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|Millennium and Takeda Announce Advancement of Prostate Cancer Program|
CAMBRIDGE, Mass., and Osaka, Japan, November 4, 2010 – Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced the initiation of a Phase III clinical trial for TAK-700 in the U.S. in patients with advanced prostate cancer. TAK-700 is a selective, oral, non-steroidal androgen synthesis inhibitor that in preclinical studies has been shown to selectively bind to and inhibit the enzyme 17,20 lyase in both the testes and adrenal glands.
This randomized, double-blind, multi-center, global2 Phase III study will examine TAK-700 with prednisone compared to placebo with prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) and has primary endpoints of Overall Survival (OS) and Progression Free Survival (PFS).
“Our hope is that this trial will demonstrate strong levels of efficacy that address the unmet medical needs in advanced prostate cancer,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “The progress of TAK-700 into Phase III study further demonstrates commitment of Millennium and Takeda to advancing the treatment of prostate cancer.
Millennium and Takeda anticipate to open enrollment of a second Phase III clinical trial2 of TAK-700 later this year. This second study will compare TAK-700 plus prednisone versus placebo plus prednisone in patients with mCRPC that have progressed during or following docetaxel-based therapy.
The 17, 20 lyase is a cytochrome P450 enzyme which cleaves steroid C17-C20 bonds to produce androgens.