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 S...( -Company Provides Update on Cash Posi...),Health

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EXTON, Pa., March 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy results from a Phase II/III clinical study (Study IT-A-008) of the Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. The study met all primary efficacy endpoints and was statistically significant, making this a major clinical milestone for the Company.

"This is very exciting, positive data which continues to support the potential of the Isolagen Therapy as a platform technology for aesthetic and therapeutic indications," said Declan Daly, President and Chief Executive Officer of Isolagen, Inc. "There is a great need globally for the treatment of acne scars and we believe that the Isolagen Therapy has a significant role to play in this largely untapped market."

The Phase II/III, placebo-controlled study investigating the efficacy and safety of Isolagen Therapy(TM) for the treatment of moderate to severe acne scars evaluated a total of 109 people at seven clinical sites across the United States. In the study, both the Patient and Evaluator assessments met the co-primary endpoints and were statistically significant, achieving p-values of 0.000011 and 0.016, respectively (p-values less than or equal to 0.05 are considered statistically significant).

With respect to the Patient assessments, 43 percent of patients reported a response to the Isolagen Therapy-treated side of the face, while 18 percent of patients reported a response on the placebo-treated side of the face. With respect to the Evaluator assessments, evaluators reported that 59 percent of patients responded on the Isolagen
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