Mesoblast Receives Ethics Approval to Treat COVID-19 Patients in Australia
September 02 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced that it has received ethics approval to include
Australian hospitals in the Phase 3 randomized controlled trial of
remestemcel-L in ventilator-dependent COVID-19 patients with acute
respiratory distress syndrome (ARDS).
Participating hospitals in Melbourne and Sydney have been
granted approval by the Human Research Ethics Committee of Monash
Health and will join more than 17 leading US medical centers
already in the Phase 3 trial. This study is being conducted by the
US National Institutes of Health–funded Cardiothoracic Surgical
Trials Network, and cleared by the US Food and Drug Administration
(FDA).
Mesoblast Chief Executive Dr Silviu Itescu stated: “As an
Australian company developing a potential treatment for
COVID-19 ARDS, the primary cause of death in patients infected with
COVID-19, we have a responsibility to evaluate remestemcel-L in
Australian patients as the country continues to grapple with
COVID-19.”
Principal Investigator A/Prof. Tony Goldschlager said: “We are
pleased that Monash Health is involved in this important COVID-19
trial, especially given the extensive experience we have had with
Mesoblast’s mesenchymal lineage cells.”
The clinical protocol evaluating remestemcel-L in up to 300
patients in the Phase 3 trial was based on results from a pilot
study using remestemcel-L under emergency compassionate care at Mt
Sinai Hospital in New York, with 75% (nine of 12) of patients with
moderate to severe ARDS successfully taken off a ventilator and
discharged from hospital within a median of 10 days. The Phase 3
trial is enrolling ventilator-dependent patients in intensive care
units with moderate to severe COVID-19 ARDS randomized
(1:1) to receive either two intravenous infusions of remestemcel-L
three to five days apart or placebo on top of maximal care. The
primary endpoint is all-cause mortality within 30 days of
randomization, with the key secondary endpoint being the number of
days off mechanical ventilator support.
The trial’s independent Data Safety Monitoring Board (DSMB)
plans to complete an interim analysis this month in the trial’s
first 90 patients randomized in the US after they have completed 30
days of follow up. After review of the safety and efficacy data,
the DSMB will provide a recommendation to Mesoblast on whether the
trial should proceed as planned, or stop early.
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. 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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