Capstone Therapeutics announced the completion of enrolment for its AZX100 phase 2 clinical trial in dermal scarring following shoulder surgery.
The clinical trial is a phase 2a double blind, placebo controlled, multi-centre 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 (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. One-hundred fifty (150) patients are now enrolled in the trial.
AZX100 is a novel synthetic 24-amino acid peptide, one of a new class of compounds in the field of smooth muscle relaxation and fibrosis. Based on its demonstrated effects in pre-clinical models and safety in clinical trials, AZX100 is currently being evaluated for commercially significant medical applications such as the prevention or reduction of hypertrophic and keloid scarring, treatment of pulmonary disease and intimal hyperplasia. Capstone has an exclusive worldwide license to AZX100.
"We are pleased that enrolment is complete in the AZX100 Phase 2 clinical trial programme in dermal scarring following shoulder surgery," said Randolph C. Steer, MD, Ph.D., president of Capstone Therapeutics. "We met our target enrolment numbers for the trial, marking another development milestone for Capstone Therapeutics. With the previously-announced completion of enrolment for our phase 2 studies in keloid scarring, we remain on track with our timelines for 2010."
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 US that could produce some form of scarring. There are currently no prescription medications indicated for reduction of dermal scarring marketed in the US or Europe.
Capstone Therapeutics is a biotechnology company committed to developing a pipeline of novel therapeutic peptides aimed at helping patients with under-served medical conditions.