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: julie.meldrum@mesoblast.com
W: http://www.mesoblast.com
SOURCE Mesoblast Limited
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Related links:
http://www.mesoblast.com/
CONTACT:
Julie Meldrum, Corporate Communications
Director, Mesoblast, +61 3 9639 6036 or (cell) +61 419 228 128,
julie.meldrum@mesoblast.com
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