Clinical Trials are ongoing at this time and participants are still able to enroll in the program. Click here to go to the Clinical Trial Website.
The first phase II trials, sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, with follow up and data analysis conducted by Auxilium, showed promising results. Both studies were open label and up to 12 months in duration. The trials were conducted to evaluate the efficacy and tolerability of Xiaflex in the treatment of Peyronie's disease. Clinical success was defined as change from baseline in deviation angle of at least 25%.
In Study A (n=25), three injections of Xiaflex, each administered on a separate day, were given over seven to ten days. Patients received a second series of three injections 12 weeks later. Patients were evaluated at three, six, and nine months post-last injection. The mean baseline deviation angle was 52.8°. With respect to deviation angle, clinical success was achieved at three and six months with 58% and 53% of patients, respectively.
The best results were achieved with a three-treatment series of three injections each in Study B (n=10). In Study B, patients received three injections of Xiaflex administered one per day, separated by at least one day each, over a one-week timeframe. Patients received two additional series of three injections, each spaced six weeks apart. The mean baseline deviation angle was 50.2°. At nine month follow up (post-first injections), 25% or greater reduction in deviation angle was achieved in eight out of nine patients who completed the study (89%, 1 patient had 24% reduction in deviation angle). Based on the investigator's global assessment, 67% of subjects were very much improved or much improved after treatment with Xiaflex.
The most common adverse events reported in both studies were local administration site reactions that were mild or moderate in severity, non-serious, and resolved in time without medical attention. Click here to go to the website: