Randomized Controlled Phase 3 Trial of Remestemcel-L for Reduced Mortality in COVID-19 Acute Respiratory Distress Syndrome Su...
October 13 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, announced
today that the randomized controlled Phase 3 trial of remestemcel-L
on top of maximal care in ventilator-dependent patients with acute
respiratory distress syndrome (ARDS) due to COVID-19 infection has
surpassed 50% enrollment. The trial’s primary endpoint is reduction
in 30-day mortality relative to maximal care. ARDS continues to be
the primary cause of death in COVID-19 patients.
Mesoblast Chief Medical Officer Dr Fred Grossman said: “There is
an urgent need for targeted treatments to reduce the continued high
mortality in COVID-19 ARDS patients who are dependent on mechanical
ventilators. We expect to complete the enrollment
target in this important trial by the end of the
year as the enrollment rate continues to increase in line with
the surge in new infections across the United States.”
The randomized, double-blinded, controlled trial is enrolling up
to 300 ventilator-dependent patients with moderate to severe ARDS,
and aims to confirm findings from a pilot study at New York’s Mt
Sinai Hospital in March-April this year. In that study, nine of 12
ventilator-dependent patients (75%) were successfully discharged
from hospital a median of 10 days after receiving two intravenous
doses of remestemcel-L within five days. The United States Food and
Drug Administration (FDA) cleared the Phase 3 trial to commence
enrollment following a review of the trial design and clinical
endpoints.
Remestemcel-L is being developed for the treatment of severe
diseases associated with excessive cytokine storm, including
COVID-19 ARDS and acute graft versus host disease. The ability to
reduce production of damaging pro-inflammatory cytokines, which are
central to tissue damage in both ARDS and acute GVHD, provides a
unifying mechanism of action for remestemcel-L in the treatment of
these diseases. The results from the randomized controlled Phase 3
trial in COVID-19 ARDS patients, if positive, will build upon the
totality of the evidence for the effectiveness of remestemcel-L in
adults and children with severe and life-threatening inflammatory
conditions.
The trial’s independent Data Safety Monitoring Board (DSMB)
recently completed an interim analysis of safety and efficacy
including primary endpoint of all-cause mortality within 30 days of
randomization of the trial’s first 90 enrolled patients and
recommended that the trial continue as planned. The DSMB will
perform a second interim analysis in early November when 45% of the
enrollment target has completed 30 days of follow-up.
About Remestemcel-LMesoblast’s lead product
candidate, remestemcel-L, is an investigational therapy comprising
culture-expanded mesenchymal stem cells derived from the bone
marrow of an unrelated donor. It is thought 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.
Remestemcel-L is being developed for inflammatory diseases in
children and adults including steroid-refractory acute graft versus
host disease and moderate to severe acute respiratory distress
syndrome. 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
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timing, progress and results of Mesoblast’s preclinical and
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into, enroll and successfully complete, clinical studies; the
timing or likelihood of regulatory filings and approvals; and the
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ability to successfully defend these in cases of alleged
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our website. Uncertainties and risks that may cause Mesoblast’s
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statements, and accordingly, you should not place undue reliance on
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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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