Safety Endpoint for TRC Product Reached - Trial Expanded

Related News: Bone and Cartilage

Aastrom Biosciences, Inc. (NASDAQ: 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.

Aastrom shares rose 27 cents, or 8 percent, to $3.64 in midday trading on the Nasdaq. The stock was trading at more than twice its average daily volume, making it one of the most-heavily traded small capitalization stocks at midday.


prnewswire.com



Posted on February 2, 2005 10:08 AM

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