Home Cellular science Rexlemestrocel-L Phase 3 Chronic Heart Failure Trial Results Selected for Last Minute...

Rexlemestrocel-L Phase 3 Chronic Heart Failure Trial Results Selected for Last Minute Presentation at American Heart Association Annual Meeting

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NEW YORK, Oct 06, 2021 (GLOBE NEWSWIRE) – Mesoblast Limited (Nasdaq: MESO; ASX: MSB), a world leader in allogeneic cellular drugs for inflammatory diseases, today announced the results of the randomized controlled trial phase 3 rexlemestrocel -L in 565 chronic heart failure (CHF) class II and New York Heart Association (NYHA) class III patients with low ejection fraction (HFrEF) were screened for peer review as a last minute presentation to the American Heart Association (AHA) annual meeting on November 13e– 15e. The featured session is titled “Building on Treatment Foundations: Advances in Heart Failure Treatment”.

The co-principal investigator of the trial, Dr. Emerson Perin, medical director of the Texas Heart Institute and clinical professor at Baylor College of Medicine, will make the presentation entitled “Randomized trial of targeted transendocardial administration of mesenchymal precursor cells in high-risk chronic heart failure patients with reduced ejection fraction ”. The session will also present late-breaking results from two additional heart failure trials with SGLT-2 inhibitors.

Last minute science sessions are innovative and provide the latest advancements in clinical science. These sessions provide notable exposure and recognition for studies that have the potential to have a significant impact on clinical practice and / or to make significant advances in a scientific field.

About chronic heart failure
Heart failure affects an estimated 6.5 million people in the United States and 26 million people worldwide, with increasing prevalence and incidence. The mortality rate approaches 50% at 5 years as patients progress beyond NYHA class II disease, along with increased intracardiac and systemic inflammation.1.2

Despite recent approvals of new therapies for HFrEF, including SGLT2 inhibitors, which have reduced hospitalizations due to reversible volume events, NYHA class II / III HFrEF patients with inflammation remain at high risk of heart death, heart attack and stroke. Rexlemestrocel is being developed as an immunomodulatory therapy to treat the high degree of intracardiac and systemic inflammation in chronic heart failure to reduce the high rate of major cardiac events (MACE) in these patients.

About the American Heart Association (AHA)
The American Heart Association is the oldest and largest voluntary organization in the United States dedicated to the fight against heart disease and stroke. Its scientific journals include Circulation, Stroke, and American Heart Association Journal (JAHA). The AHA Scientific Sessions are considered the most prestigious cardiovascular meeting in the world and have been held since 1925. The conference attracts over 15,000 attendees, the majority of whom are physicians and other cardiology professionals.

About the mesoblast
Mesoblast is a world leader in the development of allogeneic (ready-to-use) cellular drugs for the treatment of serious and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late stage product candidates that respond to severe inflammation by releasing anti-inflammatory factors that counteract and modulate multiple effector arms. of the immune system, resulting in a significant reduction in the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending to at least 2041 in all major markets. The Company’s proprietary manufacturing processes produce cryopreserved and ready-to-use cellular drugs on an industrial scale. These cell therapies, with defined pharmaceutical release criteria, should be readily available to patients around the world.

Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults, including acute steroid refractory graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products were marketed in Japan and Europe by the licensees of Mesoblast, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast is present in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Footnotes

  1. 2017 AHA Heart Disease and Stroke Statistics

  2. Ponikowski P., et al. Heart Failure: Preventing Illness and Death Worldwide. European Society of Cardiology. 2014 ; 1: 4-25

Forward-looking statements
This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or actual achievements differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact, including our intention to discuss a regulatory path with the FDA, are forward-looking statements, which are often indicated by words such as “anticipate”, “believe”, “could “,” Estimate, “,” “would” and similar expressions and variations thereof. We make such forward-looking statements in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be construed as a guarantee of future performance or results, and actual results may differ from the results anticipated in such forward-looking statements, and the differences may be material and adverse. Risks, uncertainties and other factors that may affect our forward-looking statements include, but are not limited to: the timing, progress and results of the pre-clinical and clinical studies of Mesoblast; Mesoblast’s ability to advance product candidates, enroll and complete clinical studies; the timing or likelihood of regulatory filings and approvals; whether the FDA accepts a regulatory path; and pricing and reimbursement of Mesoblast product candidates, if approved; Mesoblast’s ability to establish and maintain intellectual property in its product candidates and Mesoblast’s ability to successfully defend them in cases of suspected infringement. You should read this press release, along with our risk factors, in our latest reports filed with the SEC or on our website. The uncertainties and risks which may cause Mesoblast’s actual results, performance or achievements to differ materially from those which may be expressed or implied by such statements, and therefore, you should not place undue reliance on such statements prospective. Except as required by law, we assume no obligation to publicly update or revise forward-looking statements, whether as a result of new information, future developments, or otherwise.

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