Remestemcel-L to be Evaluated as Treatment for Chronic Graft Versus Host Disease in Planned Investigator-Initiated Trial
August 14 2019 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular
medicines for inflammatory diseases, today announced that it
intends to provide its allogeneic cell therapy product candidate
remestemcel-L for evaluation under an investigator-initiated
Investigational New Drug (IND) submission as a potential treatment
in children with
steroid-refractory chronic graft-versus-host disease
(GVHD). The lead investigator will be Dr Joanne
Kurtzberg, Jerome Harris Distinguished Professor of Pediatrics
and Professor of Pathology, and Director, Pediatric Blood
and Marrow Transplant Program at Duke University Medical Center.
In both acute and chronic forms of GVHD, the
donated bone marrow stem cells view the recipient’s body as
foreign, and attack the body causing significant morbidity and
mortality. Acute GVHD usually manifests within 100 days following a
transplant while chronic GVHD generally manifests
later (>100 days), and the two may occur separately or within
the same patient.
The incidence of chronic GVHD is increasing and occurs
in 30-70% of recipients of both related and unrelated bone marrow
transplants.1,2 There are no therapies approved by the United
States Food and Drug Administration (FDA) in the 50% of children
with chronic GVHD who fail steroids. Mesenchymal stem
cells have been used successfully in patients with
steroid-refractory chronic GVHD and have been reported to
result in durable responses in up to 75% of patients.3-5
Dr Kurtzberg said: “Given my experience with achieving
successful outcomes with remestemcel-L in children with
steroid-refractory acute GVHD, I look forward to
evaluating the treatment’s potential as salvage therapy
in chronic GVHD, where there remains a significant unmet
need.”
Earlier this year, Mesoblast initiated filing of a rolling
submission for a Biologics License Application (BLA) to the FDA for
the use of remestemcel-L in children with steroid-refractory acute
GVHD. This BLA submission is based on a successful Phase 3 trial in
55 children with steroid-refractory acute GVHD and supporting
results from an Expanded Access Program (EAP) in 241
children. Dr Kurtzberg was the Principal Investigator in both
trials.
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 technology platform to establish a broad portfolio of
late-stage 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 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). www.mesoblast.com
1. Arai et al. Biol Blood Marrow Transplant. 2015; 21(2):
266–274.2. Grube et al. Biol Blood Marrow Transplant: 2016; 22
(11): 1781-1793. Went et al. Bone Marrow Transplantation 2010;
45:1732-1740.4. Shai et al. Blood 2013; 122:3294.5. von Bahr et al.
Blood 2015; 126:3138.
Forward-Looking Statements This 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 in aGVHD; Mesoblast’s ability to advance its aGVHD product
candidate into, enroll and successfully complete, clinical studies;
the timing or likelihood of regulatory filings and approvals for
aGVHD; 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.
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 |
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