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.
TAK-700, discovered by Takeda Pharmaceutical Company Limited, is an oral, non-steroidal androgen synthesis inhibitor that selectively inhibits the 17,20 lyase enzyme. This enzyme, which is present in both the testes and adrenal glands, is central to the production of steroidal androgens. Synthesis of androgens outside the testes contributes to disease progression in castration-resistant prostate cancer (CRPC). Therefore, TAK-700 is a good candidate for development as a therapeutic agent in this disease setting.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. ("Takeda", TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
Manisha Pai Lauren Musto
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The 17, 20 lyase is a cytochrome P450 enzyme which cleaves steroid C17-C20 bonds to produce androgens.
2 Trial locations is the U.S. at the beginning and the enrollment in Asia including Japan, Europe, and Latin America is planned.