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Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant
Date:8/5/2008

mparable to p values at Month 2, with both observation periods achieving statistical significance.
Top-line Statistical Results at Observation Visits (p values*):

005 Patient 005 Evaluator 006 Patient 006 Evaluator

Month 2 0.0001 0.0005 0.0003 0.0039

Month 4 0.0006 0.0003 0.0012 0.0002

Month 6 0.0001 <0.0001 <0.0001 0.0075

*p values greater than or equal to 0.05 are considered statistically significant.

Preliminary safety analyses showed the Isolagen Therapy was well tolerated with safety results comparable to placebo in the clinical studies. No serious adverse events related to Isolagen Therapy were observed in the studies.

"I am excited by these positive study results suggesting a clinical benefit from the Isolagen Therapy, a novel therapy using a person's own cells for the treatment of wrinkles," said Stacy R. Smith, M.D., study investigator and Assistant Clinical Professor, Division of Dermatology, University of California San Diego. "I believe the aesthetics community would welcome a new, first in class, regenerative therapy. The results of these pivotal studies will generate even greater interest in the outcome of the ongoing Phase II/III clinical study of Isolagen Therapy for the treatment of acne scars, where there is a significant unmet need."

The Isolagen Process(TM) is a proprietary cellular processing system that creates a natural, living cell therapy. By multiplying a person's own collagen-producing cells, or fibroblasts, into tens of millions of new cells, a personalized treatment is created that is then returned to the person's skin. This first of its kind aesthetic treatment, known as the Isolagen Therapy, is designed to improve skin damage caused by the normal effects of aging, sun damage, acne and burns.

"We are thrilled with the positive results fr
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SOURCE Isolagen, Inc.
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