Phase 3 Trial of Mesoblast’s Cell Therapy in Chronic Heart Failure Completes Recruitment
07 January 2019 - 10:00PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), world leader in
development and commercialization of allogeneic (off-the-shelf)
cellular medicines, today announced that it has completed
patient recruitment in the events-driven Phase 3 trial of its
product candidate Revascor (MPC-150-IM) for advanced chronic heart
failure.
Mesoblast Chief Executive Dr Silviu Itescu stated: “Completion
of recruitment in this Phase 3 trial, the largest cell therapy
trial for heart failure, is a key milestone for Mesoblast and has
been achieved on plan. This is a substantial step forward in our
objective to bring an effective therapy to countless patients
with progressive heart failure, and a tremendous commercial
opportunity for Mesoblast.”
The Phase 3 trial is evaluating whether Revascor reduces
recurrent non-fatal heart failure-related major adverse cardiac
events (HF-MACE), and prevents or delays terminal cardiac events
(TCEs), defined as cardiovascular death, heart transplant or
placement of an artificial device, over at least 12 months. In a
previous Phase 2 trial, a single dose of Revascor prevented any
TCEs or hospitalization events over three years in a similar
patient cohort.
The Phase 3 trial has enrolled approximately 570 patients
across 55 centers in North America. This enrollment target was
guided by the observed reduction in the event rate in the Phase 2
trial and reinforced by the successful outcome of a pre-specified
futility analysis of the Phase 3 trial’s primary endpoint performed
after the first 270 patients were enrolled.
The trial’s co-principal investigator, Dr Emerson Perin, Medical
Director of Texas Heart Institute and Director of its Stem
Cell Center, said: “We are very pleased to have completed
recruitment in this important trial of a cellular therapy for
advanced heart failure patients who have few alternatives. If the
Phase 3 trial results confirm the earlier Phase 2 data, where we
saw improvements in patient function as well as reductions in
hospitalizations and deaths, this important technology will
transform cardiovascular care and would provide a powerful new
treatment for advanced heart failure.”
There are over 8 million patients with heart failure in the
United States alone, with 15-20% refractory to all existing
medicines and progressing to advanced heart failure1 (New York
Heart Association Class III or IV). These patients represent
a major unmet medical need due to their high rates of HF-MACE
events and mortality.
Dr Itescu added: “Over the past 12 months, Mesoblast has
completed recruitment in all three of its Phase 3 trials, for acute
graft versus host disease, chronic low back pain, and now chronic
heart failure.”
About MesoblastMesoblast 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). www.mesoblast.com
1. AHA’s 2017 Heart Disease and Stroke Statistics Update
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For further information, please contact:
Julie MeldrumCorporate
CommunicationsT: +61 3 9639
6036E: julie.meldrum@mesoblast.com |
Schond GreenwayInvestor
RelationsT: +1 212 880
2060E: schond.greenway@mesoblast.com |
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