune system is the biggest problem with the use of stem cell therapies in heart diseases and other diseases. This can worsen many illnesses.

MESO does appear committed to the quality of its product. For MESO it is a question of the effectiveness and safety of their products. Its a long and winding road to provide adequate scientific proof when presenting breakthrough treatments to regulators. Many less reputable organizations have touted stem cells without doing the necessary scientific investigation or seeking the necessary regulatory approval. Mesoblast is trying to do things the right way. Committing to doing science the right way leads to a lot of inevitable ups and downs. This raises financial speculation and can lead to wild fluctuations in the stock price of any company.

A further significant advantage of some of Mesoblasts products is that they apparently can be administered to patients without needing donor matching. This increases their viability. Moreover, it allows for a wide spectrum of patients to be treated from their products. This gives them an advantage in comparison with other firms and should potentially allow them to increasingly gain a larger market share.

Of great interest to investors include the many clinical trial phase 3 products that Mesoblast has in its pipeline. These include MPC-06-ID, Remestemcel-L, and REVASCOR.

Remestemcel-L is a Mesoblast therapy that may theoretically have properties to help with the treatment of ventilator-dependent patients with COVID-19 patients. However, a clinical trial reported some concerns with the therapy meeting its primary endpoint. And it sent the stock down in December 2020. Obviously, there is a large demand for the treatment of complications linked to Covid-19, so this bad news disappointed investors.

However, another therapy has shown promise in the DREAM-HF Phase 3 for patients with chronic heart failure. Although the Revasacor did not stop heart failure, it did seem to deliver dramatic reductions in heart attacks and other negative cardiovascular events that plague heart failure patients.

Heart failure is a pathology that involves ones heart having trouble pumping. The condition impacts millions of people worldwide. In order to feed and maintain it working, the heart muscle depends on a continuous supply of oxygen rich blood. Having stem cell therapies is highly desirable to treat cardiovascular diseases. Hopefully, many Cardiovascular disorders can be treated with stem cell therapies in the future.

Other conditions such as hypertension and Coronary artery disease can help lead to heart failure. According to the Mayo Clinic, heart failure can cause significant health complications and lead to Liver and Kidney damage in patients.

Some scientists believe that Mesenchymal Stem Cells when used to treat cardiovascular diseases can preserve the myocardium by reducing the intensity of inflammation and supporting angiogenesis. Angiogenesis is a mechanism used by the body to create new blood vessels. Their low immunogenicity once more makes them a perfect treatment. This helps ensure that the immune system of the patient does not produce a negative response to the therapy. This theoretically can give stem cell therapies an advantage over some protein-based treatments that are easily recognized by the patients immune system.

This product could be a major development for Mesoblast moving forward, although further analysis and testing is still needed.

Stem cell therapies are not without experimental and medical challenges. For example, there are concerns with the ability of stem cell migration to tissues that require regeneration. There may also be cases whereby stem cells are divided into unintended cells. There may also be difficulties with the manufacturing and culturing of stem cells. Identification of Mesenchymal stem cells in cell populations can be problematic. From a scientific point of view, bone marrow derived Mesenchymal Stem Cells are known to be the best source for obtaining these cells in the human body.

Mesoblast has a wide range of advanced research programs related to different stem cell therapies. MPC-06-ID could potentially be a viable therapy for treating chronic low back pain attributable to degenerative disc disease.

These are products that consumers should be thrilled about.

The company has solid financials for a stem cell company and has a lot of cash on hand. The stock had a market cap of over 2 billion on 9/30/2020 and a 52-week high of 21.28. Lately the news surrounding the companys clinical trials has been a potpourri of both good and bad, so the share price has settled at around $9. It has a float of 93.7 million shares.

Mesoblast is a really exciting healthcare business. The business has made a commitment for the future. And it should be a stock that investors continue to follow.

