ILE Isolagen

- Significant Improvements Reported Over Placebo Across All Study Endpoints; Effects of Therapy Observed to Build Over Time - EXTON, Pa., Oct. 22 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (AMEX:ILE) presented today an analysis of results from the completed pivotal Phase III studies (Studies IT-R-005 and IT-R-006) of the Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles. Both studies, conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA), reported statistically significant results meeting all primary endpoints. The analysis was presented today in a company webcast. Please visit http://www.isolagen.com/ for the complete audio and slide presentation. "The full analysis of data from these pivotal safety and efficacy studies is very exciting and further supports the potential of Isolagen Therapy as an innovative treatment for wrinkles. In addition to improving the appearance of wrinkles, the effects of Isolagen Therapy in the studies were observed to build over time, which may allow for gradual rejuvenation of the skin," said Stacy R. Smith, M.D., study investigator and Assistant Clinical Professor, Division of Dermatology, University of California San Diego. "There is a growing demand for minimally invasive procedures that rejuvenate the skin." The Isolagen Process(TM) is a proprietary cellular processing system that creates a natural, living cell therapy. By multiplying a person's own collagen-producing cells, or fibroblasts, into tens of millions of new cells, a personalized treatment is created that is then returned to the person's skin. This first-of-its-kind aesthetic treatment, known as Isolagen Therapy, is designed to improve skin damage caused by the normal effects of aging, sun damage, acne and burns. "We are very pleased with the analysis of our Phase III pivotal studies, which highlights the potential of Isolagen Therapy to provide a unique treatment paradigm in the field of medical aesthetics," said Declan Daly, President and Chief Executive Officer of Isolagen. "These significant results from our pivotal wrinkle trials confirm our belief that Isolagen Therapy has the potential to become the first ever autologous cell therapy product to treat wrinkles, and may one day be positioned similarly for additional clinical applications including acne scars and burn scars." Study 005 and 006 Data Analysis Highlights 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. Results from both studies were statistically significant for the co-primary endpoints assessed at Visit 6. In Study IT-R-005, both the Evaluator and Patient evaluations met the co- primary endpoints and were statistically significant, achieving p values of