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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

om our pivotal Phase III clinical studies of the Isolagen Therapy," said Declan Daly, President and Chief Executive Officer of Isolagen. "We intend to file our Biologics License Application (BLA) with the FDA in early 2009 and continue to progress our ongoing Acne trial. I want to thank the clinical investigators and congratulate the Isolagen team for their exceptional performance and clinical achievement in this groundbreaking pivotal study confirming our belief in this innovative approach to aesthetic skin therapy."

About the Studies

The goal of the Phase III multicenter, double-blind, randomized, placebo- controlled studies was to demonstrate the efficacy of three treatments of Isolagen Therapy compared with placebo in the treatment of bilateral nasolabial folds, or wrinkles, six months following the last study treatment, using the co-primary endpoints of:

-- Subject Wrinkle Satisfaction Assessment: the person's own assessment of the wrinkles using a 5-point wrinkle satisfaction scale, and an

-- Evaluator Wrinkle Severity Assessment: the evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using a 6-point ordinal wrinkle severity scale with a photoguide as a reference tool.

Isolagen's Phase III studies for wrinkles were conducted under the Food and Drug Administration's (FDA) Special Protocol Assessment (SPA) regulations. The SPA process results in an agreement with the FDA that successful clinical trial results will form the basis of an efficacy claim for a marketing application. Although significant, the SPA does not guarantee approval of a BLA.

Further, Isolagen is currently conducting a Phase II/III clinical program to investigate the Isolagen Therapy for the treatment of moderate to severe acne scars.

Investor Conference Call

Isolagen will be hosting an investor conference call and webcast on Wednesday, August 6, 2008 at 8:00 a.m. Eastern Time to discuss the results of t
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SOURCE Isolagen, Inc.
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