Capstone Therapeutics initiates dosing in Phase II dermal scarring trial

The clinical trial is a Phase IIa double blind, placebo controlled, multi-center dose ranging study to evaluate the safety and preliminary efficacy of AZX100 in trocar sites of arthroscopic shoulder surgery patients.

The primary objective is to evaluate the efficacy of AZX100 based on the differences among three dosage groups in patient and observer scar assessment scale scores at 12 months.

Secondary objectives include safety determination and evaluations of efficacy via validated scar assessment scales using both 2D and 3D digital photography. Approximately 150 patients are planned for treatment. An interim analysis is scheduled for late fourth quarter 2009.

Randolph Steer, president of Capstone, said: “We are pleased that dosing has begun in the AZX100 Phase II clinical trial program in dermal scarring. Initiating the Phase II trial of AZX100 marks another development milestone for Capstone Therapeutics. We had previously stated this study would begin during first quarter 2009, and we remain on track with our timelines.”