Threshold Announces Positive Results From TH-070 Phase II Study

Threshold Pharmaceuticals has announced follow-up results of a Phase II study of its investigational drug candidate, TH-070 (lonidamine) for the treatment of benign prostatic hyperplasia (BPH).

Six months after cessation of treatment, BPH symptoms in patients remained significantly improved compared to baseline as were maximum urine flow, post void urine volume, and PSA. The trial, conducted in 2004 at the University of Bari, Italy, met its primary endpoint, a mean reduction in prostate volume at Day 28 compared to baseline, and all other Day 28 endpoints.

Based on promising data from the initial dose group of patients in this study, Threshold elected not to enroll a second higher dose group and instead plans to initiate a Phase II multicenter study in the U.S. and a Phase III multicenter study in Europe for TH-070 to treat symptomatic BPH in mid-2005.