Isolagen Modifies Ongoing Clinical Program for Acne Scars

Isolagen(TM), Inc. (Amex: ILE) announced today that the Food and Drug Administration (FDA) has provided follow-up on the Phase III program investigating the Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. The FDA reiterated that there are no safety issues that would prevent the initiation of the proposed studies.

However, the FDA asked the Company to further clarify certain protocol issues and raised questions related to the acne scar Evaluator Assessment Scale and Photo Guide. The FDA recommended that in order to address these issues, the Company should conduct a Phase II study; therefore, the Company will propose modifying the ongoing Phase III Study IT- A-008 as a Phase II/III study (as discussed further below). The FDA requests are specific to the acne scar clinical program and do not impact the Company's ongoing, pivotal Phase III clinical program evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles.

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