Aastrom Biosciences Reports Interim Data from Long Bone Non-Union Fracture Clinical Trial
16 September 2006 - 4:00AM
PR Newswire (US)
Promising Results Demonstrated in Patients ANN ARBOR, Mich., Sept.
15 /PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc.
(NASDAQ:ASTM) today reported additional interim results from
patients enrolled in its U.S. Phase I/II multi-center clinical
trial evaluating Tissue Repair Cells (TRCs) in the treatment of
recalcitrant long bone non-union fractures. Of the 36 patients
enrolled in the FDA-approved trial, interim results were reported
on 23 patients, including 12 patients who completed the total trial
observation period of 12 months by August 2006. Of the 12 patients
who have completed the one year follow-up period, 10 showed bone
bridging at the fracture site, indicating radiographic evidence of
healing. (Logo:
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO ) At this
time, two subsets of patients totaling 15 have completed clinical
examination surveys with their doctors. In the first sub-group, 6
out of 7 patients have returned to weight bearing mobility by 6
months. In the second sub-group, 8 out of 8 patients have returned
to weight bearing mobility by 12 months. Callus formation is the
first sign of healing and return of blood flow. After being treated
with Aastrom's TRC-based cell product, callus formation was
observed in 78% of the 23 patients by 3 months, and in 96% of these
patients by 6 months. All 23 patients had atrophic non-union
fractures of a long bone (leg or arm), which had failed to heal
after prior standard of care bone grafting and surgical treatments,
and consequently, were considered very difficult to treat; 10 of
the patients had failed two to three prior treatments. Of the
patients reported to date, 10 of the patients were smokers, who
have a particularly poor prognosis for healing. The results were
presented by one of the Principal Investigators, Thomas R. Lyon,
M.D., Chief of Orthopedic Trauma & Clinical Instructor of
Orthopedic Surgery at Lutheran Medical Center, in Brooklyn, New
York, and Janet M. Hock, B.D.S., Ph.D., Vice President Global
Research and Chief Scientific Officer of Aastrom, today as part of
a media briefing at the 28th Annual Meeting of the American Society
for Bone and Mineral Research (ASBMR) in Philadelphia, PA. Dr. Lyon
and Dr. Hock will also host the poster during this afternoon's
Plenary Session. This announcement follows positive interim data
presented earlier this year by Principal Investigator, Matthew L.
Jimenez, M.D., of the Illinois Bone & Joint Institute as part
of a symposium at the combined Orthopaedic Research Society and
American Academy of Orthopaedic Surgeons meetings in Chicago, IL.
Dr. Jimenez presented results from his early clinical experience
with the first seven patients, all of whom demonstrated bone
healing after TRC therapy, and returned to weight bearing mobility
by 6 months. Aastrom will also be represented at the ASBMR meeting
by Dezhong Yin, Ph.D., who was chosen to receive one of the
society's prestigious Young Investigator Awards. ASBMR Young
Investigator Awards recognize young investigators for their
excellence in the field of bone and mineral research. In addition
to being chosen for this award, Dr. Yin will give an oral
presentation entitled, "Efficient Tracking of the Fate of Human
Bone Marrow Stem Cells for Bone Regeneration Using a Bone-Specific
Promoter Driving GFP within a Lentiviral Vector," on Saturday,
September 16th. Other Aastrom scientists presenting posters at the
meeting on Monday, September 18th, are Kristin Goltry, Ph.D. and
Jon Rowley, Ph.D. Dr. Goltry's poster is entitled, "Enhancing the
Osteogenic Potential of Bone Marrow-Derived Progenitor Cells in
Primary Culture." Dr. Rowley's poster is entitled, "In Vitro
Characterization of Adult Stem Cells Formulated with
beta-Tricalcium Phosphate Matrix for Bone Regeneration." About
Aastrom Biosciences, Inc. Aastrom Biosciences, Inc. (NASDAQ:ASTM)
is developing 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 stromal, stem and progenitor
cell populations, produced outside the body from a small amount of
bone marrow taken from the patient. TRC-based products have been
used in over 225 patients, and are currently in clinical trials for
bone regeneration (long bone fractures and spine fusion) and
vascular regeneration (critical limb ischemia) applications. The
Company has reported positive interim clinical trial results for
TRCs suggesting both the clinical safety and the ability of TRCs to
induce tissue regeneration in long bone fractures and jaw bone
reconstruction. Recently, the Company's proprietary TRCs received
an Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for use in the treatment of osteonecrosis of
the femoral head. In addition, Aastrom is developing plans for a
TRC-based therapy for cardiac regeneration. For more information,
visit Aastrom's website at http://www.aastrom.com/ . This document
contains forward-looking statements, including without limitation,
statements concerning product development objectives, planned
clinical trials and potential product applications, which involve
certain risks and uncertainties. The forward-looking statements are
also identified through use of the words "plans," 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 product
development difficulties, clinical trial results, potential patient
accrual 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/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; or Kevin McGrath,
+1-212-245-4577, or Deanne Eagle (Media), +1-212-554-5463, both of
Cameron Associates Web site: http://www.aastrom.com/
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