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news.Threshold Pharmaceuticals has completed enrollment in the phase II study evaluating TH-070 for the potential treatment of benign prostatic hyperplasia.
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The phase II trial is a randomized, placebo controlled, double-blinded study in men with symptomatic benign prostatic hyperplasia (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 (5mg, 25mg, 50mg, 150mg) daily for 28 days, and will be followed for an additional three months after therapy.
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.
“We are pleased to have reached this milestone. We anticipate that we will have top line results around the beginning of the fourth quarter this year,” said Dr Alan Colowick, chief medical officer at Threshold. “We look forward to the continued development of TH-070 and to the potential benefit that TH-070 may provide to men suffering from the symptoms of BPH.”