Circulation Research Special Article Highlights Potential Of Mesoblast Cell Therapy In Treatment Of Advanced Heart Failure
July 25 2019 - 6:00AM
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that
premier cardiovascular journal Circulation Research has
published a Special Article highlighting the important potential
clinical benefits of Mesoblast’s allogeneic mesenchymal precursor
cell (MPC) technology platform as immunotherapy in patients
with advanced chronic heart failure.
The Special Article highlighted that cardiac inflammation drives
heart failure progression, and concluded that based on preclinical
and Phase 2 clinical data there is a biologic rationale for the use
of Mesoblast’s MPCs in targeting this inflammatory process in order
to improve heart failure outcomes.
The manuscript, titled ‘Phase 3 DREAM-HF Trial of Mesenchymal
Precursor Cells in Chronic Heart Failure; A Review of Biological
Plausibility and Implementation of Flexible Clinical Trial
Design,’ was requested by the journal’s Editor-in-Chief. Its
authors include the Phase 3 trial’s co-principal investigators, Dr
Emerson Perin, Texas Heart Institute, and Dr Barry Greenberg,
University of California, San Diego Healthcare System. The article
can be accessed
at https://doi.org/10.1161/CIRCRESAHA.119.314951.
The ongoing, placebo-controlled double-blind Phase 3
trial of Mesoblast’s heart failure cellular medicine Revascor,
comprising 150 million MPCs, is evaluating the
immunotherapy for reduction of heart failure-related
hospitalizations and terminal cardiac events in patients with
advanced heart failure. The events-driven trial completed
enrollment of 566 patients in February 2019, and was
previously successful in a pre-specified interim futility
analysis of the primary efficacy endpoint in the first 270
patients.
Revascor is also being evaluated to prevent mucosal bleeding in
end-stage chronic heart failure patients with a Left Ventricular
Assist Device (LVAD) and recently received Orphan Drug Designation
from the United States Food and Drug Administration (FDA) for this
indication. Mesoblast is in discussions with the FDA regarding
a potential approval pathway under the product’s existing
Regenerative Medicine Advanced Therapy (RMAT) designation for this
life-threatening condition.
About Mesoblast Mesoblast Limited (Nasdaq:MESO;
ASX:MSB) has leveraged its proprietary technology platform to
establish a broad portfolio of late-stage allogeneic
(off-the-shelf) product candidates with three product candidates in
Phase 3 trials – acute graft versus host disease, chronic heart
failure and chronic low back pain due to degenerative disc disease.
Through a proprietary process, Mesoblast selects rare mesenchymal
lineage precursor and stem cells from the bone marrow of healthy
adults and creates master cell banks, which can be industrially
expanded to produce thousands of doses from each donor that meet
stringent release criteria, have lot to lot consistency, and can be
used off-the-shelf without the need for tissue matching. Mesoblast
has facilities in Melbourne, New York, Singapore and Texas and is
listed on the Australian Securities Exchange (MSB) and on the
Nasdaq (MESO). For more information about Mesoblast, visit
www.mesoblast.com.
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, including
Revascor, 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.
For further information, please contact: |
|
|
|
|
Julie Meldrum |
|
|
Schond Greenway |
Corporate Communications |
|
|
Investor Relations |
T: +61 3 9639 6036 |
|
|
T: +1 212 880 2060 |
E: julie.meldrum@mesoblast.com |
|
|
E: schond.greenway@mesoblast.com |
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jul 2023 to Jul 2024