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news.Medivation, a biopharmaceutical company, has reported new data from an ongoing Phase I-II clinical trial demonstrating that the company's novel androgen receptor antagonist MDV3100 continues to show promising safety and efficacy results.
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The data showed encouraging and durable anti-tumor activity in the three expanded dose groups tested thus far, as measured by prostate specific antigen (PSA) declines, radiographic findings, circulating tumor cell (CTC) changes, and time on treatment. MDV3100 has been generally well tolerated, with no reports of serious adverse events deemed related to MDV3100. Dose escalation in the trial is continuing.
The ongoing Phase I-II trial is an open-label US dose-escalation study in prostate cancer patients who have failed standard hormonal therapies. To date, 120 patients have been enrolled in the trial with enrollment completed at doses up to 360mg/day. A total of 73 patients in the three lowest expanded dose groups (60, 150, and 240mg/day) have been followed for more than 24 weeks. Of these 73 patients, 31 patients (42%) have received MDV3100 for greater than 24 weeks.
At 12 weeks, the recommended time point for reporting PSA-based outcomes, 36 of 73 patients (49%) had a greater than 50% 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% of patients with evaluable soft tissue lesions in the 240mg/day cohort showing a partial response at 24 weeks.
The data suggest a dose-response trend with a higher percentage of patients in the 240mg/day dose cohort experiencing 90% reduction in PSA levels, radiographic partial responses and conversions to favorable CTC counts of less than five post-treatment. The company expects to seek FDA agreement to begin a pivotal Phase III registration study in castration-resistant prostate cancer patients in 2009.
Howard Scher, principal investigator of the trial, said: “The tolerability and the anti-tumor activity seen with MDV3100 after six months of treatment remains encouraging. The trial continues to enroll rapidly and additional data will further clarify the potential of MDV3100 as a treatment option for patients with castration-resistant prostate cancer, who have a poor prognosis and for whom treatment options are limited.”