Isolagen Modifies Ongoing Acne Scars Clinical Program

The FDA has asked Pennsylvania-based biotech Isolagen to further clarify certain protocol issues regarding its acne scar treatment trials.

Isolagen said that the FDA has raised questions related to the acne scar evaluator assessment scale and photo guide. The FDA recommended the company to conduct a Phase II study in order to address these issues. These FDA requests are specific to the acne scar clinical program and do not impact the company’s other ongoing programs, the company added.

Isolagen’s two randomized, double-blind, placebo-controlled acne scar clinical trials (ITA-008 and IT-A-009) of approximately 120 patients each were 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.

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.

Nicholas Teti, Jr., chairman and CEO of Isolagen, said: “We appreciate the FDA’s attention and guidance and are moving forward to modify our acne scar clinical program. 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.”