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Medivation Announces Presentation of Positive MDV3100 Clinical Data in Castration-Resistant Prostate Cancer Patients at 44th ASCO Annual Meeting
Date:6/2/2008

who have failed standard hormonal therapies. The dose-expansion study has enrolled 84 patients in three cohorts (60, 150, 240 mg/day) to date. Dr. Scher's presentation covered PSA data from all patients who have been followed for at least 12 weeks, the standard minimum duration of observation used to assess the treatment effects of prostate cancer drugs. Of the 42 chemo-naive and 31 post-chemotherapy evaluable patients across the three dose levels, 23 patients (55 percent) and 13 patients (42 percent) showed PSA declines greater than 50 percent at week 12 compared to baseline, respectively. Of the 28 evaluable patients from the 240 mg/day dose group of the trial, eight patients (29 percent) experienced a decline in PSA levels of greater than 90 percent compared to 9 percent and 13 percent in the 60 mg/day and 150 mg/day dose groups, respectively.

The number of CTC in a blood sample from a prostate cancer patient can indicate prognosis; patients with higher CTC counts (greater than or equal to five) are thought to have less favorable prognoses. MDV3100 treatment preserved favorable prognosis CTC counts below five in 92 percent of patients in the 60 and 150 mg/day dose groups and converted CTC counts from unfavorable to favorable prognoses in 33 percent of patients in the 60 mg/day dose group and in 56 percent of patients in the 150 mg/day dose group, respectively.

Importantly, radiographic data from both the 60 mg/day and 150 mg/day dosing cohorts showed stabilization of disease through 12 weeks of treatment. Of the 15 evaluable patients with soft tissue disease, 12 patients (80 percent) had stabilization of disease. Prior to enrollment in this study, all these patients had progressive disease despite standard-of-care hormonal therapies, and in roughly half the patients, also chemotherapy. As opposed to most previous studies in CRPC that have used the RECIST criteria to define evaluable patients and assess radiographic changes, the MDV3100 data were ana
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SOURCE Medivation, Inc.
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