Each study, conducted under an FDA special protocol assessment, met all primary endpoints and showed statistically significant results.
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 US.
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 sixth month following third injection were comparable to p values at second month, with both observation periods achieving statistical significance. Preliminary safety analyses also showed the Isolagen therapy was well tolerated with safety results comparable to placebo in the clinical studies. Declan Daly, president and CEO of Isolagen, said: "We are thrilled with the positive results from our pivotal Phase III clinical studies of the Isolagen Therapy. We intend to file our biologics license application with the FDA in early 2009 and continue to progress our ongoing acne trial."