Mesoblast’s Phase 3 Trial of Revascor in Advanced Chronic Heart Failure Surpasses the Number of Primary Endpoint Events for...
December 17 2019 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that its
Phase 3 trial of Revascor for advanced chronic heart failure has
surpassed the number of primary endpoint events required for trial
completion. 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.
Once the last patient has completed their last visit, final data
collection and entry processes will be performed and the database
locked. All surviving patients will have been followed for at least
12 months, with a mean follow up period of approximately 30 months.
The results from this pivotal trial are expected to be read out by
mid-2020.
The double-blind, randomized, sham procedure-controlled Phase 3
trial is evaluating Revascor as an add-on treatment to
standard-of-care for reduction of recurrent non-fatal heart
failure-related major adverse cardiac events (HF-MACE) and terminal
cardiac events (TCEs) in 566 patients with advanced chronic heart
failure and reduced ejection fraction. The trial was designed to
accrue more than 531 total primary endpoint events (HF-MACE) based
on expected rates of HF-MACE in similarly advanced populations of
heart failure patients and on treatment benefits seen with Revascor
in earlier Phase 2 trial results. In April 2017, the Company
reported that a pre-specified interim futility analysis of the
primary efficacy endpoint in the Phase 3 trial’s first 270 patients
was successful.
In the United States alone, there are more than 6.5 million
patients with heart failure¹. Approximately 15% of this patient
population has advanced chronic heart failure and is at high-risk
for recurrent HF-MACE and TCEs. This high-risk group makes up the
predominant patient population in the Revascor Phase 3 trial.
Mesoblast Chief Executive Dr Silviu Itescu stated: "We are very
pleased to have achieved this important milestone in the largest
trial of cell-based therapy for patients with advanced heart
failure. These patients have exhausted other treatment
alternatives, and have the highest burden of disease, recurrent
hospitalizations and mortality."
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.
¹ Benjamin EJ, Virani SS, Callaway CW et al. American Heart
Association Council on Epidemiology and Prevention Statistics
Committee and Stroke Statistics Subcommittee. Heart Disease and
Stroke Statistics-2018 Update: A report from the American Heart
Association. Circulation.
2018;137:e67–e4922016;133:e38–e360.
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.
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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