REDWOOD CITY, Calif., April 5 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. , today announced that the Company has completed enrollment in its Phase 3 clinical trial evaluating TH-070 for the potential treatment of benign prostatic hyperplasia (BPH). The Phase 3 trial, being conducted in Europe and Canada, is investigating the safety and efficacy of TH-070 in patients with BPH.
“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,” said Alan Colowick, M.D., chief medical officer at Threshold. “Rapid enrollment into both of these trials reflects the enthusiasm and support of the clinical investigators and their staff who are dedicated to finding improved treatment options for their patients with BPH.”
The Phase 3 trial is a randomized, placebo-controlled, double-blinded study in men with symptomatic BPH. Approximately 500 patients are participating in the study for up to four and a half months. The primary objective of this study is to evaluate the efficacy of TH-070 compared to placebo as measured by IPSS (International Prostate Symptom Score) in subjects with symptomatic BPH.
The Company recently announced the completion of enrollment in a Phase 2 clinical trial in the United States in men with symptomatic BPH. Approximately 200 patients are participating for up to four and a half months in this trial whose primary objective is to investigate the dose-response relationship of TH-070 with respect to symptomatic improvement and to evaluate safety.
Threshold previously announced the results from a Phase 2 single center clinical trial 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 (as measured by IPSS) 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 trial were published in the quarterly journal of Reviews in Urology in May, 2005.
2006 TH-070 Key Milestones
The Company anticipates the following clinical milestones related to TH-070 in 2006:
-- report results from the Phase 2 and Phase 3 studies in BPH with TH-070 around the beginning of the fourth quarter; and -- commence three supportive studies with TH-070
About TH-070TH-070 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 primarily dependent on glycolysis for energy production. Preclinical data and Phase 2 data thus far indicate 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 PSA, with limited side effects for the treatment of BPH.
About Benign Prostatic Hyperplasia (BPH)
BPH 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 8 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 the risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence.
About Threshold Pharmaceuticals, Inc.
Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics in middle- and late- stage clinical trials for the potential treatment of benign prostatic hyperplasia (BPH), a disease afflicting tens of millions of men worldwide, and cancer. By selectively targeting tumor or other abnormally-proliferating cells, the Company’s drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. For additional information, please visit our website: http://www.thresholdpharm.com .
Forward-Looking Statements
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold’s product candidates, clinical trial progress and results, and potential therapeutic uses and benefits of our product candidates. 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 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 as well as efficacy results). Further information regarding these and other risks is included under the heading “Risk Factors” in Threshold’s Annual Report on Form 10-K, which was filed with the Securities Exchange Commission on March 28, 2006 and is available from the SEC’s website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading “Investors.” We undertake no duty to update any forward-looking statement made in this news release.
Contact: Denise T. Powell, Sr. Director, Corporate Communications of Threshold Pharmaceuticals, Inc., +1-650-474-8206, or dpowell@thresholdpharm.com; or Carolyn Bumgardner Wang of WeissComm Partners, Inc., +1-415-946-1065, or carolyn@weisscommpartners.com.
Threshold Pharmaceuticals, Inc.
CONTACT: Denise T. Powell, Sr. Director, Corporate Communications ofThreshold, +1-650-474-8206, or dpowell@thresholdpharm.com; or CarolynBumgardner Wang of WeissComm Partners, Inc., +1-415-946-1065, orcarolyn@weisscommpartners.com
Web site: http://www.thresholdpharm.com//
