MELBOURNE, Australia, Sept. 5, 2011 /PRNewswire/ — Global
regenerative medicine company, Mesoblast Limited, (ASX: MSB), today
announced that it had received clearance from the European
Medicines Agency (EMA) to begin a 225-patient multi-center Phase 2
clinical trial in Europe for its lead cardiovascular product
Revascor(TM) in conjunction with angioplasty and stent procedures
to prevent heart failure after a major heart attack. Revascor(TM)
is an allogeneic, or “off-the-shelf”, adult stem cell product
derived from Mesoblast’s proprietary Mesenchymal Precursor Cell
(MPC) platform technology which is being developed for use in a
range of cardiovascular diseases including congestive heart
failure, chronic angina, and heart attacks (acute myocardial
infarction).
The placebo-controlled Phase 2 trial, AMICI (Allogeneic
Mesenchymal precursor cell Infusion in myoCardial Infarction), is
approved under Europe’s voluntary harmonization procedure and will
initially recruit patients at multiple European sites, including in
the United Kingdom, The Netherlands and Belgium. Trial recruitment
is subsequently expected to involve sites in additional European
nations, Australia, and the United States. The primary endpoint of
the study will be safety and efficacy at six months in heart attack
patients who will receive either Revascor(TM) at one of two doses
or placebo. Durability of effect will additionally be monitored for
up to 36 months.
Heart attacks remain the biggest killer of people in the
industrialized world. Every year, over 1.7 million people have a
heart attack in Europe, and over 1.1 million in the United States.
Most of these patients undergo an early angioplasty of the blocked
artery accompanied by implantation of a metal stent to keep the
artery open long-term. However, a significant number of the
surviving patients subsequently become disabled with heart
failure.
Revascor(TM) is injected by a simple intracoronary infusion at
the same time as the
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