FDA Clearance Received for Heart Attack Stem Cell Clinical Trial
02 Maio 2007 - 10:00AM
PR Newswire (US)
Platform stem cell technology now in two major US-based trials
MELBOURNE, Australia, May 2 /PRNewswire-FirstCall/ -- Australia's
adult stem cell company, Mesoblast Limited (ASX: MSB; US OTC:
MBLTY), today announced that the United States Food and Drug
Administration (US FDA) has cleared the Investigational New Drug
Submission (IND) of its US-based sister company, Angioblast Systems
Inc., to commence a Phase 2 clinical trial of its allogeneic, or
'off-the-shelf', adult stem cells for patients with heart attacks.
"FDA clearance is a significant step towards commercialising our
stem cell products in the US, the world's largest market for
cardiovascular diseases," said founder and Chief Scientific
Adviser, Professor Silviu Itescu. "Importantly FDA clearance was
obtained within 30 days of the submission of the IND," he said. The
Phase 2 clinical trial will be based at the Texas Heart Institute,
and will follow a similar protocol to the one used by the same
investigators in preclinical studies for the IND submission. These
showed that implantation of the company's proprietary allogeneic
stem cells by catheter into damaged heart muscle resulted in
significant improvement in heart function and reduction in
congestive heart failure. This clinical trial will be the first to
test an allogeneic stem cell product injected by catheter into
heart muscle damaged by a recent heart attack. The trial will use
the latest generation catheters provided through Angioblast's
ongoing relationship with the Johnson & Johnson companies,
Cordis Corporation and Biosense Webster. The commercial strategy
for both Mesoblast and Angioblast is to generate high margin stem
cell products that are obtained from a single donor, expanded,
frozen, and subsequently used in thousands of unrelated, or
allogeneic, recipients at the time and place of need. Over one
million new patients with heart attacks are treated annually in the
US alone, representing a multi-billion dollar market opportunity.
Current therapies do not result in rebuilding of heart muscle, and
do not prevent progression of congestive heart failure, poor
quality of life, and long-term deterioration. For further
information, please contact: Julie Meldrum Corporate Communications
Director Mesoblast Limited T: +61 3 9639 6036 M: +61 419 228 128 E:
W: http://www.mesoblast.com/ DATASOURCE: Mesoblast Limited CONTACT:
Julie Meldrum, Corporate Communications Director, Mesoblast, +61 3
9639 6036 or (cell) +61 419 228 128, Web site:
http://www.mesoblast.com/
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