Transition Therapeutics signs deal for phase 2 study of TT701 drug candidate

TTIL will support a Phase 2 study to evaluate selective androgen receptor modulator (SARM) drug candidate TT701 as a therapy to improve the symptoms of androgen deficiency in men with prostate cancer who have undergone a radical prostatectomy procedure.

The Phase 2 clinical study is expected to enroll up to 125 subjects and will be performed at selected specialized clinical sites including BWH. The principal investigator for the Phase 2 study will be Shalender Bhasin, Director of the Research Program in Men’s Health: Aging and Metabolism at BWH and an internationally recognized endocrinologist with expertise in testosterone biology and men’s aging.

Bhasin said: "Improved survival of men with prostate cancer has focused attention on the high prevalence and adverse effects of the distressing symptoms of androgen deficiency – sexual dysfunction, fatigue, and physical dysfunction – on the quality of life of prostate cancer survivors.

"This trial offers the opportunity to potentially improve the lives of men with a history of prostate cancer, who experience these bothersome symptoms of androgen deficiency after prostate surgery."

Transition Therapeutics chairman and CEO Tony Cruz said: "We are extremely pleased to work together with BWH and Dr. Shalender Bhasin on the development of the TT701 drug candidate.

"BWH is a world-class center for clinical research with renowned physician-investigators, biomedical scientists and faculty. Dr. Bhasin’s expertise in the field of androgen deficiency is well-known and his leadership of the TT701 Phase 2 study underscores the importance to finding therapies to aid these individuals and their challenging symptoms.

The Phase 2 study is scheduled to commence in calendar Q4 2015.