Rexlemestrocel-L Phase 3 Trial Results in Chronic Heart Failure Selected as Late Breaking Presentation at American Heart Association Annual Meeting
October 06 2021 - 8:38PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced that results from the randomized, controlled Phase 3
trial of rexlemestrocel-L in 565 patients with New York Heart
Association (NYHA) class II and class III chronic heart failure
(CHF) with low ejection fraction (HFrEF) have been selected through
peer review as a late breaking presentation at the American Heart
Association (AHA) annual meeting occurring November 13th- 15th. The
featured session is titled ‘Building on the Foundations of
Treatment: Advances in Heart Failure Therapy’.
The trial’s co-principal investigator Dr Emerson Perin, Medical
Director of Texas Heart Institute, and Clinical Professor, Baylor
College of Medicine, will give the presentation titled ‘Randomized
Trial of Targeted Transendocardial Delivery of Mesenchymal
Precursor Cells in High-Risk Chronic Heart Failure Patients with
Reduced Ejection Fraction’. The session will also feature late
breaking results from two additional heart failure trials with
SGLT-2 Inhibitors.
Late-Breaking Science sessions are innovative and provide the
latest breakthroughs in clinical science. These sessions provide
notable exposure and recognition for studies likely 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 approximately 6.5 million people in the US and 26 million
people globally, with increasing prevalence and incidence. The
mortality rate approaches 50% at 5 years as patients progress
beyond NYHA class II disease in parallel with increasing
intra-cardiac and systemic inflammation.1,2
Despite recent approvals of new therapies for HFrEF, including
SGLT2 inhibitors, that have reduced hospitalizations due to
reversible volume-related events, NYHA class II/III HFrEF patients
with inflammation remain at high risk for cardiac death, heart
attacks and strokes. Rexlemestrocel is being developed as an
immunomodulatory therapy to address the high degree of
intra-cardiac and systemic inflammation in chronic heart failure in
order 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 US’s oldest and largest voluntary
organization dedicated to fighting heart disease and stroke. Its
scientific journals include Circulation, Stroke, and Journal of the
American Heart Association (JAHA). The AHA’s Scientific Sessions is
regarded as the world’s most prestigious cardiovascular meeting and
has been running since 1925. The conference attracts more than
15,000 attendees, with the majority being physicians and other
cardiology professionals.
About Mesoblast Mesoblast is a world leader in
developing allogeneic (off-the-shelf) cellular medicines for the
treatment of severe 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 which respond to severe inflammation
by releasing anti-inflammatory factors that counter and modulate
multiple effector arms of the immune system, resulting in
significant reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual
property portfolio with protection extending through to at least
2041 in all major markets. The Company’s proprietary manufacturing
processes yield industrial-scale, cryopreserved, off-the-shelf,
cellular medicines. These cell therapies, with defined
pharmaceutical release criteria, are planned to be readily
available to patients worldwide.
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 steroid refractory acute graft versus
host disease and moderate to severe acute respiratory distress
syndrome. Two products have been commercialized in Japan and Europe
by Mesoblast’s licensees, and the Company has established
commercial partnerships in Europe and China for certain Phase 3
assets.
Mesoblast has locations 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
- AHA’s 2017 Heart Disease and Stroke Statistics
- Ponikowski P., et al. Heart Failure: Preventing disease and
death worldwide. European Society of Cardiology. 2014; 1: 4-25
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Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul Hughes |
Sumit Media |
T: +61 3 9639 6036 |
Grant Titmus |
E: investors@mesoblast.com |
T: +61 419 388 161 |
|
E: grant@sumitmedia.com.au |
|
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|
Kristen Bothwell |
|
T: +1 917 613 5434 |
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E: kbothwell@rubenstein.com |
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