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October 30, 2006
Auxilium announced positive results from two phase II trials of AA4500 for the treatment of Peyronie's Disease. The primary endpoint for both trials was change from baseline in deviation of penile angle of at least 25%. Study A enrolled 25 subjects who received three injections of AA4500, each administered on a separate day, given over 7-10 days. A second series of three injections was administered 12 weeks later. Subjects were evaluated at three, six and nine months. At months three and six, 58% and 53% (respectively) of the subjects had reached the primary endpoint. At nine months post-last injection, the mean baseline deviation angle was 52.8 degrees. Study B enrolled 10 subjects who received three injections of AA4500, administered one per day, separated by at least one day each, over one week. Subjects then received a second series of 3 injections, each spaced 6 weeks apart. At nine months post-first injections, the mean baseline deviation angle was 50.2 degrees and 89% of the subjects had reached the primary endpoint. Auxilium plans to initiate a phase IIb trial of AA4500 in early 2007.