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.
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 aastrom.
(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.
Aastrom Biosciences, Inc.
aastrom