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Phase 3 Efficacy Trial of Lonidamine To Begin in Europe

REDWOOD CITY, Calif., Aug. 8 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals Inc. (NASDAQ:THLD) today announced the initiation of a Phase 3 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 3 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 (50 mg, 150 mg) compared to placebo as measured by I-PSS (International Prostate Symptom Scores) in subjects with symptomatic BPH.

"We are excited about the potential of this therapy based on promising Phase 2 clinical data," said Alan Colowick, chief medical officer of Threshold. "This is another important clinical milestone in our registrational program. The Phase 3 European trial complements our Phase 2 trial recently begun in the United States."

The study is also designed to confirm the findings for 28 days of dosing previously announced by Threshold from a Phase 2 single center study conducted in 2004 at the University of Bari, Italy. That trial met its primary endpoint, a mean reduction in prostate volume measured by trans-rectal ultrasound (TRUS) at day 28 compared to baseline (-11.2%, p Detailed results of the study were published by MedReviews in the quarterly journal of Reviews in Urology. The information is available online at the MedReviews website http://medreviews.com/ .

About TH-070 and prostate metabolism
TH-070, an indazole-3-carboxylic acid, is thought to disrupt energy metabolism by interfering with glycolysis. Glandular prostate epithelial cells -- cells that overgrow in BPH -- are unique in that they are dependent on glycolysis for energy production. Preclinical data and Phase 2 data thus far support that TH-070 presents a potentially effective method for targeting these prostate cells and may provide rapid symptom improvement, decreased prostate size, increase in urine flow, decreased serum PSA, and limited side effects for the treatment of BPH.

About Benign Prostatic Hyperplasia (BPH)
BPH, also known as benign enlargement of the prostate, is the most common urological problem among older men and affects an estimated 18 million men in the United States, 28 million men in five major European countries and eight million men in Japan. BPH can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. It can also be progressively severe, with a risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. However, current drug and surgical therapies for BPH are not completely effective, often having slow onset and with side effects ranging from decreased libido, sexual dysfunction and reduced quality of life to cardiovascular effects and/or surgical complications.

Source: Threshold Pharmaceuticals Inc.

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