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Threshold Pharmaceuticals Announces Initiation of Phase 3 Trial in Europe for the Treatment of Benign Prostatic Hyperplasia

Posted on: Monday, 8 August 2005, 09:00 CDT

REDWOOD CITY, Calif., Aug. 8 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals Inc. 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<0.001), and all other day 28 endpoints. Six months after cessation of treatment, BPH symptoms (International Prostate Symptom Scores) in patients remained significantly improved compared to baseline as were maximum urine flow, post-void urine volume, and PSA (Prostate Specific Antigen).

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://www.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.

About Threshold Pharmaceuticals

Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics. By selectively targeting tumor and certain other diseased cells, the company is building a pipeline of drug candidates that hold promise to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide. For additional information, please visit http://www.thresholdpharm.com/ .

Except for statements of historical fact, the statements in this press release are forward-looking statements. Such forward-looking statements include statements regarding Threshold's clinical trial plans and potential therapeutic benefits of TH-070. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to initiate, enroll and complete its anticipated clinical trials, the time and expense required to conduct such clinical trials, and the results of such clinical trials (including unanticipated product safety issues). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on May 13, 2005 and is available from the SEC's website (http://www.sec.gov/) and on our website (http://www.thresholdpharm.com/) under the heading "Investors". We undertake no duty to update any forward-looking statement made in this news release.

Threshold Pharmaceuticals Inc.

CONTACT: Investor Contact Information: Denise T. Powell of ThresholdPharmaceuticals, +1-650-474-8206, dpowell@thresholdpharm.com; Media ContactInformation: Chris Norris of Access Communications for ThresholdPharmaceuticals Inc., +1-415-844-6285, cnorris@accesspr.com

Web site: http://www.thresholdpharm.com/http://www.medreviews.com/

Source: PRNewswire-FirstCall

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