Capstone Therapeutics Announces Progress in Clinical Trials of AZX100 in Keloid Scarring

Capstone Therapeutics announced that participating patients have reached the planned 12-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 IIa clinical trials of AZX100 for the 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 12-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 patients were dosed in each of the keloid scarring trials. The Company is also conducting -- with similar outcome measures - a Phase IIa 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 patients who have undergone arthroscopic shoulder surgery. One hundred fifty patients were dosed in the trocar site scarring trial. Data from this study are due in the first quarter of 2011.