Threshold Pharmaceuticals completes enrollment in phase 2 hyperplasia study

By Elaine Rigoli

Tampa, Fla., March 20 - Threshold Pharmaceuticals, Inc. said the company has completed enrollment in the phase 2 study evaluating TH-070 for the potential treatment of benign prostatic hyperplasia (BPH).

The phase 2 trial is a randomized, placebo controlled, double-blinded study in men with symptomatic BPH.

Patients in the study, being conducted in the United States, will participate in the study for up to four-and-a-half months, according to a company news release.

After a two-week placebo run-in period, patients will be randomized to receive a 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, the release said.

Threshold is also conducting a phase 3 randomized, placebo-controlled, double-blinded study in men with symptomatic BPH. Enrollment in this trial is expected to be completed in April.

The primary objective of this study is to evaluate the efficacy of TH-070 compared to a placebo as measured by the international prostate symptom score in subjects with symptomatic BPH.

Redwood City, Calif.-based Threshold is a biotechnology company focused on the discovery, development and commercialization of mid- to late-stage small molecule therapeutics for the treatment of benign prostatic hyperplasia and cancer.

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