Threshold Pharmaceuticals has completed enrollment in the Phase II study evaluating TH-070 for the potential treatment of benign prostatic hyperplasia (BPH). The study, being conducted in the U.S., is investigating the dose response of TH-070 in patients with BPH.
The trial is a randomized, placebo-controlled, double-blinded study in men with symptomatic BPH. Patients participate in the study for up to four and a half months. After a two-week placebo run-in period, patients will be randomized to receive placebo or one of four doses of TH-070 (5 mg, 25 mg, 50 mg, 150 mg) daily for 28 days, and will be followed off of therapy for an additional three months. The primary objective of this study is to investigate the dose-response relationship of TH-070 with respect to symptomatic improvement and to evaluate safety.