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Mesoblast Limited: Is Stemcell Therapy Ready For Prime Time? - Sick Economics

Caladrius Biosciences Treats First Patient in the Phase 2b FREEDOM Trial of CLBS16 for the Treatment of Coronary Microvascular Dysfunction | DNA RNA…

Details Category: DNA RNA and Cells Published on Wednesday, 20 January 2021 10:45 Hits: 402

Initiation of the Phase 2b FREEDOM trial represents the next step in development of CLBS16 as a potential breakthrough treatment for the millions of sufferers of CMD in the U.S., most of whom are women

Patient enrollment underway at The Christ Hospital Health Network in Cincinnati (OH) and Mayo Clinic in Rochester (MN) with additional sites across the United States targeted to open soon

Strong investigator and subject interest driven by the positive results of the Phase 2a ESCaPE-CMD trial reported in spring of 2020

BASKING RIDGE, NJ, USA I January 19, 2021 I Caladrius Biosciences, Inc. (Nasdaq: CLBS) (Caladrius or the Company), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, announced that it has treated the first patient in its Phase 2b FREEDOM trial of CLBS16 as a therapy for coronary microvascular dysfunction (CMD) at The Christ Hospital Health Network in Cincinnati, Ohio. The 105-patient double-blind and placebo-controlled clinical trial is designed to further evaluate the efficacy and safety of intracoronary delivery of autologous CD34+ cells (CLBS16) in subjects with CMD and without obstructive coronary artery disease.

We are very excited about our CLBS16 program as it represents a potential breakthrough in the treatment of CMD, a condition which afflicts millions of patients in the US alone, many of whom are women. As a result, CMD is a womens health issue of emerging importance as currently there are no products with approved labeling for coronary microvascular dysfunction, said David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. The treatment of the first patient in the FREEDOM trial is an important milestone for our Company and the program and we look forward to completing enrollment by the target of year-end 2021. It is especially noteworthy that even during the COVID-19 pandemic, physicians and patients are active in our trial, denoting the seriousness of the disease and underscoring the lack of available effective treatment for CMD.

Following the outstanding full data results from the ESCaPE-CMD study that I presented at SCAI 2020, we are very excited to participate in the FREEDOM trial, said Timothy D. Henry, M.D., Medical Director of the Carl and Edyth Lindner Center for Research at The Christ Hospital Health Network. Caladrius CLBS16 program has demonstrated great promise and I am looking forward to seeing how this new therapeutic option can benefit patients with CMD.

For more information on this study, please visit clinicaltrials.gov (identifier: NCT04614467).

If you are a patient or a physician and have questions about eligibility for this study, please visit http://www.freedom-trial.com.

About Coronary Microvascular Dysfunction

Coronary microvascular dysfunction is a type of non-obstructive coronary artery disease that causes decreased blood flow to the heart muscle that affects approximately 8.3 million people in the U.S.1,2 With common symptoms that include recurring, debilitating chest pain, tiredness, and shortness of breath, many CMD patients are undiagnosed because of the absence of large vessel obstruction. Due to an under appreciation of the disease, patients, the majority of whom are women, often go years without proper treatment. When a diagnosis of CMD is missed, patients are untreated and remain at high risk of heart attack and/or cardiovascular-related death. _______________________ [1] Mittal, S.R.; Indian Heart Journal, Volume 66, 2014, Pages 678681 [2] Cleveland Clinic/AHA (American Heart Association)

About Caladrius Biosciences Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. We are developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The Companys current product candidates include: HONEDRA (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (CLI) based on the results of an ongoing clinical trial; OLOGO (formerly CLBS14), a Regenerative Medicine Advanced Therapy (RMAT) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the FDA) a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (NORDA); CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study in the U.S. for the treatment of coronary microvascular dysfunction (CMD); CLBS119, an emergent CD34+ stem cell therapy responding to the COVID-19 pandemic and the potentially permanent damage the virus inflicts on the lungs of many patients; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for chronic kidney disease (CKD). For more information on the company, please visitwww.caladrius.com.

SOURCE: Caladrius Biosciences

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Caladrius Biosciences Treats First Patient in the Phase 2b FREEDOM Trial of CLBS16 for the Treatment of Coronary Microvascular Dysfunction | DNA RNA...