Takeda said that 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 lyase1 in both the testes and adrenal glands.
In the trial, the companies will examine TAK-700 with prednisone compared to placebo with prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) and has primary endpoints of Overall Survival (OS) and Progression Free Survival (PFS).
Millennium chief medical officer Nancy Simonian said that they hope this trial will demonstrate strong levels of efficacy that address the unmet medical needs in advanced prostate cancer.
"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.