Aastrom Biosciences Achieves Clinical Milestone in its Phase I/II U.S. Bone Grafting Trial

Aastrom Biosciences Achieves Clinical Milestone in its Phase I/II U.S. Bone Grafting Trial
PR Newswire
February 1, 2005
-- Safety Endpoint for TRC Product Reached; Trial Expanded --
ANN ARBOR, Mich., Feb. 1 /PRNewswire-FirstCall/ -- Aastrom Biosciences,
Inc. (NasdaqSC: ASTM) today announced that its U.S. clinical trial of the
Company's Tissue Repair Cell (TRC) product intended for the treatment of long-
bone, severe fractures has successfully achieved the first FDA-required
clinical benchmark, meeting the clinical safety endpoint for this product when
used in bone graft indications. The Company is now able to expand this trial
to include a broader range of fracture indications.
The first group of patients accrued into the trial suffered with long-term
(at least 8 months), non-union tibial fractures. With the safety milestone
achieved, the Company is permitted by the FDA-approved IND to now treat
appendicular, or fresh, non-union fractures, which opens the trial to a larger
patient population.
The sites engaged in this multi-center clinical trial are: Lutheran
General Hospital in Park Ridge, IL, the University of Michigan Health System's
Orthopedic Trauma Center, Ann Arbor, MI and the Department of Orthopedic
Surgery at William Beaumont Hospital in Royal Oak, MI. The Company
anticipates adding additional sites to this U.S. trial. The safety benchmark
was achieved in the patient group accrued at Lutheran General Hospital,
supplemented with the initial results from the Company's trial of this same
product in Barcelona, Spain.
"We are progressively building the clinical foundation for the safety and
usefulness of our Tissue Repair Cell technology for bone regeneration," said
R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman of Aastrom.
"The expansion of this trial to include patients with fresh non-union
fractures should accelerate accruals into our bone graft study."
Aastrom's bone graft TRC product is also in clinical trials in Barcelona,
Spain and Bochum, Germany. In October 2004, the Company announced initial
results of, and the decision to expand the Barcelona bone graft trial. In
addition, the Company is currently engaged in a clinical trial in Barcelona
for the use of TRCs in sinus lift procedures, and in 2005 the Company intends
to initiate a clinical trial of its TRC product for the treatment of limb
ischemia in diabetic patients in Germany. The Company is in the process of
preparing an IND application to be filed with the FDA for its TRC product
intended for use in spine fusions.
About Aastrom's TRCs
Tissue Repair Cells (TRCs) are Aastrom's proprietary mixture of adult bone
marrow stem and progenitor cells produced using patented single-pass perfusion
technology in the AastromReplicell(R) System. The clinical procedure begins
with the collection of a small sample of bone marrow from the patient's hip in
an outpatient setting. TRCs are then produced in the automated
AastromReplicell System over a 12-day period. It has been demonstrated in the
laboratory that TRCs are able to develop into different types of tissue
lineages in response to inductive signals, including blood, bone, cartilage,
adipose and vascular tubules. In previous clinical trials, TRCs have been
shown to be safe and reliable in regenerating certain normal healthy bone
marrow tissues.
About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is developing treatments for
the repair of damaged human tissues and other medical disorders, or the
generation of normal human tissues, utilizing the Company's proprietary adult
stem cell-based products. Aastrom's strategic position in the tissue
regeneration and cell therapy sectors is enabled by its proprietary Tissue
Repair Cells (TRCs), a mix of bone marrow stem and progenitor cells, and the
AastromReplicell(R) System, an industry-unique automated cell production
platform used to produce cells for clinical use. Together TRCs and the
AastromReplicell System provide a foundation that the Company is leveraging to
produce multiple Prescription Cell Products (PCPs), several of which are now
in the clinical stage in the U.S. and EU. TRCs are the core component of the
PCPs Aastrom is developing for bone grafting, peripheral vascular disease, jaw
bone reconstruction and spine fusion markets. The Company has also developed
the AastromReplicell System for dendritic cell production for researchers and
institutions developing vaccines to treat cancer and infectious diseases,
under its Cell Production Products line.
For more information, visit Aastrom's website at http://www.aastrom.com.
This document contains forward-looking statements, including without
limitation, statements concerning planned clinical trials, product development
objective, and potential product applications, which involve certain risks and
uncertainties. The forward-looking statements are also identified through use
of the words "intended," "should," "anticipates," 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 future clinical trial results, regulatory approval
requirements, the availability of 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 or Becky Anderson Kevin McGrath
Investor Relations Department Cameron Associates
Aastrom Biosciences, Inc. Phone: (212) 245-4577
Phone: (734) 930-5777