Mesoblast to Present Positive Clinical Outcomes Using Remestemcel-L in Patients With Inflammatory Lung Disease at 2020 Intern...
April 17 2020 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX:MSB) today announced that
results using its allogeneic mesenchymal stem cell product
candidate remestemcel-L in patients with inflammatory lung disease
have been selected for oral presentation at the 2020 International
Society of Cell and Gene Therapy (ISCT) annual meeting being held
May 28-29, 2020. The virtual presentation is entitled ‘Mesenchymal
Stem Cell Therapy Improves Pulmonary Function and Exercise
Tolerance in Patients with Chronic Obstructive Pulmonary Disease
(COPD) and High Baseline Inflammation’.
The post-hoc analysis from a randomized, placebo-controlled
60-patient Phase 2 trial in patients with COPD showed that
remestemcel-L significantly improved respiratory and functional
clinical outcomes in patients with elevated levels of the
inflammatory biomarker C-reactive protein (CRP). Significantly
elevated CRP levels are also observed in patients with various
acute lung diseases, including acute respiratory distress syndrome
(ARDS), a life-threatening complication of COVID-19.
These data formed part of the clinical justification in support
of Mesoblast’s submission to the United States Food and Drug
Administration (FDA) for an Investigational New Drug (IND)
application evaluating remestemcel-L in the treatment of patients
with COVID-19 ARDS. Under this IND, the FDA cleared Mesoblast
to proceed with the expanded access compassionate use program and a
randomized controlled trial in patients with moderate to severe
ARDS from COVID 19.
Mesoblast Chief Medical Officer Dr Fred Grossman said: “We are
very encouraged by the positive clinical outcomes seen with
intravenous infusions of remestemcel-L in patients with chronic
inflammatory lung disease. These outcomes, together with
results of remestemcel-L in patients with acute graft versus host
disease, another condition associated with excessive cytokine
release, have provided the strong rationale for the evaluation of
remestemcel-L in patients with acute inflammatory conditions,
including 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 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:
Media Julie
MeldrumT: +61 3 9639 6036E:julie.meldrum@mesoblast.com |
Kristen Bothwell T: +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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