Aastrom Receives Orphan Drug Designation from FDA for Dilated Cardiomyopathy
February 01 2007 - 7:00AM
PR Newswire (US)
- Up to 150,000 People in U.S. Currently Suffer from this Severe
Chronic Heart Disease ANN ARBOR, Mich., Feb. 1
/PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (NASDAQ:ASTM),
a company focused on the use of autologous cells for regenerative
medicine, today announced that the Company's proprietary Tissue
Repair Cells (TRCs) received an Orphan Drug Designation from the
U.S. Food and Drug Administration (FDA) for use in the treatment of
dilated cardiomyopathy (DCM), a severe chronic disease of the
heart. In the U.S., Orphan Drug Designation provides a variety of
incentives, including 7 years of market exclusivity, should TRCs
receive FDA approval for this indication. (Logo:
http://www.newscom.com/cgi-bin/prnh/20070117/CLW099LOGO ) DCM is a
chronic cardiac disease that leads to enlargement of the heart and
reduces pump function to a point that normal blood circulation
cannot be maintained. Typically patients with DCM present with
symptoms of congestive heart failure, including limitations in
their physical activity and shortness of breath. DCM often
represents the end stage of chronic ischemic heart disease in
patients who have experienced multiple heart attacks. Patient
prognosis depends on the stage of the disease but is characterized
by a high mortality rate. Other than heart transplant, there are no
effective long-term treatment options for end stage patients with
this disease. The New England Journal of Medicine estimates that in
the U.S. alone 120,000 people currently suffer from this disease;
other sources report estimates of up to 150,000. Scientific and
early clinical evidence suggest that high doses of stem and
progenitor cells may possibly slow down or reverse disease
progression in the heart of DCM patients. It is intended that
Aastrom's TRCs, a proprietary product containing large numbers of
stem and progenitor cells derived from a small sample of the
patient's own bone marrow, will be used as a therapeutic to induce
heart tissue regeneration in these patients. If successful, TRC
treatment may eliminate or delay the need for a heart transplant.
"We are pleased to receive an orphan drug designation from the FDA
for our TRC-based product as a potential new treatment option for
patients faced with this severe chronic heart disease," said George
Dunbar, Chief Executive Officer and President of Aastrom.
"Achieving this milestone is the first step in building the
foundation for our clinical program in cardiac regeneration. The
next anticipated milestone for our cardiac program is to initiate a
clinical trial that treats patients with dilated cardiomyopathy."
The orphan drug designation is granted to development-stage novel
therapeutics that offer potential value in the treatment of rare
diseases and medical conditions. Above and beyond assistance from
the Office of Orphan Products Development in furthering its TRC
tissue regeneration program, Aastrom may receive other benefits. In
particular, Aastrom may be entitled to an expedited FDA review, the
reduction or elimination of filing fees, and the availability of
possible tax credits. About Aastrom Biosciences, Inc. Aastrom
Biosciences, Inc. develops autologous cell products for the repair
or regeneration of multiple human tissues, based on its proprietary
Tissue Repair Cell (TRC) technology. Aastrom's TRC-based products
are a unique cell mixture containing stem and progenitor cell
populations, produced from a small amount of bone marrow taken from
the patient. TRC-based products have been used in over 230
patients, and are currently in clinical trials for bone
regeneration (osteonecrosis of the femoral head, long bone
fractures and spine fusion) and vascular regeneration (critical
limb ischemia) applications. Aastrom has reported positive interim
clinical trial results for TRCs suggesting both the clinical safety
and the ability of TRCs to promote healing in bone regeneration
applications. The Company is developing programs for TRC-based
therapies to address cardiac and neural regeneration indications.
TRCs have received Orphan Drug Designation from the FDA for use in
the treatment of osteonecrosis of the femoral head and dilated
cardiomyopathy. For more information, visit Aastrom's website at
http://www.aastrom.com/. (astmc) This document contains
forward-looking statements, including without limitation,
statements concerning the timing of planned clinical trials,
clinical trial strategies, product development objectives,
potential advantages of TRCs, and potential product applications,
which involve certain risks and uncertainties. The forward-looking
statements are also identified through use of the words "intended,"
"may," "possible," "potential," "should," and other words of
similar meaning. Actual results may differ significantly from the
expectations contained in the forward-looking statements. Among the
factors that may result in differences are potential patient
accrual difficulties, clinical trial results, potential product
development difficulties, the effects of competitive therapies,
regulatory approval requirements, the availability of financial and
other resources and the allocation of resources among different
potential uses. These and other significant factors are discussed
in greater detail in Aastrom's Annual Report on Form 10-K and other
filings with the Securities and Exchange Commission. CONTACTS: Kris
M. Maly Cameron Associates Investor Relations Department Kevin
McGrath Aastrom Biosciences, Inc. Phone: (212) 245-4577 Phone:
(734) 930-5777 Deanne Eagle (Media) Phone: (212) 554-546
http://www.newscom.com/cgi-bin/prnh/20070117/CLW099LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations Department, Aastrom
Biosciences, Inc., +1-734-930-5777; or Kevin McGrath of Cameron
Associates, +1-212-245-4577 or media, Deanne Eagle, +1-212-554-5463
Web site: http://www.aastrom.com/
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