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Prostate cancer kills more than 27,000 men each year in the U.S., making it the second leading cause of cancer death in men. Patients with castration-resistant prostate cancer (CRPC) have few treatment options and a poor prognosis.
Medivation is currently evaluating MDV3100 in an open-label Phase 1-2 clinical trial that will enroll approximately 100 patients with CRPC who have failed standard therapies. The study is currently planned to enroll patients in four dose-expansion cohorts and is being conducted at several clinical sites in the United States. Study endpoints include safety, tolerability, pharmacokinetics, effects on serum prostate-specific antigen (PSA) levels, a marker of tumor growth, and disease progression.
An increased number of androgen receptors present on prostate cancer cells is believed to play a major role in the growth of CRPC. Unlike currently available agents, MDV3100 has two modes of activity: (1) prevent the androgen receptor from entering the cell’s nucleus and triggering further growth of the tumor and, importantly, (2) continue to inhibit the growth of the cancer even when the androgen receptor is overexpressed, as is the case in CRPC.
Preliminary data presented in June 2008 at the American Society of Clinical Oncology 2008 Annual Meeting (ASCO) showed encouraging anti-tumor activity as measured by declining serum levels of PSA and circulating tumor cells (CTC), as well as radiographic disease stabilization, after three months of treatment. More than half of patients experienced PSA declines of greater than 50 percent at week 12 in the two highest dose levels enrolled to date (150 and 240 mg/day). The observed clinical effects of MDV3100 on PSA levels, CTC counts and radiographic disease are consistent with blockade of androgen receptor signaling and inhibition of tumor growth.
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