REDWOOD CITY, Calif., Sept. 28 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD - News), today announced that under the U.S. Orphan Drug Act, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Threshold’s product candidate, glufosfamide, for the treatment of pancreatic cancer.
Orphan Drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States. Orphan Drug designation also provides eligibility for a special seven-year period of market exclusivity upon approval, potential tax credits for research, grant funding for research and development, reduced filing fees for marketing applications, and assistance with the review of clinical trial protocols.
“We are pleased to have received this orphan drug designation for glufosfamide,” said Barry Selick, chief executive officer at Threshold. “This designation underscores the need for additional treatment options for this devastating disease.”
Last month the Company announced that it had 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. The Company expects to have top-line results from both of these clinical trials by the end of 2006.
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/m2) 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.
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/m2) weekly for 3 of every 4 weeks plus glufosfamide (4500mg/m2) 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.
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 glufosfamide product candidate, clinical trial progress and results, and potential therapeutic uses and benefits of glufosfamide. 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, the results of such clinical trials (including product safety issues and efficacy results) and our ability to source timely, satisfactory and sufficient supplies of glufosfamide. 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 August 10, 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
Source: Threshold Pharmaceuticals, Inc.
