BioSpecifics Technologies Corp. Announces Initiation of Phase IIb Trial for Peyronie...( LYNBROOK N.Y. Sept. 17 /- BioSpec...),Health

LYNBROOK, N.Y. Sept. 17 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (OTC Bulletin Board: BSTC), a biopharmaceutical company developing first in class collagenase based products, announced today the initiation of a U.S. Phase IIb clinical trial in Peyronie's disease for its injectable collagenase, XIAFLEX (TM), by its partner Auxlium Pharmaceuticals, Inc.

"We are very pleased that our partner has chosen to advance this trial into a Phase IIb based on our extremely encouraging IIa results that showed a statistically significant reduction of angle of penile curvature and improvement in sexual satisfaction," stated Thomas Wegman, President of BioSpecifics Technologies Corp. "Peyronie's disease affects over 1 million men worldwide and there are no currently effective pharmaceutical therapies. We are happy to be one step closer to making this minimally invasive therapy available for those that need it and we look forward to the anticipated trial results that will be announced by the end of 2009."

The Phase IIb study is a randomized, double-blind, placebo-controlled study that is 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), in subjects with Peyronie's disease. The study will involve at least 120 patients at approximately 11 sites throughout the U.S., and patients will be monitored for 36 weeks following the first injection.

The trial is also designed to validate a proprietary Peyronie's Patient Reported Outcome (PRO) questionnaire, which will measure several domains of patients' sexual quality of life, over a 36 week period. The four domains measured by the PRO are penile pain, Peyronie's disease bother, intercourse discomfort and intercourse constraint.

To qualify for the study, patients must be able to maintain a rigid erection and have a penile contracture between 30 and 90 degrees. Patients will be stratified by the deg
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