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 S...( Investor Conference Call to be held...),Health

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EXTON, Pa., Aug. 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy and safety results from two pivotal, Phase III clinical studies (Studies IT-R-005 and IT-R-006) of the Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles. Each study, conducted under an FDA Special Protocol Assessment (SPA), met all primary endpoints and was highly statistically significant, making this a major clinical milestone for the Company.

"This is a significant achievement for Isolagen and an important step towards bringing the first ever autologous cell therapy product to the market for aesthetic use. As the future evolves and current therapies continue to show their age, the need for novel skin rejuvenation products becomes evident. With these statistically significant results, we believe we are now in an excellent strategic position," said Nicholas L. Teti, Jr., Chairman of Isolagen. "These results further support the proof of principle for autologous cell therapy and open the door for further research in aesthetics, acne scars, burn scars and other clinical applications."

The pivotal, Phase III placebo-controlled studies investigating the efficacy and safety of Isolagen Therapy for the treatment of nasolabial folds, or wrinkles, evaluated a total of 421 people at 13 clinical sites across the United States. In Study IT-R-005, both the Evaluator and Patient evaluations met the co-primary endpoints and were statistically significant achieving p values of <0.0001 and 0.0001, respectively. In Study IT-R-006, statistical significance was also achieved for both primary efficacy endpoints, achieving p values of 0.0075 and <0.0001 for the Evaluator and Patient evaluations, respectively.

Top-line statistical results showed that p values at Month 6 following third injection were co
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