Data Safety Monitoring Board Recommends Continuation of Remestemcel-L Phase 3 Trial in COVID-19 Patients With Acute Respirato...
September 04 2020 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that the
independent Data Safety Monitoring Board (DSMB) recommended
continuation of the Phase 3 trial of remestemcel-L
in patients with moderate to severe acute respiratory distress
syndrome (ARDS) due to COVID-19 infection, following completion of
trial’s first interim analysis. The analysis was performed on the
first 30% of the total target of randomized patients, with the DSMB
reviewing the trial’s primary endpoint, all-cause mortality within
30 days of randomization and all safety data.
Mesoblast Chief Medical Officer Dr Fred Grossman
said: “We are very pleased with the recommendation by the DSMB.
This important trial seeks to confirm whether remestemcel-L
improves survival in ventilated COVID-19 patients with moderate to
severe ARDS, where death rates remain high despite best existing
treatments.”
The multi-center study includes three interim
analyses for stopping accrual early for efficacy or futility when
30%, 45% and 60% of the total target of randomized patients have
reached the primary endpoint. Up to 300 patients are planned to be
randomized 1:1 in the double-blinded Phase 3 trial to receive
either two intravenous infusions of remestemcel-L within five days,
or placebo, on top of maximal care. The primary endpoint is
all-cause mortality within 30 days of randomization. The key
secondary endpoint is days alive off mechanical ventilatory support
within 60 days of randomization. The trial is expected to
complete recruitment during Q4 CY2020.
About Remestemcel-LMesoblast’s
lead allogeneic cell therapy product candidate, remestemcel-L, is
an investigational therapy comprising culture-expanded mesenchymal
stem cells derived from the bone marrow of an unrelated donor.
Remestemcel-L is believed to have immunomodulatory properties to
counteract the cytokine storms that are implicated in various
inflammatory conditions by down-regulating the production of
pro-inflammatory cytokines, increasing production of
anti-inflammatory cytokines, and enabling recruitment of naturally
occurring anti-inflammatory cells to involved tissues.
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 mesenchymal lineage cell therapy technology platform to
establish a broad portfolio of commercial products and late-stage
product candidates. Mesoblast has a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 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’s Biologics License Application to seek approval of
its product candidate RYONCIL™ (remestemcel-L) for pediatric
steroid-refractory acute graft versus host disease has been
accepted for priority review by the United States Food and Drug
Administration (FDA), and if approved, product launch in the United
States is expected in 2020. Remestemcel-L is also being developed
for other inflammatory diseases in children and adults including
moderate to severe acute respiratory distress syndrome (ARDS).
Mesoblast is completing Phase 3 trials for its product candidates
for advanced heart failure and chronic low back pain. 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
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;
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
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:
MediaJulie MeldrumT: +61 3 9639
6036E: julie.meldrum@mesoblast.com |
Kristen BothwellT: +1 917 613
5434E: kbothwell@rubenstein.com |
InvestorsSchond
GreenwayT: +212 880 2060E: schond.greenway@mesoblast.com |
Paul HughesT: +61 3 9639
6036E: paul.hughes@mesoblast.com |
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