Isolagen, Inc. (AMEX: ILE) has recently entered an agreement with the USFDA on the design of the company’s Phase III pivotal study protocol for the use of Isolagen™ Therapy for the treatment of wrinkles.
Isolagen’s protocol has been submitted to the USFDA under Special Protocol Assessment (SPA) regulations, which would allow the agency the evaluation of a clinical trial protocol that will form the basis of an efficacy claim for a marketing application.
According to Nicholas L. Teti, Isolagen Chairman and Chief Executive Officer:
"We are very pleased that the FDA has completed the SPA review process and agreed with our protocol design. We are eager to begin the Isolagen Therapy registration trials for the treatment of wrinkles and plan to begin enrolling patients as soon as possible. This is a key milestone for the Company. I applaud our clinical and regulatory team for this achievement."
The pivotal phase III trials are a randomized, double-blind studies designed to evaluate the efficacy and safety of Isolagen™ Therapy (IT) against placebo for the treatment of nasolabial skin fold wrinkles.
Source: Isolagen, Inc.
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