May 12 2010
Capstone Therapeutics (Nasdaq:CAPS) announced today it has completed a limited analysis of a subset of data from the second of its two ongoing AZX100 Phase 2a clinical trials in keloid scarring. The clinical trial will continue to its planned 12-month endpoints.
The company's goals for this analysis were to assess AZX100 ongoing safety, to evaluate the quality of the clinical trial dataset in order to guide future studies and to determine whether continuation of the trial would be futile from a statistical perspective.
"We have again met our objectives for this preliminary analysis of our second keloid trial," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "Following a limited review by our independent statistician of the safety and quality of the dataset, we have been advised to continue the trial. The primary endpoint is the 12-month POSAS score; we expect to report data from this trial during 4Q2010."
The two ongoing AZX100 Phase 2 keloid clinical trials (OL-ASCAR-04, dosing 3.0mg and 10.0mg per linear cm - continuation announced March 2, 2010; and OL-ASCAR-05, dosing 0.3mg and 1.0mg per linear cm – continuation announced today) are blinded, placebo-controlled, multicenter, parallel group dose ranging studies to evaluate the safety and preliminary efficacy of AZX100 following excision of keloid scars. The primary objective of the studies is to evaluate the efficacy of AZX100 based on the differences among dosage groups in Patient and Observer Scar Assessment Scale (POSAS) 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. Fifty-nine subjects were dosed in each trial. The analysis reported today examined certain metrics from a subset of dosed subjects followed for six months post-excision.
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