REDWOOD CITY, Calif., Aug. 8 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. , today announced that the Company has completed enrollment in a pivotal phase 3 clinical trial evaluating glufosfamide for the potential second-line treatment of pancreatic cancer and a phase 2 clinical trial evaluating glufosfamide in combination with gemcitabine for the potential first-line treatment of pancreatic cancer.
“With enrollment complete, we plan to have top-line results from these clinical trials by the end of this year,” said Alan Colowick, M.D., chief medical officer at Threshold. “If successful with the phase 3 trial, we will be that much closer to bringing another treatment option to patients with refractory pancreatic cancer.”
Phase 3 Trial Details
The phase 3 trial will evaluate approximately 300 previously-treated patients with locally advanced and/or metastatic pancreatic cancer who receive best supportive care (BSC) or glufosfamide (4500mg/m^2) once every 3 weeks plus BSC. Best supportive care includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells. The primary endpoint of this trial is overall survival as measured by time from randomization to death. The timing of the final analysis is therefore event-driven and will be conducted after the 258th death has occurred. In addition, the trial will investigate the potential efficacy of glufosfamide as determined by response rate, duration of response and progression-free survival, as well as safety.
The phase 3 trial is being conducted under a Special Protocol Assessment (SPA). The SPA agreement with the FDA indicates that if the trial successfully meets its primary efficacy endpoint and satisfies other criteria, the data will provide support for an efficacy claim in a marketing application to the FDA. In 2004, the FDA granted fast track status to this program which provides for expedited regulatory review for new drugs that demonstrate the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. According to the FDA, glufosfamide was designated as a fast track product candidate both because of the severity of pancreatic cancer and because glufosfamide may provide a therapeutic benefit to the intended patient population.
Phase 2 Trial Details
The phase 2 trial will evaluate up to 28 previously-untreated patients with locally advanced and/or metastatic pancreatic cancer who receive the standard dose of gemcitabine (1000mg/m^2) weekly for 3 of every 4 weeks plus glufosfamide (4500mg/m^2) administered once every 4 weeks. In addition to safety, the trial will investigate the efficacy of glufosfamide in combination with gemcitabine as determined by response rate, duration of response, progression-free survival, overall survival, six- and twelve-month survival and change in serum tumor marker levels.
Glufosfamide Phase 1 and 2 Data in Pancreatic Cancer
Previous trials have demonstrated that glufosfamide kills cancer cells and can shrink pancreatic cancers. Data from an initial phase 1 trial of glufosfamide were published in the Journal of Clinical Oncology (October 2000). This trial determined the maximum tolerated dose of glufosfamide in patients with a variety of solid tumors. The only pancreatic cancer patient enrolled in this phase 1 trial achieved a complete response and remained in remission at least five years later after receiving glufosfamide treatment alone.
Data from a phase 2 trial of glufosfamide for the treatment of pancreatic cancer were reported at the 93rd Annual Meeting of the American Association for Cancer Research (AACR), April 6-10, 2002, as well as published in the November 2003 issue of the European Journal of Cancer. The fully enrolled trial included 35 chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer. This trial was enrolled from February 2000 to March 2001. The data documented objective tumor shrinkage, which was verified by an independent review of radiographs. An analysis of survival demonstrated an estimated 9% two-year survival. Careful monitoring of renal function was required. Hematological toxicity was mild, and the most common adverse effects were grade I nausea and vomiting.
About Pancreatic Cancer
The American Cancer Society estimates that 33,730 patients will be diagnosed with pancreatic cancer in the United States in 2006, and approximately 32,300 patients will die from the disease. Only 15-20% of newly diagnosed patients are eligible for surgery, which is typically followed by radiation and chemotherapy. Patients with inoperable pancreatic cancer are treated with radiation and chemotherapy, or in the case of advanced disease, chemotherapy alone as the advantages of radiation are reduced.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of small molecule therapeutics for the potential treatment of cancer. By selectively targeting abnormally-proliferating tumor 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 ( 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 commence, enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, issues arising in the regulatory process and the results of such clinical trials (including product safety issues and efficacy results). 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 15, 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 Threshold Pharmaceuticals, Inc. 650-474-8206 dpowell@thresholdpharm.com
Threshold Pharmaceuticals, Inc.
CONTACT: Denise T. Powell, Sr. Director, Corporate Communications ofThreshold Pharmaceuticals, Inc., +1-650-474-8206, ordpowell@thresholdpharm.com
Web site: http://www.thresholdpharm.com/
