Threshold completes enrollment in phase 3 study of TH-070 for benign prostatic hyperplasia

By Lisa Kerner

Erie, Pa., April 5 - Threshold Pharmaceuticals, Inc. said it has completed enrollment in the phase 3 clinical trial investigating the safety and efficacy of TH-070 in patients with benign prostatic hyperplasia (BPH), a common urological problem among older men that restricts the flow of urine, causing urinary tract infection, kidney or bladder damage and incontinence.

The phase 3 trial, conducted in Europe and Canada, is a randomized, placebo-controlled, double-blinded study of 500 men with symptomatic BPH. The primary objective of the four-and-a-half month study is to evaluate the efficacy of TH-070 compared to a placebo as measured by IPSS (International Prostate Symptom Score), according to a company news release.

"Now that enrollment has been completed in both the phase 2 and phase 3 TH-070 trials, we plan to have top line results from these trials around the beginning of the fourth quarter of this year," chief medical officer Alan Colowick said in the release.

Threshold recently completed enrollment of 200 men with symptomatic BPH in its phase 2 U.S. clinical trial. 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.

A similar phase 2 single center trial conducted in 2004 in Italy met its primary endpoint of a mean reduction in prostate volume measured by Trans-Rectal Ultrasound (TRUS) at day 28 compared to baseline, Threshold said. Six months after treatment ended, BPH symptoms, as measured by IPSS, remained improved compared to baseline.

TH-070 is believed to interfere with glycolysis on which glandular prostate epithelial cells rely. Preclinical data suggests that TH-070 may provide rapid symptom improvement, decreased prostate size, increased urine flow rate, decreased post-void residual urine volume in the bladder, and decreased serum prostate serum antigen, with limited side effects.

Threshold is a biotechnology company based in Redwood City, Calif.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.