Data Monitoring Committee Completes Final Scheduled Review of Mesoblast’s Phase 3 Trial of Revascor in Advanced Chronic Hea...
December 18 2019 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) announced today that the
independent Data Monitoring Committee (DMC) overseeing the Phase 3
trial of Revascor for advanced chronic heart failure has held
its tenth and final scheduled meeting, and has recommended
that the trial continue as planned. This cardiovascular outcomes
trial has now initiated final study visits for all surviving
patients with a target of last patient/last visit at the end of
January 2020.The DMC reviewed available data from the 566
randomized patients, including components of the trial’s primary
and secondary endpoints, and all safety data. The results from this
pivotal trial are expected to be read out by mid-2020.
About
MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a
world leader in developing allogeneic (off-the-shelf) cellular
medicines. The Company has leveraged its proprietary cell therapy
technology platform to establish a broad portfolio of commercial
products and late-stage product candidates. Two products have been
commercialized in Japan and Europe by its licensees, and it has
established commercial partnerships in Europe and China for certain
Phase 3 assets. In the United States, Mesoblast has initiated
submission of a rolling Biologics License Application to the FDA to
seek approval of its product candidate for acute graft versus host
disease following a successful Phase 3 trial, and is completing
Phase 3 trials for its advanced heart failure and chronic low back
pain product candidates. Mesoblast’s proprietary manufacturing
process yields industrial-scale, frozen, off-the-shelf, cellular
medicines based on its mesenchymal lineage cell platform
technology. These cell therapies, with defined pharmaceutical
release criteria, are planned to be readily available to patients
worldwide. Mesoblast has locations in Melbourne, New York,
Singapore and Texas 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
Mesoblast’s 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. 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 authorised by the Chief Executive.
For further information, please contact:
Julie
Meldrum Corporate Communications T: +61 3 9639
6036 E: julie.meldrum@mesoblast.com
|
Schond
GreenwayInvestor RelationsT: +1 212 880
2060E: schond.greenway@mesoblast.com |
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