Takeda's Anti-Prostate Cancer Agent Orteronel(TAK-700) Enters into Phase III Clinical Trials in Japan

01-30-2012: The Takeda Oncology Company (“Millennium”) announced that Takeda Bio Development Center Limited (“Takeda Bio”) has initiated enrollment of patients in Japan for the two ongoing global Phase III clinical trials for the anti-prostate cancer investigational agent, orteronel(TAK-700).

Orteronel, discovered by Takeda, is an oral, non-steroidal androgen synthesis inhibitor that has been shown in pre-clinical studies to selectively inhibit the 17, 20 lyase enzymes which are central to the production of steroidal androgens in the testes and adrenal glands.

The two trials are known as the ELM-PC (Evaluation of the Lyase inhibitor in Metastatic Prostate Cancer) trials. One of the trials (C21004) is a randomized, double-blind and multi-center trial of prednisolone plus orteronel or placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (“mCRPC”). The primary endpoints are Overall Survival (“OS”) and Progression Free Survival (“PFS”). The second (C21005) is a randomized, double-blind and multi-center trial of prednisolone plus TAK-700 or placebo in patients with mCRPC that have progressed during or following docetaxel-based therapy. The primary endpoint is OS.

“We are very pleased with the initiation of the Phase III clinical trials of orteronel in Japan,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “At present, mCRPC remains an incurable disease, and novel treatments are needed. We regard orteronel as one of our high-priority development programs, and will work to accelerate its development.”

“We expect orteronel has a potential to become a treatment option for prostate cancer with novel mechanism of action. We will strive to develop this drug as a new treatment to meet unmet medical needs,” said Hiroyasu Nakamura, President of Takeda Bio.