Isolagen, Inc, a specialty pharmaceutical company specializing in the development and commercialization of autologous (a patient's own) cellular therapy for hard and soft tissue regeneration (Isolagen Process), announced that the initial portion of its Phase III study is complete and the results indicate statistically that the therapy is both safe and effective. Early results show an efficacy of 77 per cent with the Isolagen treated group as compared to a 36 per cent response with the placebo-controlled group at this early time point. The Fisher's Exact Test confirms the statistical significance.

This study was conducted at ten sites and had an "intent to treat" population of 158 patients with an "evaluable" population of 146 patients. These patients were 90.5per cent female and 9.5per cent male with a mean age of 46.8 years old and a standard deviation of approximately 10 years. Over 91.8per cent of the treated population was Caucasian, 4.4per cent Asian, 1.9per cent Hispanic and 1.9per cent Black. The trial had a four month clinical end point with the physician photo guide assessment as the objective measure. To be categorized as a responder in the study, patients had to improve two or more points on a seven point scale. 77per cent of the patients treated with the Isolagen Process were responders.

"For this trial, we elected to examine the results at four months for comparison to other injectable treatments used for wrinkles and scars and we are very pleased with the data," said Vaughan Clift, medical director. "We have already published some of our international experience showing improvements with the Isolagen Process are better at six months and even greater at twelve months, leading us to believe that the strong results in this clinical trial represent early results which are likely to continue to improve over the next six months."

There was a minimal incidence of adverse events throughout the trial. Overall, less than 20per cent of patients had any adverse event that was possibly, probably, or definitely related to Isolagen therapy. The adverse events that did occur were bruising and/or edema at the injection site. There were no serious adverse events. Detailed analysis of the adverse events is continuing but were observed with both placebo and treated patients.

"We are very pleased with these results since we believe they strongly support the efficacy of the Isolagen Process," said Michael Macaluso, CEO and president. "The results from the trial position us well to move into the final phase of our clinical development process."

While there can be no assurances, the company anticipates that the Isolagen Process could be commercially available in the United States as early as 2005. Isolagen plans to initiate a confirmatory trial and will seek to establish a permanency designation.