The company announced in
New findings on overall survival, which was a secondary endpoint of the study, indicate that patients treated with gemcitabine alone had a median overall survival of 6.9 months compared with 9.2 months for patients treated with 340 mg/m2 TH-302 plus gemcitabine (HR: 0.955, 95% CI: 0.67-1.37, p=0.800) and 8.7 months for patients treated with 240 mg/m2 TH-302 plus gemcitabine (HR: 0.960, 95% CI: 0.67-1.38, p=0.827). While not statistically significant, the improvement in median overall survival is consistent with the improvement in median PFS reported previously. The trial was not designed to detect a statistically significant improvement in overall survival and included a cross-over component. Patients receiving gemcitabine alone who crossed over to receive gemcitabine plus TH-302 upon disease progression did contribute to an increase in survival of the control arm.
TH-302 continues to demonstrate a safety profile consistent with what has been previously reported at the 2012 annual meeting of the
"We are pleased with the overall consistency of results from this study demonstrating activity of TH-302 and, as a consequence, a randomized Phase 3 trial of TH-302 in patients with advanced first-line pancreatic cancer is planned to be initiated together with our partner Merck KGaA," said
About the Phase 2b Study
The Phase 2b study is a randomized controlled trial that enrolled a total of 214 previously untreated patients with locally advanced unresectable or metastatic pancreatic cancer. Patients were randomized to treatment with either 240 mg/m2 TH-302 plus gemcitabine (n=71), or 340 mg/m2 TH-302 plus gemcitabine (n=74), or gemcitabine alone (n=69). Patients receiving gemcitabine alone whose disease progressed were permitted to be randomized to treatment with gemcitabine plus either the low or high dose of TH-302. The trial was 80% powered to detect a 50% improvement in PFS with a p-value of 0.20.
About the ESMO 2012 Congress Abstract and Presentation
Please note that the ESMO 2012
About Pancreatic Cancer
Pancreatic cancer is a malignant neoplasm of the pancreas with current treatment options including surgery, radiotherapy and chemotherapy. Gemcitabine as a single agent or in combination with other treatments is the most commonly used chemotherapeutic agent in patients with advanced pancreatic cancer. According to the
TH-302 is a hypoxia-targeted drug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Areas of low oxygen levels (hypoxia) are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic.
TH-302 has been investigated in over 700 patients in Phase 1/2 clinical trials to date in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs. Threshold has several additional ongoing clinical trials, the most advanced of which is a Phase 3 pivotal study evaluating TH-302 in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma. In
Threshold is a biotechnology company focused on the discovery and development of drugs targeting Tumor Hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit our website (www.thresholdpharm.com).
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding the potential therapeutic uses and benefits of TH-302 to treat patients with cancer. 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 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 or manufacturing 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 has been filed with the
Laura Hansen, Ph. D. Senior Director, Corporate Communications Threshold PharmaceuticalsPhone: 650-474-8206 E-mail: email@example.com
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