Medivation and Astellas Pharma have announced that they have treated the first patient in a Phase II study of MDV3100, a triple-acting oral androgen receptor antagonist to fight advanced prostate cancer.
The study is designed to compare MDV3100 with bicalutamide, a commonly used anti-androgen, and is expected to enrol approximately 370 patients in North America and Europe.
The primary endpoint of the trial is progression-free survival.
Astellas Pharma global development president Steven Ryder said this is the first of two Phase II trials that are being initiated to evaluate the potential benefit of MDV3100 in a broad spectrum of prostate cancer patients.
“The second of our new Phase II trials will study MDV3100 in an even earlier-stage population, and we expect to begin the trial in the first half of this year,” Ryder said.
MDV3100 is an investigational therapy for advanced prostate cancer, jointly developed by Medivation and Astellas.