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Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars: Study Meets All Primary Efficacy Endpoints and is Statistically Significant
Date:3/5/2009

udy was to demonstrate the efficacy of three treatments of Isolagen Therapy on one side of the face as compared with placebo treatment on the other side of the face for the treatment of moderate to severe acne scars. The primary efficacy endpoints are measured four months following the last study treatment, using the following co-primary endpoints:

-- Patient Live Acne Scarring Assessment: The Patients' live assessment of the acne scarring of each cheek, using a 5point assessment scale, with a response defined as a 2-point improvement as compared to baseline, and an

-- Evaluator Live Acne Scar Assessment: The Evaluators' live assessment of the acne scarring of the treatment area on each cheek, using a 5-point assessment scale and photoguide, with a response defined as a 1-point improvement as compared to baseline.

Isolagen's Phase II/III study for moderate to severe acne scars was conducted under an FDA Investigational New Drug Application. Although statistically significant, these results do not guarantee approval of a commercial license or a labeling claim for this indication. The Company believes that to ultimately obtain FDA approval with respect to the acne scar indication, the Company will require FDA concurrence with the use of the Company's Evaluator Live Acne Scar Assessment scale, which the Company developed specifically for use in this study and which has not been previously used in a clinical trial. Further, if the Company obtains this concurrence from the FDA, then the Company will also require, at a minimum, one additional Phase III study to complement study IT-A-008 in order to pursue FDA approval and licensure.

Update Regarding Isolagen's Cash Position and the Biologics License Application for Wrinkles/Nasolabial Folds

Isolagen currently estimates that its unrestricted, available cash resources will allow the Company to continue in operation for approximat
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SOURCE Isolagen, Inc.
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