CLINICAL OUTCOMES OF MESOBLAST’S CELL THERAPY IN END-STAGE ISCHEMIC HEART FAILURE PRESENTED AT AMERICAN COLLEGE OF CARDIOLO...
March 30 2020 - 6:00AM
Results from a sub-study of 70 patients with end-stage ischemic
heart failure and a Left Ventricular Assist Device (LVAD), of 159
randomized patients who received either Mesoblast’s allogeneic
mesenchymal precursor cell (MPC) product candidate Revascor® or
saline, were presented on March 28 at the American College of
Cardiology (ACC) Virtual Scientific Sessions. The full results from
these 70 patients will be published in a peer-reviewed journal.
When compared to controls, in MPC recipients:
- the mean proportion of temporary weans from LVAD support was
higher (64% vs 43%; relative risk (RR) 1.55; 95% confidence
interval (CI) 1.01-2.36)
- the rate of mucosal bleeding was lower (4.2 vs 28/100
patient-months; RR 0.15; CI 0.05, 0.40)
- there were fewer serious adverse events (66.06 vs 120.35/100
patient-months; RR 0.55; CI 0.31,0.97)
- there were fewer readmissions (0.59 vs. 1.14/100 patient-days;
RR 0.52; CI 0.28, 0.95).
The conclusions were:
- MPCs had a beneficial effect on LVAD weaning, major mucosal
bleeding, serious adverse events, and readmissions in ischemic
heart failure patients
- these findings may reflect the effect of MPCs on angiogenesis,
inflammation and endothelial dysfunction, and warrant further
clinical research.
End-stage ischemic heart failure patients with
LVADs are older and have co-morbidities such as diabetes, thereby
closely resembling the majority of patients in Mesoblast’s
566-patient Phase 3 trial for advanced chronic heart failure,
planned to readout in mid-2020.
Revascor is being developed for use in end-stage
ischemic heart failure patients with LVADs under existing FDA
Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug
Designations. About
Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is
a world leader in developing allogeneic (off-the-shelf) cellular
medicines. The Company has leveraged its proprietary mesenchymal
lineage cell therapy technology platform to establish a broad
portfolio of commercial products and late-stage product candidates.
Mesoblast’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 filed a Biologics License Application to the United States
Food and Drug Administration (FDA) to seek approval of its
product candidate RYONCIL™ (remestemcel-L) for steroid-refractory
acute graft versus host disease (acute GvHD). Remestemcel-L is also
being developed for other rare diseases. Mesoblast is completing
Phase 3 trials for its product candidates for advanced heart
failure and chronic low back pain. If approved, RYONCIL is expected
to be launched in the United States in 2020 for pediatric
steroid-refractory acute GVHD. 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 a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 in all major markets. This IP position is
expected to provide the Company with substantial commercial
advantages as it develops its product candidates for these
conditions.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
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 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. 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. Forward-looking
statements include, but are not limited to, statements about 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
timing or likelihood of regulatory filings and approvals; and the
pricing and reimbursement of Mesoblast’s product candidates, if
approved. 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 statements. We do not undertake any obligations to
publicly update or revise any forward-looking statements, whether
as a result of new information, future developments or
otherwise.
Release authorized by the Chief Executive.
For further information, please contact:
Julie Meldrum |
Schond Greenway |
Corporate Communications |
Investor Relations |
T: +61 3 9639 6036 |
T: +1 212 880 2060 |
E: julie.meldrum@mesoblast.com |
E: schond.greenway@mesoblast.com |
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