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| |  AUA MEETING: Duros Implant Suppresses Testosterone In Men With Prostate Cancer SAN DIEGO, CA -- June 4, 1998 -- A drug-filled titanium implant, placed just under the skin of a patient's arm, effectively suppressed testosterone to therapeutically-desirable levels for up to 10 months in men with advanced prostate cancer, according to results of a Phase I/II clinical trial presented at the 93rd annual meeting of the American Urological Association. The clinical study evaluated the safety, efficacy and dose of the first product incorporating Alza Corp.’s Duros(TM) implant technology, which is designed to deliver leuprolide continuously for up to12 months as a palliative therapy for advanced prostate cancer. In the Phase I/II dose-ranging study, 51 patients with advanced prostate cancer were randomised to receive either one or two Duros leuprolide implants. All patients in both groups achieved therapeutic suppression of testosterone levels, as measured monthly through blood samples. The safety profile of Duros leuprolide was consistent with androgen deprivation therapy. "Continuous, uninterrupted drug administration is essential to the success of testosterone suppression therapy in the treatment of advanced prostate cancer," said Jackson Fowler, Jr., M.D., professor of surgery and chief of urology at the University of Mississippi Medical Center. "The results of this study indicate that therapy with the Duros leuprolide product may be a viable alternative to more frequent injections. It's also significant to note that patients were able to maintain active lifestyles without discomfort from the implant." Implantation of the Duros systems in the study was well accepted by both the patients and the investigating clinicians. Patients in the study rated the titanium implants as very comfortable in monthly questionnaires. The Duros implant is an osmotically-driven, miniature pump that is inserted under the skin using a local anesthetic in an outpatient setting. The implant, which is about the size of a matchstick, is designed to allow for continuous, steady-state delivery of a drug for up to 12 months. Testosterone suppression is required in the treatment of prostate cancer because the presence of the hormone fuels the growth of cancerous cells. To date, suppression of testosterone levels has typically been achieved through orchiectomy (surgical removal of the testicles), daily subcutaneous injections or intramuscular depot injections administered once every one, three or four months. Leuprolide is well established as a palliative treatment for advanced prostate cancer.
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