Top-line efficacy and safety results from Phase 2b clinical trial of XIAFLEX announced

Dec 17 2009

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced top-line efficacy and safety results from a Phase 2b clinical trial of XIAFLEX(TM) for the treatment of Peyronie's disease. Peyronie's disease is characterized by the presence of inelastic collagen on the shaft of the penis, which can distort an erection and make sexual intercourse difficult or impossible in advanced cases. The Phase 2b study, conducted by the Company's partner, Auxilium Pharmaceuticals, Inc., was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients' sexual quality of life using the Peyronie's disease Patient Reported Outcome (PRO) questionnaire. Overall, XIAFLEX demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvatures disease bother domains disease trials with XIAFLEX, which included injection site bruising, edema and pain.

"Peyronie's disease can be psychologically devastating and patients have very limited and undesirable treatment options today," commented Thomas L. Wegman, President of BioSpecifics. "We look forward to progress in the clinical program for XIAFLEX in Peyronie's disease in 2010."

In patients who received XIAFLEX, a mean improvement of 29.7% in penile curvature from baseline to 36 weeks was seen (54.4 to 38.2) vs. an 11.0% mean improvement in curvature seen in placebo patients (50.6 to 45.1);s disease bother domain, the overall XIAFLEX treatment arm experienced a benefit in mean change in score from baseline to 36 weeks that was significantly better than the overall placebo arm benefit>

The Phase 2b study was a randomized, double-blind, placebo-controlled trial that was designed to assess the safety and efficacy of XIAFLEX when administered two times a week, every six weeks, for up to three treatment cycles (2 x 3). The study was conducted at 12 sites throughout the U.S., and 145 patients were monitored for 36 weeks following the first injection, with 109 patients receiving XIAFLEX as a series of intralesional injections and 36 receiving placebo (3:1 ratio) in the study. The treatment and placebo arms were also randomized to test for a benefit with the addition of penile modeling versus no modeling (1:1). Modeling refers to massaging of the plaque and is intended to maximize the enzymatic effect of the XIAFLEX injection in the plaque.

The trial was designed to measure the improvement in penile curvature and complete the validation of disease PRO, which measured four domains of patients' sexual quality of life over a period of 36 weeks: penile pain, Peyronie's disease bother, intercourse discomfort and intercourse constraint.

To qualify for the study, patients must have been diagnosed with Peyronie's disease for longer than six months, have stable disease, be able to maintain a rigid erection and have a penile contracture between 30 and 90 degrees. Patients were stratified by the degree of penile curvature (i.e. 30 degrees to 60 degrees versus 60 to 90 degrees).