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Millennium Announces First Clinical Data For TAK-700 Prostate Molecule at ASCO GU

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar 8, 2010 - Millennium: The Takeda Oncology Company today announced the presentation of safety, pharmacokinetic and efficacy data from the Phase I portion of a Phase I/II clinical trial evaluating TAK-700 in patients with metastatic castration resistant prostate cancer (mCRPC). These data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held March 5-7, 2010 in San Francisco, CA.

TAK-700, discovered by Takeda Pharmaceutical Company Limited, is an oral, selective, non-steroidal androgen synthesis inhibitor of the 17,20 lyase, which is a key enzyme in the production of steroidal hormones. Millennium initiated the Phase II portion of this trial in September 2009. Planning for Phase III studies is currently underway.

“This first presentation of TAK-700 clinical data represents a milestone for Millennium's prostate cancer portfolio,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “We are excited about this new class of therapy, are encouraged by these initial data, and are looking to the Phase II portion of this study to support the potential of TAK-700 in patients with castration resistant prostate cancer.”

Safety, pharmacokinetics, and efficacy of TAK-700 in metastatic castration-resistant prostate cancer: a phase 1/2, open-label study

In the Phase I portion of this trial evaluating 26 previously treated patients with mCRPC, researchers evaluated the safety and tolerability of oral TAK-700 given twice daily. Secondary objectives include assessment of efficacy, as shown by PSA response and reduction of hormone levels. Patients received one of five dose levels (100 mg – 600 mg) orally twice daily. One dose cohort did receive concomitant prednisone. Robert Dreicer, M.D., Cleveland Clinic, presented the following results:


  • All patients (n=15) who received TAK-700 ‰¥300mg orally twice daily for three or more cycles experienced a decrease in PSA levels
    • Within this patient group there was a decrease in testosterone to extremely low concentrations
  • Twenty-three (23) of the 26 patients experienced at least one drug-related treatment-emergent adverse event. The most common were fatigue, nausea, constipation, anorexia and vomiting
  • There were no dose limiting toxicities experienced during the Phase I portion of the trial

The Phase II portion of this study is ongoing and will further examine the safety and efficacy of TAK-700 and the need for concomitant prednisone.

About TAK-700

TAK-700, discovered by Takeda Pharmaceutical Company Limited, is an oral, selective non-steroidal androgen synthesis inhibitor of the 17,20 lyase enzyme, a key enzyme in the production of steroidal hormones. The 17,20 lyase enzyme is a key enzyme in the production of the common precursor molecules for male and female sex steroid hormones, which are synthesized in both the testes and the adrenal glands. This inhibitory activity makes TAK-700 a good candidate for development as a therapeutic agent for the treatment of castration-resistant prostate cancer where persistent extra-gonadal synthesis of androgens results in disease progression.

About Millennium

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. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website,

Editors' Note: This press release is also available under the Media section of the Company's website at:


Contact: Millennium Pharmaceuticals
Manisha Pai, 617-551-7877
Lauren Musto, 617-551-7848



Posted: March 2010

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