Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced that a randomized, controlled study of remestemcel-L
delivered by an endoscope directly to the areas of inflammation and
tissue injury in up to 48 patients with medically refractory
Crohn’s disease and ulcerative colitis has commenced at Cleveland
Clinic.
Mesoblast Chief Medical Officer Dr Fred Grossman
said: “Inflammation of the gut in Crohn’s disease and ulcerative
colitis closely resembles the most severe manifestation of
advanced-stage, life-threatening acute graft versus host disease
(aGVHD). Mesoblast’s objective is to confirm the potential for
remestemcel-L to induce luminal healing and early remission in a
wider spectrum of diseases with severe inflammation of the gut, in
addition to steroid-refractory aGVHD.”
Mesenchymal stem cells (MSCs) promote healing of
inflamed gut tissue by downregulating gut mucosal effector T-cell
activity and promoting regulatory T-cell formation.1 MSCs have been
tested in clinical trials of Crohn’s disease using two different
modalities: intravenous infusions of MSCs to treat the primary
inflammation of Crohn’s disease and local injections of MSCs to
treat fistulae complicating Crohn’s disease.
A third modality, endoscopic delivery of MSCs, has
been successful in preclinical experimental models of colitis,
reducing the excessive cytokine storm in the inflamed gut and
resulting in tissue healing.2-3 The study at Cleveland Clinic will
be the first in humans using local delivery of MSCs in the gut, and
will enable Mesoblast to compare clinical outcomes using this
delivery method with results from an ongoing randomized,
placebo-controlled trial in patients with biologic-refractory
Crohn’s disease where remestemcel-L was administered
intravenously.
The study’s lead investigator Dr Amy L. Lightner,
Associate Professor of Surgery in the Department of Colon and
Rectal Surgery at Cleveland Clinic, stated: “We are aiming to
establish a new treatment paradigm by administering remestemcel-L
at one of two escalating doses, or placebo, directly to inflamed
gut tissue in patients with medically refractory Crohn’s disease
and ulcerative colitis, both highly debilitating conditions with
significant, unmet medical needs.”
According to recent estimates, more than three
million people (1.3%) in the US alone have inflammatory bowel
disease, with more than 33,000 new cases of Crohn’s disease and
38,000 new cases of ulcerative colitis diagnosed every year.4-6
Despite recent advances, approximately 30% of patients are
primarily unresponsive to anti-TNFα agents and even among
responders, up to 10% will lose their response to the drug every
year. Up to 80% of patients with medically-refractory Crohn’s
disease eventually require surgical treatment of their disease,7
which can have a devastating impact on quality of life.
References 1.Mayne C and
Williams C. Induced and natural regulatory T cells in the
development of inflammatory bowel disease. Inflamm Bowel Dis 2013;
19: 1772–1788. 2.Molendijk I et al. Intraluminal Injection of
Mesenchymal Stromal Cells in Spheroids Attenuates Experimental
Colitis. Journal of Crohn's and Colitis, 2016, 953–964 3.Pak S eta
al. Endoscopic Transplantation of Mesenchymal Stem Cell
Sheets in Experimental Colitis in Rats. Scientific Reports |
(2018) 8:11314 | DOI:10.1038/s41598-018-29617 4.CDC Facts and
Figures 2015 5.Globaldata Pharmapoint 2018 6.Dahlhamer JM, MMWR
Morb Mortal Wkly Rep. 2016;65(42):1166–1169. 7.Crohn’s and Colitis
Foundation
About Remestemcel-L Mesoblast’s
lead product candidate, remestemcel-L, is an investigational
therapy comprising culture-expanded mesenchymal stem cells derived
from the bone marrow of an unrelated donor. It is administered to
patients in a series of intravenous infusions. Remestemcel-L is
thought to have immunomodulatory properties to counteract severe
inflammatory processes 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.
About Mesoblast Mesoblast 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 has a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 in all major markets. The Company’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.
Remestemcel-L is being developed for inflammatory
diseases in children and adults including steroid-refractory acute
graft versus host disease and moderate to severe acute respiratory
distress syndrome. Mesoblast is completing Phase 3 trials for its
product candidates for advanced heart failure and chronic low back
pain. 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 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
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historical fact are forward-looking statements, which are often
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“estimate,” “expect,” “goal,” “intend,” “likely,” “look forward
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make such forward-looking statements pursuant to the safe harbor
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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
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adverse. The risks, uncertainties and other factors that may impact
our 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
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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
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future developments or otherwise.
Release authorized by the Chief Executive.
For further information, please contact:
Media Julie Meldrum T: +61 3 9639 6036
E:julie.meldrum@mesoblast.com |
Kristen Bothwell T: +1 917 613 5434
E:kbothwell@rubenstein.com |
|
|
Investors Schond Greenway T: +212 880 2060
E: schond.greenway@mesoblast.com |
Paul
Hughes T: +61 3 9639 6036
E: paul.hughes@mesoblast.com |
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