Takeda Presents First Clinical Data For TAK-700 Prostate Molecule

The 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, 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.

In the Phase I portion of the 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.

In the trial, the patients received one of five dose levels (100mg – 600mg) orally twice daily. One dose cohort did receive concomitant prednisone. All patients (n=15) who received TAK-700 =300mg orally twice daily for three or more cycles experienced a decrease in PSA levels.

The company said that 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.

Nancy Simonian, chief medical officer at Millennium, said: “This first presentation of TAK-700 clinical data represents a milestone for Millennium’s prostate cancer portfolio. 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.”