"AA4500 is a non-surgical therapy that suggests effectiveness in treating Peyronie's disease," said Dr. Gerald Jordan, lead investigator and Professor of Department of Urology, Eastern Virginia Medical School. "The drug not only reduced penile curvature but also eliminated pain on erection and increased sexual enjoyment and satisfaction. As a result, physicians may be one step closer to being able to set a new expectation for the future treatment of this condition." Dr. Jordan presented the abstract at the western sectional AUA meeting and has been involved with the development and clinical trials of AA4500 in Peyronie's Disease.
Auxilium plans to initiate Phase IIb clinical trials for AA4500 in Peyronie's Disease in 2007. "We believe this is a significant milestone in the clinical development program for AA4500, which we also are developing for treatment of Dupuytren's Contracture and Frozen Shoulder Syndrome," said Armando Anido, Chief Executive Officer and President of Auxilium Pharmaceuticals. "Given the unmet medical need for patients with Peyronie's Disease, we are encouraged by these promising results and the potential benefit to patients who suffer from this condition."
Additional Information About Phase II Trials
Both studies were open label and up to 12 months in duration. They were conducted to evaluate the efficacy and tolerability of AA4500 in the treatment of Peyronie's disease. Clinical success was defined as change from baseline in deviation angle of at least 25 percent.
In Study A (n=25), 3 injections of AA4500, each administered on a separate day, were given over 7-10 days. Patients received a second series of 3 injections 12 weeks later. Patients were evaluated at three, six, and nine months post-last injection. The mean baseline deviation angle was 52.8 degrees. At months three and six, 58 percent and 53 percent of patients (respectively) achieved clinical success with respect to deviation angle.
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 AA4500 administered one per day, separated by at least one day each, over a one week timeframe. Patients received two additional series of 3 injections, each spaced 6 weeks apart. The mean baseline deviation angle was 50.2 degrees. At 9 month follow up (post-first injections), 25 percent or greater reduction in deviation angle was achieved in 8/9 patients who completed the study (89 percent, 1 patient had 24 percent reduction in deviation angle). Based on the investigator's global assessment, 67 percent of subjects were very much improved or much improved after treatment with AA4500.
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.
Next Steps in AA4500 Peyronie's Disease Clinical Trial Program
Auxilium plans to commence by the end of 2006 a pre-clinical animal study on the local effects and tolerability of AA4500 injected outside of the plaque. Auxilium expects to begin a Phase IIb dose optimization trial for Peyronie's Disease in 2007. An additional key element of this Phase IIb trial is validation of a patient questionnaire that will include data on the impact of AA4500 on improvement of sexual quality of life. These data will be used to support the primary efficacy endpoint in Phase IIb.
About Peyronie's Disease
Peyronie's Disease is the development of 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 intercourse. In addition to difficulty with sexual intercourse, Peyronie's Disease may also cause emotional distress such as 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 percent in men over 60 years of age and 3 percent in men over 30.(1)
About AA4500
AA4500 is an injectable enzyme with potential for multiple indications, including treatment of Peyronie's Disease, Dupuytren's Contracture and Frozen Shoulder Syndrome (Adhesive Capsulitis). AA4500 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for Peyronie's Disease and Dupuytren's Contracture. As previously stated, Auxilium plans to initiate a Phase IIb study for AA4500 for the treatment of Peyronie's Disease in 2007. In addition, Auxilium plans to initiate Phase III trials for AA4500 for the treatment of Dupuytren's Contracture in late 2006. Auxilium believes that AA4500 for the treatment of Frozen Shoulder Syndrome is in Phase II of development.
About Auxilium
(1) Wyllie, M.: Just Around the Corner: Effective Therapy for Peyronie's Disease?. B.J.U. Int., 98: 687-688, 2006. Safe Harbor Statement
In addition, forward-looking statements provide the Company's expectations, plans or forecasts of future events and views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward- looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this release.
Auxilium Pharmaceuticals, Inc.
