FDA CLEARS INVESTIGATIONAL NEW DRUG APPLICATION FOR MESOBLAST TO USE REMESTEMCEL-L IN PATIENTS WITH ACUTE RESPIRATORY DISTRES...
April 06 2020 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in
cellular medicines for inflammatory diseases, today announced that
it has received clearance from the United States Food and Drug
Administration (FDA) for an Investigational New Drug (IND)
application to treat patients with acute respiratory distress
syndrome (ARDS) caused by coronavirus infection (COVID-19) with
intravenous infusions of its allogeneic mesenchymal stem cell (MSC)
product candidate remestemcel-L.
Mesoblast Chief Medical Officer Dr Fred Grossman said: “The FDA
clearance provides a pathway in the United States for use of
remestemcel-L in patients with COVID-19 ARDS, where the prognosis
is very dismal, under both expanded access compassionate use and in
a planned randomized controlled trial.”
Remestemcel-L is being developed for various inflammatory
conditions, 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. The
safety and therapeutic effects of remestemcel-L intravenous
infusions have been evaluated in over 1,100 patients in various
clinical trials.
Remestemcel-L was successful in a Phase 3 trial for
steroid-refractory acute graft versus host disease (aGVHD) in
children, a potentially fatal inflammatory condition due to a
similar cytokine storm process as is seen in COVID-19
ARDS. Additionally, a post-hoc analysis of a randomized,
placebo-controlled study in 60 patients with chronic obstructive
pulmonary disease demonstrated that remestemcel-L significantly
improved respiratory function in patients with the same elevated
inflammatory biomarkers that are also observed in patients with
COVID-19 ARDS. Together, these outcomes provide the rationale for
evaluating remestemcel-L in patients with COVID-19 ARDS.
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 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:
Julie Meldrum
Corporate Communications
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com
Schond GreenwayInvestor Relations T: +1 212 880 2060E:
schond.greenway@mesoblast.com
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