Capstone Therapeutics to continue AZX100 Phase 2a trial in dermal scarring to planned 12-month endpoints

Jul 7 2010

Capstone Therapeutics (Nasdaq:CAPS) announced today it has completed a limited analysis of a subset of data from its ongoing AZX100 Phase 2a clinical trial in trocar site scarring following arthroscopic shoulder surgery.  Based on this analysis, 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 met our objectives for this preliminary analysis of our trocar site scarring trial," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics.  "Following a limited review of the data by an independent statistician examining AZX100 safety and the quality of the dataset, we have been advised to continue the trial.  The primary endpoint is the 12-month POSAS score; secondary endpoints include a series of independently-analyzed, validated, objective measurements of the scar throughout the 12-month post-surgical period.  We expect to report data from this trial during 1Q2011."

Dermal scars result primarily from elective surgery (hospital and minor/office based), cosmetic, plastic and reconstructive surgery and trauma (including accidents, emergency and burns).  Scars - especially exuberant, hypertrophic scars - can cause debilitating aesthetic, functional and psychological effects and remain a significant area of unmet medical need. Market research indicates there may be as many as 22.5 million surgical procedures performed annually in the U.S. that could produce some form of scarring.  There are currently no prescription medications indicated for reduction of dermal scarring marketed in the U.S. or Europe.