Capstone Therapeutics reaches overall progress in AZX100 Phase 2a clinical trials for keloid scarring

Capstone Therapeutics (Nasdaq:CAPS) (the "Company") announced today that participating subjects have reached the planned twelve-month timepoint in the first of its two ongoing AZX100 Phase 2a clinical trials in keloid scarring. Data analysis for these subjects is underway.  Per protocol and the original clinical development plan, results of the two keloid scarring trials will be pooled for analytical purposes and are scheduled for release during 4Q2010.

Capstone is conducting two Phase 2a clinical trials of AZX100 in reduction or prevention of keloid excisional scarring: OL-ASCAR-04, with dosing at 3.0 mg and 10.0 mg per linear cm (cohort completion to twelve-month timepoint announced today); and OL-ASCAR-05, with dosing at 0.3 mg and 1.0 mg per linear cm (trial continuing to its planned 12-month timepoint). These are blinded, placebo-controlled, multicenter, parallel group dose ranging studies to evaluate the safety and preliminary efficacy of AZX100 following excision of keloid scars. Endpoints of these studies include objective evaluations of safety and efficacy of AZX100 based on validated scar assessment scales as well as blinded independent clinical evaluations using high-resolution 3D digital photography. Fifty-nine subjects were dosed in each of the keloid scarring trials.

"We are pleased with our overall progress and with the low attrition rates in the clinical trials of AZX100 in keloid scarring," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "We designed these trials to guide and inform the clinical development of AZX100 in this challenging keloid scarring indication. As previously announced, we expect to report data from this set of trials during 4Q2010."

The Company is also conducting – with similar outcome measures - a Phase 2a clinical trial of AZX100 in trocar site scarring (OL-ASCAR-03); this is a double-blind, placebo within-patient controlled, multi-center dose ranging study to evaluate the safety and preliminary efficacy of AZX100 in trocar site scars of subjects who have undergone arthroscopic shoulder surgery. One hundred fifty subjects were dosed in the trocar site scarring trial. Data from this study are due 1Q2011.