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news.Takeda Pharmaceutical and Millennium, the Takeda Oncology Company have announced that Takeda Bio Development Center (Takeda Bio) has commenced patient enrollment for the two ongoing global Phase III clinical trials for the anti-prostate cancer investigational agent, Orteronel(TAK-700) in Japan.
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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 help produce 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.
Of the two, one trial (C21004) is a randomized, double-blind and multi-center trial of prednisolone plus orteronel or placebo in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).
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.