Aastrom Biosciences Receives Orphan Drug Designation from the FDA for Proprietary Bone Marrow Cells
March 23 2006 - 3:00PM
PR Newswire (US)
-- Potential Treatment for Patients Suffering from Osteonecrosis of
the Hip; Major Cause of Hip Replacement -- ANN ARBOR, Mich., March
23 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM), announced today 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 osteonecrosis (also known as avascular necrosis). The
National Osteonecrosis Foundation indicates that in the U.S. alone,
there are at least 20,000 new people diagnosed with this
debilitating disease each year, and current therapies are of
limited effectiveness. (Logo:
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO )
Osteonecrosis is a painful medical condition where the tissue
inside a bone is dying and unable to regenerate itself through
natural processes. Ninety percent of the patients afflicted by this
disease have osteonecrosis at the hip, or more specifically the
femoral head -- the ball at the top of the femur bone that rotates
inside the hip socket. This disease usually attacks young male
adults, and left untreated the femoral head eventually collapses,
leading to the requirement of a total hip joint replacement. In the
U.S., it is estimated that up to 10% of all hip replacements are
performed due to osteonecrosis. There are no established
pharmaceuticals for the prevention or treatment of osteonecrosis.
The tissues destroyed in the osteonecrosis disease process include
bone, bone marrow and vascular (blood vessels). The diverse tissues
involved with this disease have complicated the development of
effective treatments in the past. Aastrom's TRCs, a proprietary
mixture of stem, stromal and progenitor cells derived from a small
sample of the patient's own bone marrow, have been used in clinical
trials to regenerate all three of these tissues. With this
capability, TRCs may offer a novel means to restore healthy tissue
at osteonecrotic sites. Aastrom is currently preparing a clinical
trial protocol to evaluate TRCs in the treatment of osteonecrosis
at the hip. In general terms, the expected treatment approach will
be to remove the necrotic tissue from the interior of the patient's
deteriorated bone, and implant the tissue-regenerating TRCs into
the femoral head. The expectation is that if the femoral head/hip
joint is strengthened by the re-growth of healthy bone, vascular
and marrow tissue, the need for a hip replacement could be delayed
or eliminated for patients suffering from this disease. "With our
clinical and developmental research progress using TRCs for the
regeneration of healthy bone, vascular and bone marrow tissues, we
can begin to target new areas of unmet medical need, such as
osteonecrosis," said R. Douglas Armstrong, Ph.D., Chairman and
Chief Executive Officer of Aastrom. "We are pleased to receive an
orphan drug designation for our TRC cell product as a new treatment
option for patients with such a significantly debilitating disease.
This progress is a part of our strategic plan for the development
of a new concept in products for use in complex orthopedic
indications." The orphan drug designation is granted to select
approaches that offer potential therapeutic value in the treatment
of rare diseases and conditions. Above and beyond assistance from
the Office of Orphan Products Development in furthering its TRC
tissue regeneration program, Aastrom may receive several other
benefits. In particular, Aastrom may be entitled to an expedited
FDA review, the reduction or even elimination of filing fees, and
the availability of possible tax credits. The Company will also be
entitled to marketing exclusivity for seven years once the product
receives FDA approval. About Aastrom Biosciences, Inc. Aastrom
Biosciences, Inc. (NASDAQ:ASTM) is developing products for the
repair or regeneration of multiple human tissues, based on its
proprietary Tissue Repair Cell (TRC) adult stem cell technology.
Aastrom's TRC products contain large numbers of stromal, stem and
progenitor cells that are produced from a small amount of bone
marrow cells originating from the patient. The AastromReplicell(R)
System, an industry-unique automated cell product manufacturing
platform, was developed for the production of standardized,
patient-specific TRC products. TRC products have been used safely
in humans as a substitute for bone marrow stem cells, and are
currently in clinical trials for bone grafting (long bone fractures
and spine fusion) and blood vessel regeneration (diabetic limb
ischemia) applications. The Company has recently reported positive
interim clinical trial results for its TRCs demonstrating both the
clinical safety and ability of TRCs to induce healthy new tissue
growth (long bone fractures and jaw bone reconstruction). For more
information, visit Aastrom's website at http://www.aastrom.com/.
This document contains forward-looking statements, including
without limitation, statements regarding product development
objectives and expected therapeutic value, potential benefits to be
received because of the orphan product classification, planned
clinical trials and their results, contemplated regulatory filings,
potential product applications and potential advantages of Tissue
Repair Cells (TRCs), which involve certain risks and uncertainties.
The forward-looking statements are also identified through use of
the words "plan," "may," "possible," "potential," "could,"
"expected," "expectation," 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 the results obtained from clinical
trial and development activities, regulatory approval requirements,
the availability of resources, competitive developments 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
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations Department of Aastrom
Biosciences, Inc., +1-734-930-5777; Kevin McGrath of Cameron
Associates for Aastrom Biosciences, Inc., +1-212-245-4577 Web site:
http://www.aastrom.com/
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