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 angioplasty and stent procedure, within 12
hours of the heart attack. In preclinical trials, a simple
intracoronary infusion of Mesoblast's off-the-shelf MPCs increased
the number of blood vessels in the infarcted region, prevented scar
formation, and significantly improved heart muscle function after a
heart attack, preventing heart failure.
"The preclinical data were very compelling, and formed the basis
for this innovative clinical trial," said the study's Principal
Investigator, Professor Eric
Duckers, M.D., Ph.D., Interventional Cardiologist, Head of
Molecular Cardiology & Associate Professor, Thoraxcenter,
Erasmus University Hospital in
The Netherlands.
"We are excited to be pioneering a novel and minimally invasive
clinical approach that has the potential to greatly improve the
quality of life for patients suffering acute heart attacks,"
Professor Duckers added.
The UK's lead investigator, Dr Jonathan
Hill, Consultant Interventional Cardiologist at King's
College Hospital and King's Health Partners Academic Health
Sciences Centre, said: "This stem cell product has the potential to
change the medical paradigm for treatment of large heart attacks,
and to provide for the first time a validated and effective
off-the-shelf therapy for routine use."
Mesoblast Chief Executive Professor Silviu Itescu said the company was delighted to
be progressing into a second major clinical indication for its
proprietary stem cell product Revascor(TM), which is already well
advanced in clinical development for congestive heart failure, with
plans to expand its use for chronic refractory angina.
"If the preclinical results are reproduced in this trial, we
will have a product that will make a significant impact on the
lives of patients after a debilitating heart attack," Professor
Itescu added.
Mesoblast has a strategic partnership with United States biopharmaceutical company
Cephalon Inc. to commercialize Revascor(TM) for the broad treatment
of cardiovascular diseases.
About Mesoblast
Mesoblast Limited (ASX: MSB) is a world leader in
commercialising biologic products for the broad field of
regenerative medicine. Mesoblast has the worldwide exclusive rights
for a series of patents and technologies developed over more than
10 years relating to the identification, extraction, culture and
uses of adult Mesenchymal Precursor Cells (MPCs).
www.mesoblast.com
Notes to Editors
1. King's College Hospital NHS Foundation Trust is a major
centre for the treatment of heart attacks. King's is one of the
UK's largest and busiest teaching hospitals, with nearly 7,000
staff providing around 1,000, 000 patient contacts a year. King's
has a unique profile, with a full range of local hospital services
for people in the London boroughs
of Lambeth and Southwark as well as specialist services to patients
from further afield. The Trust is recognized internationally for
its work in liver disease and transplantation, neurosciences,
cardiac, haemato-oncology, stroke and major trauma. King's also
plays a key role in the training and education of medical, nursing
and dental students with its academic partner, King's College
London. For more information, visit http://www.kch.nhs.uk
2. King's College Hospital and Guy's and St Thomas' are both
part of King's Health Partners Academic Health Sciences Centre
(AHSC), a pioneering collaboration between King's College London,
and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation
Trusts. King's Health Partners is one of only five AHSCs in the UK
and brings together an unrivalled range and depth of clinical and
research expertise, spanning both physical and mental health. Our
combined strengths will drive improvements in care for patients,
allowing them to benefit from breakthroughs in medical science and
receive leading edge treatment at the earliest possible
opportunity. For more information, visit
http://www.kingshealthpartners.org
For further information, please contact:
Julie Meldrum
Corporate Communications Director
Mesoblast Limited
T: + 61 (0)3 9639 6036
M:+ 61(0) 419228 128
E: julie.meldrum@mesoblast.com
For media enquiries in Europe,
please contact:
Sue Charles/Melanie Toyne Sewell/Gemma Howe
College Hill Life Sciences
T: +44 (0)20 7866 7863 or +44 (0)7968 7256585
E: mesoblast@collegehill.com
SOURCE Mesoblast