FDA has provided follow-up on the Phase III program investigating Isolagen's Therapy for the treatment of moderate to severe acne scars. The FDA reiterated that there are no safety issues that would prevent the initiation of the proposed studies.
However, the FDA asked the Company to further clarify certain protocol issues and raised questions related to the acne scar Evaluator Assessment Scale and Photo Guide. The FDA recommended that in order to address these issues, the Company should conduct a Phase II study; therefore, the Company will propose modifying the ongoing Phase III Study IT- A-008 as a Phase II/III study (as discussed further below). The FDA requests are specific to the acne scar clinical program and do not impact the Company's ongoing, pivotal Phase III clinical program evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles.
Isolagen's two randomized, double-blind, placebo-controlled acne scar clinical trials (IT-A-008 and IT-A-009) of approximately 120 patients eachwere designed and powered as Phase III studies. Based on this additional information from the FDA, Isolagen will propose to modify the initiated study IT-A-008 to be a Phase II/III study. This study, which is designed to demonstrate efficacy, will be amended to allow for a closer assessment of the Evaluator Assessment Scale and Photo Guide. Based on the study's findings, the Company will propose to continue with the acne scar pivotal clinical program during 2008. Isolagen believes that the two trials may have the potential to form the basis of a Phase III trial submission to the FDA.
"We appreciate the FDA's attention and guidance and are moving forward to modify our acne scar clinical program," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Isolagen. "Little scientific research has been done previously to establish clinical efficacy measurements in the area of acne scarring. We feel it is important to advance our technology in a new therapeutic category for this unmet need, and we will continue to collaborate with the FDA to move our program forward."