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 reduced ejection fraction (HFrEF) were presented as a
late breaking presentation at the American Heart Association (AHA)
annual Scientific Sessions during a featured program 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, presented new results from the landmark study
showing a significant relationship between presence of systemic
inflammation as quantified by high-sensitivity C-reactive protein
(hs-CRP) and treatment benefit with rexlemestrocel-L on risk of
cardiovascular mortality, heart attacks or strokes.
In a release by the American Heart Association, Dr. Perin said:
“Cell therapy has the potential to change how we treat heart
failure. This study addresses the inflammatory aspects of heart
failure, which go mostly untreated, despite significant
pharmaceutical and device therapy development.”
Key findings of pre-specified outcomes were:
- A single dose of rexlemestrocel-L on
top of standard of care reduced the incidence of heart attacks or
strokes by 65% across all 537 NYHA class II or class III treated
patients compared with standard of care alone, p=0.0011
- Across 301 NYHA class II and class
III treated patients with high levels of inflammation (hs-CRP ≥
2mg/L), rexlemestrocel-L reduced the incidence of heart attacks or
strokes by 79% compared with standard of care alone,
p<0.0011
- In NYHA class II patients with high
levels of inflammation (hs-CRP ≥ 2mg/L), a single dose of
rexlemestrocel-L reduced the incidence of cardiovascular death by
80% compared with standard of care alone, p=0.0051
- Compared with standard of care
alone, a single dose of rexlemestrocel-L on top of standard of care
reduced the incidence of cardiovascular death, heart attacks or
strokes by 33% across all 537 NYHA class II or class III patients,
p=0.021, and by 45% in the 301 patients with high levels of
inflammation (hs-CRP ≥ 2mg/L), p=0.0121
- Compared with standard of care alone, addition of
rexlemestrocel-L did not further reduce the frequency of
hospitalization for worsening HF symptoms as previously
reported
In a release from Texas Heart Institute, President & CEO Dr.
Joseph G. Rogers said that the Texas Heart Institute prides itself
upon consistently striving to uncover The Next First in
cardiovascular discovery and treatment.
Whereas most traditional treatments address the congestion or
fluid overload associated with heart failure, rexlemestrocel-L
addresses the inflammation that is at the centre of advanced
chronic heart failure – widely regarded as the leading cause of
death in the developed world.
The ability of rexlemestrocel-L to significantly impact cardiac
death, heart attacks and strokes on top of maximal HFrEF therapy
reflects the unique mechanisms-of-action of this allogeneic
cellular therapy on reduction of inflammation and improved
microvasculature. The unchecked intra-cardiac inflammation in HFrEF
patients causes progressive loss of heart muscle, replacement with
scar tissue, and death. Persistent inflammation in the blood
circulation also results in accelerated atherosclerosis with plaque
progression and instability resulting in plaque rupture and
potential blockage of major arteries, resulting in high rates of
heart attacks and strokes in chronic HFrEF patients.
Rexlemestrocel-L reduces inflammatory cytokine production by
immune cells, generating improved local networks of blood vessels
within the damaged heart and reducing risk of plaque rupture in
major arteries. The observed relationship between systemic
inflammation and degree of benefit from treatment with
rexlemestrocel-L supports the importance of the anti-inflammatory
mechanism-of-action of rexlemestrocel-L in addressing the high-risk
of mortality and morbidity in HFrEF patients.
In addition to Dr. Perin, the DREAM-HF study co-authors are Drs
Barry Greenberg, MD, Kenneth Borow, MD, Timothy Henry, MD, Farrell
Mendelsohn, MD, Les Miller, MD, Elizabeth Swiggum, MD, Eric Adler,
MD, Christopher James, PA, and Silviu Itescu, MD. The study’s
findings have been submitted for publication.
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.2-4
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.
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 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
- All p-values are descriptive and not adjusted for
multiplicity
- 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
- Virani SS, Alonso A, Benjamin EJ, et al. American Heart
Association Council on Epidemiology and Prevention Statistics
Committee and Stroke Statistics Subcommittee. Heart Disease and
Stroke Statistics - 2020 update: a report from the American Heart
Association.Circulation 2020;141:e139-e596.
Forward-Looking StatementsThis 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 actual
results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. All statements other than statements of historical
fact, including our intention to discuss a regulatory pathway with
the FDA, are forward-looking statements, which are often indicated
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“expect,” “goal,” “intend,” “likely,” “look forward to,” “may,”
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“would” and similar expressions and variations thereof. We make
such forward-looking statements pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and other federal securities laws. Forward-looking statements
should not be read as a guarantee of future performance or results,
and actual results may differ from the results anticipated in these
forward-looking statements, and the differences may be material and
adverse. The risks, uncertainties and other factors that may impact
our forward-looking statements include, but are not limited to: the
timing, progress and results of Mesoblast’s preclinical and
clinical studies; Mesoblast’s ability to advance product candidates
into, enroll and successfully complete, clinical studies; the
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Mesoblast’s ability to establish and maintain intellectual property
on its product candidates and Mesoblast’s ability to successfully
defend these in cases of alleged infringement. You should read this
press release together with our risk factors, in our most recently
filed reports with the SEC or on our website. Uncertainties and
risks that may cause Mesoblast’s actual results, performance or
achievements to be materially different from those which may be
expressed or implied by such statements, and accordingly, you
should not place undue reliance on these forward-looking
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statements, whether as a result of new information, future
developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul Hughes |
Grant Titmus |
T: +61 3 9639 6036 |
T: +61 419 388 161 |
E: investors@mesoblast.com |
E: grant@sumitmedia.com.au |
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Alex Davis-Isaac |
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E:
adavisisaac@rubenstein.com |
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