At 12 weeks, the recommended time point for reporting PSA-based outcomes, 36 of 73 patients (49 percent) had a greater than 50 percent decline in PSA compared to their baseline value. Patients also saw improvements as measured by radiographic changes and reductions in the number of CTCs to favorable counts, including 38 percent of patients with evaluable soft tissue lesions in the 240 mg/day cohort showing a partial response at 24 weeks. The data suggest a dose-response trend with a higher percentage of patients in the 240 mg/day dose cohort experiencing 90 percent reduction in PSA levels, radiographic partial responses and conversions to favorable CTC counts of less than five post-treatment.
"We are excited by the PSA decreases and radiographic findings observed with MDV3100 in the trial to date. Moreover, the positive shift observed in CTC counts and radiographic images suggests concordance of the data," said David Hung, M.D., president and chief executive officer of Medivation. "As the 240 mg/day dose has been well tolerated and appears to be the most effective, we are continuing to escalate the dose, with the 360 mg/day expansion group completely enrolled, dose escalation in progress at 480 mg/day, and initial dosing starting at 600 mg/day."
The Company expects to seek U.S. Food and Drug Administration agreement to begin a pivotal Phase 3 registration study in castration-resistant prostate cancer patients in 2009.
The data were presented today in a poster session at the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" in Geneva. Abstract no: 160.
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|SOURCE Medivation, Inc.|
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