Auxilium Pharmaceuticals, Inc. announced that it has completed patient enrolment in the company's US phase IIb trial of Xiaflex for the treatment of Peyronie's disease.
In accordance with the study design, all enrolled patients have received their first injection of either Xiaflex or placebo. Due to the high level of interest from patients and physicians, the company exceeded its enrolment target of 120 patients.
"We are quite pleased to achieve this important development milestone in Peyronie's disease and advance what can potentially be a second indication for Xiaflex," said Armando Anido, chief executive officer and president of Auxilium. "We continue to believe that we will report top line results from the study in the fourth quarter 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 is being conducted at 12 sites throughout the US, and patients will be monitored for 36 weeks following the first injection.
The trial is designed to complete the validation of the company's 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. After validation, the company plans to use the PRO for its phase III Peyronie's disease trials, where it is intended to be used as the primary endpoint.
Xiaflex (clostridial collagenase for injection) is an investigational new drug that has completed phase III clinical trials for the treatment of Dupuytren's contracture, is in phase IIb of development for the treatment of Peyronie's disease and is in phase II of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). As an investigational non-surgical treatment for these conditions, Xiaflex is a combination of several subtypes of collagenase, derived from clostridium histolyticum, in specific proportion. Together, they work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase.
Peyronie's disease is the development of collagen plaque, or scar tissue, on the shaft of the penis that hardens and reduces flexibility, thus causing pain and forcing the penis to bend or arc during erection. This often can prevent sexual intercourse. In addition to difficulty with sexual intercourse, Peyronie's disease may also be associated with emotional distress, loss of self-esteem and depression. In certain populations, the estimated number of men affected by Peyronie's Disease may be as high as 9 per cent in men over 60 years of age and 3 percent in men over 30.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopaedists and select primary care physicians.