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Home » PHASE III TRIAL FOR PROSTATIC HYPERPLASIA BEGINS IN EUROPE
PHASE III TRIAL FOR PROSTATIC HYPERPLASIA BEGINS IN EUROPE
August 8, 2005
Threshold Pharmaceuticals has initiated a Phase III clinical trial as part of a registrational program of its investigational drug candidate TH-070 (lonidamine).
The study will measure the dosing, safety, and efficacy of TH-070 in subjects with symptomatic benign prostatic hyperplasia (BPH). The company has begun patient enrollment and will conduct the trials at nearly 60 investigational sites in selected European countries.
The Phase III trial will be a randomized, placebo-controlled, double-blinded study, enrolling men 50-80 years of age with symptomatic BPH. Approximately 480 patients will participate in the study for up to four and a half months. The primary objective is to evaluate the efficacy of TH-070 compared to placebo as measured by International Prostate Symptom Scores in subjects with symptomatic BPH.
The study is also designed to confirm the findings for 28 days of dosing previously announced by Threshold from a Phase II single center study conducted in 2004 at the University of Bari in Italy. That trial met its primary endpoint, a mean reduction in prostate volume measured by trans-rectal ultrasound at Day 28 compared to baseline, and all other Day 28 endpoints. Six months after cessation of treatment, BPH symptoms in patients remained significantly improved compared to baseline.
KEYWORDS Drug Pipeline Alert
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