Mesoblast To Evaluate Anti-Inflammatory Cell Therapy Remestemcel-L For Treatment Of COVID-19 Lung Disease
March 10 2020 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX:MSB) today announced that it
plans to evaluate its allogeneic mesenchymal stem cell (MSC)
product candidate remestemcel-L in patients with acute respiratory
distress syndrome (ARDS) caused by coronavirus (COVID-19) in the
United States, Australia, China and Europe. The Company is in
active discussions with various government and regulatory
authorities, medical institutions and pharmaceutical companies to
implement these activities.
Mortality in COVID-19 infected patients with the inflammatory
lung condition acute respiratory distress syndrome (ARDS) is
reported to approach 50%, and is associated with older age,
co-morbidities such as diabetes, higher disease severity, and
elevated markers of inflammation.1 Current therapeutic
interventions do not appear to be improving in-hospital
survival.1
Remestemcel-L has potential for use in the treatment of ARDS,
which is the principal cause of death in COVID-19 infection.1 This
is supported by recently published results from an
investigator-initiated clinical study conducted in China which
reported that allogeneic MSCs cured or significantly improved
functional outcomes in all seven treated patients with severe
COVID-19 pneumonia.2
Additionally, in post-hoc analyses of a 60-patient randomized
controlled study in chronic obstructive pulmonary disease (COPD),
remestemcel-L infusions were well tolerated, significantly reduced
inflammatory biomarkers, and significantly improved pulmonary
function in those patients with elevated inflammatory biomarkers.
Since the same inflammatory biomarkers are also elevated in
COVID-19, these data suggest that remestemcel-L could be useful in
the treatment of patients with ARDS due to COVID-19. The COPD
study results have been submitted for presentation at an
international conference, with full results to be submitted for
publication shortly.
Remestemcel-L is being studied in numerous clinical trials
across several inflammatory conditions, including in elderly
patients with lung disease and adults and children with
steroid-refractory acute graft versus host disease
(aGVHD).3-5 This product candidate is currently being
reviewed by the United States Food and Drug Administration (FDA)
for potential approval in the treatment of children with
steroid-refractory aGVHD.
Remestemcel-L Remestemcel-L is being developed
for rare pediatric and adult inflammatory conditions. It is an
investigational therapy comprising culture-expanded MSCs derived
from the bone marrow of an unrelated donor and is administered in a
series of intravenous infusions. Remestemcel-L is believed to have
immunomodulatory properties to counteract the inflammatory
processes that are implicated in several 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.
Intellectual PropertyMesoblast’s intellectual
property (IP) portfolio encompasses over 1,000 patents or patent
applications in all major markets and includes the use of MSCs
obtained from any source for patients with acute respiratory
distress syndrome (ARDS), and for inflammatory lung disease
due to coronavirus (COVID-19), influenza and other viruses.
Additionally, these patents cover Mesoblast’s manufacturing
processes that yield industrial-scale cellular medicines. This
IP position is expected to provide Mesoblast with substantial
commercial advantages as it develops its product candidates for
these conditions.
References1. Liu Y et al. Clinical features and
progression of acute respiratory distress syndrome in coronavirus
disease 2019. Medrxiv 2020;
https://doi.org/10.1101/2020.02.17.200241662. Leng Z, et al.
Transplantation of ACE2- Mesenchymal Stem Cells Improves the
Outcome of Patients with COVID-19 Pneumonia[J]. Aging and Disease,
10.14336/AD.2020.02283. Kurtzberg J et al. Annual Meeting of the
American Society for Transplantation Cell Therapy, 2020. 4.
Chaudhury S et al. A Phase 3 Single-Arm, Prospective Study of
Remestemcel-L, Ex-Vivo Cultured Adult Human Mesenchymal Stromal
Cells, for the Treatment of Steroid Refractory Acute GVHD in
Pediatric Patients. Biol Blood Marrow Transplant 2018;
24:S119–S290. 5. Kurtzberg J et al. Allogeneic human mesenchymal
stem cell therapy (remestemcel-L, Prochymal) as a rescue agent for
severe refractory acute graft-versus-host disease in pediatric
patients. Biol Blood Marrow Transplant. 2014 Feb;20(2):229-35.
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 has filed a Biologics License Application to the
United States Food and Drug Administration (FDA) to seek approval
of its product candidate RYONCIL™ (remestemcel-L) for
steroid-refractory acute graft versus host disease (acute GvHD).
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 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
initiation, timing, progress and results of Mesoblast’s preclinical
and clinical studies, and Mesoblast’s research and development
programs; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory
filings and approvals, manufacturing activities and product
marketing activities, if any; the commercialization of Mesoblast’s
product candidates, if approved; regulatory or public perceptions
and market acceptance surrounding the use of stem-cell based
therapies; the potential for Mesoblast’s product candidates, if any
are approved, to be withdrawn from the market due to patient
adverse events or deaths; the potential benefits of strategic
collaboration agreements and Mesoblast’s ability to enter into and
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; estimates of
Mesoblast’s expenses, future revenues, capital requirements and its
needs for additional financing; Mesoblast’s financial performance;
developments relating to Mesoblast’s competitors and industry; and
the pricing and reimbursement of Mesoblast’s product candidates, if
approved. 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 |
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Schond Greenway |
Corporate Communications |
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Investor Relations |
T: +61 3 9639 6036 |
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T: +1 212 880 2060 |
E: julie.meldrum@mesoblast.com |
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E: schond.greenway@mesoblast.com |
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