Aastrom's U.S. Clinical Investigator to Report Interim Data on Long Bone Fracture Repair Trial
February 14 2007 - 9:00AM
PR Newswire (US)
-- Additional Positive Patient Treatment Results Presented at the
American Academy of Orthopaedic Surgeons Meeting -- ANN ARBOR,
Mich., Feb. 14 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM), a company developing cell-based therapeutics for
regenerative medicine, today announced that 90% of the patients who
have completed the 12 months post-treatment follow-up in the
Company's U.S. Phase I/II multi-center clinical trial evaluating
the use of Tissue Repair Cells (TRCs) in the treatment of severe
long bone fractures had multiple bone bridges, evidence of bone
regeneration. Matthew L. Jimenez, M.D. of the Illinois Bone &
Joint Institute, Morton Grove, IL, and a Principal Investigator of
this clinical trial will present additional interim results from
patients treated with Aastrom's TRCs today at the American Academy
of Orthopaedic Surgeons (AAOS) annual meeting in San Diego, CA.
(Logo: http://www.newscom.com/cgi-bin/prnh/20070117/CLW099LOGO) All
36 patients enrolled and treated in this trial had severe long bone
non-union fractures that failed prior treatment interventions. The
patients were treated with TRCs -- a mixture of stem and progenitor
cells derived from the patient's bone marrow -- and will be
followed for a total of 12 months. Dr. Jimenez will present interim
clinical results from two groups of patients: 1) 20 who have
reached the 12 months post-TRC treatment endpoint, and 2) 31 who
have reached the 6 months observation endpoint post-TRC treatment.
To date, 20 of the 36 patients have completed the 12 months
post-treatment follow-up period. Of these 20 patients 18, or 90%,
have multiple bone bridges as observed in radiographs or computed
tomography. These interim results are consistent with the results
presented at the Annual Meeting of the American Society for Bone
and Mineral Research in September 2006. At that time, 12 patients
had completed the 12 months post-treatment follow-up period, and
83%, or 10 of the 12 patients, had multiple bone bridges. In
addition, at the AAOS meeting, Dr. Jimenez will also report that
early healing, or callus formation, was observed in 95%, or 19 of
the 20 patients who have reached the 12 months follow-up period. To
date, 31 patients have completed the 6 months post-treatment
follow-up period. Of these 31 patients 26, or 84%, have multiple
bone bridges as observed in radiographs or computed tomography.
Early healing, or callus formation, was observed in 97%, or 30 of
these 31 patients. Post-surgical evaluations of the patients using
standard clinical and radiographic evaluations of the healing
fracture site will continue through the end of June 2007. "I am
extremely encouraged by the results we have seen to date suggesting
TRCs enhance bone healing in atrophic non-union fractures,"
commented Dr. Jimenez. "This is an emerging therapy that appears
safe and efficacious, and I look forward to further exploring bone
regeneration with TRCs." "One of the most important pieces of
information we have derived from this study is that there were no
serious TRC-related adverse events observed in any of the
patients," stated Elmar R. Burchardt, M.D., Ph.D., Vice President,
Medical Affairs of Aastrom. "The results we have seen clearly
warrant further development of TRC-based therapeutics for
regenerative medicine." These patients all had fractures of their
tibia, femur or humerus bones which had failed to heal after one to
three (with an average of 1.75) prior standard of care bone
grafting and surgical treatments. Previous failed treatment
approaches include internal and external fixation to align and
immobilize the fractured bone, autologous bone grafting and bone
morphogenetic protein (BMP) supplementation. The TRC-treated
patients, aged 19-79 years, underwent open reduction and internal
fixation (ORIF) surgery in which TRCs were applied directly to the
fracture site, together with an allograft bone matrix graft
extender to promote local bone regeneration. This multi-center
trial treated patients at the following treatment centers: Lutheran
General Hospital, Park Ridge, IL; the University of Michigan Health
System, Ann Arbor, MI; William Beaumont Hospital, Royal Oak, MI;
and Lutheran Medical Center, Brooklyn, NY. 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 240 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
also 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 the treatment of dilated cardiomyopathy, a
severe chronic disease of the heart. 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 "appears,"
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) 554-5463
http://www.newscom.com/cgi-bin/prnh/20070117/CLW099LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations Department, of Aastrom
Biosciences, Inc., +1-734-930-5777, or Kevin McGrath,
+1-212-245-4577, or, media, Deanne Eagle, +1-212-554-5463, both of
Cameron Associates, for Aastrom Biosciences, Inc. Web site:
http://www.aastrom.com/
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