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Medivation Announces New Positive Efficacy Data From Phase 1-2 Trial of MDV3100 in Castration-Resistant Prostate Cancer Patients
Date:2/25/2009

cell (CTC) counts, serum prostate specific antigen (PSA) levels, soft tissue and bony metastases, and time on treatment.

Almost all patients with favorable CTC counts (four or less) at the start of treatment maintained favorable counts at week 12 (89 percent of chemotherapy naive patients and 100 percent of post-chemotherapy patients). Importantly, a significant number of patients with unfavorable CTC counts of five or higher at baseline converted to favorable counts of less than five at week 12 (73 percent of chemotherapy naive patients and 40 percent of post-chemotherapy patients). This CTC conversion rate is encouraging in light of a recently published study in the October 2008 issue of Clinical Cancer Research, in which post-treatment conversion to a CTC count below five was associated with a 15-month survival benefit in castration-resistant prostate cancer patients.

MDV3100 also produced significant PSA declines (50 percent or more from baseline) and radiographic control (partial response or stable disease) in both chemotherapy naive and post-chemotherapy patients at week 12, as follows:

                       PSA response > 50%     Radiographic     Radiographic
                                             control: soft    control: bony
                                             tissue lesions     lesions
    Chemotherapy naive    57 percent           80 percent      61 percent
    Post-chemotherapy     45 percent           70 percent      64 percent

Thus far, the median time on treatment for chemotherapy-naive patients and post-chemotherapy patients is 276 and 145 days, respectively.

The new safety data include all 140 patients enrolled in the trial. MDV3100 has been generally well tolerated at doses of up to and including 240 mg/day. The most frequently reported adverse event was fatigue. Two witnessed seizures occurred in patients ta
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SOURCE Medivation, Inc.
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