First Patients Dosed in Phase 2/3 Randomized Controlled Trial of Mesoblast’s Remestemcel-l for COVID-19 Acute Respiratory ...
May 06 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular
medicines for inflammatory diseases, today announced that the first
patients have been dosed in the 300-patient randomized
placebo-controlled Phase 2/3 trial in the United States of
Mesoblast’s allogeneic cellular medicine remestemcel-L in COVID-19
infected patients with moderate to severe acute respiratory
distress syndrome (ARDS) on ventilator support.
Mesoblast holds an Investigational New Drug (IND) application
cleared by the FDA for use of remestemcel-L in the treatment of
patients with COVID-19 ARDS. The clinical protocol for the Phase
2/3 trial is based on initial promising results from use of
remestemcel-L in patients with moderate to severe COVID-19 ARDS
under an emergency IND application or expanded access protocol at
The Mount Sinai Hospital in New York. The trial will randomize up
to 300 ventilator-dependent patients in intensive care units to
either remestemcel-L or placebo (1:1) on top of maximal care, in
line with specific guidance provided by the United States Food and
Drug Administration (FDA) for robust statistical analysis. The
primary endpoint is all-cause mortality within 30 days of
randomization, with the key secondary endpoint being the number of
days alive and off mechanical support.
The trial will include up to 30 sites across North America, with
patient screening and enrollment having already commenced at Baylor
University Medical Center, a part of Baylor Scott & White
Health; Cleveland Clinic, Duke University Hospital, Keck Medical
Center of USC, Lutheran Hospital Indiana, The Mount Sinai Hospital,
Ochsner Medical Center – Jefferson Highway, and the University of
Maryland School of Medicine/University of Maryland Medical Center.
Enrollment is expected to complete within three to four months,
with interim analyses planned which could result in stopping the
trial early for efficacy or futility.
The Clinical and Data Coordinating Center for the trial will be
overseen by Dr Annetine Gelijns, Dr Alan Moskowitz and Dr Emilia
Bagiella, the co-Directors of the Institute for Transformative
Clinical Trials at the Icahn School of Medicine at Mount Sinai.
Dr Moskowitz said: “This rapid mobilization of major medical
centers across the United States reflects the urgent need to treat
the very large numbers of people in hospital intensive care units
suffering with COVID-19 ARDS and requiring ventilation. We expect
quick enrollment in this trial to determine whether remestemcel-L
can reduce mortality in these patients.”
About Remestemcel-L Remestemcel-L is being
developed for various inflammatory conditions, including acute
graft versus host disease, and is believed to counteract the
inflammatory processes implicated in these diseases 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’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
steroid-refractory acute graft versus host disease (acute GVHD) has
been accepted for priority review by the United States Food and
Drug Administration (FDA). 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 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 include, but are not limited to, statements about the
initiation, timing, progress and results of Mesoblast and its
collaborators’ clinical studies; Mesoblast and its collaborators’
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; the potential
benefits of strategic collaboration agreements and Mesoblast’s
ability to maintain established strategic collaborations;
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; the scope of
protection Mesoblast is able to establish and maintain for
intellectual property rights covering its product candidates and
technology. 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
Greenway+212 880 2060E: schond.greenway@mesoblast.com |
Paul Hughes T: +61 3 9639
6036E: paul.hughes@mesoblast.com |
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