SOUTH SAN FRANCISCO, CA--(Marketwired - October 07, 2013) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that new data on its investigational hypoxia-targeted drug, TH-302, will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 19 - 23, 2013, in Boston, MA. The presentations will characterize early data from two ongoing clinical trials evaluating combinations of TH-302 with anti-angiogenic agents in solid tumors as well as preclinical data on the tolerability and activity of TH-302, gemcitabine, and nab-paclitaxel combinations in models of pancreatic cancer.
New data from a Phase 1 clinical trial combining TH-302 and pazopanib (Investigator Sponsored Trial 4001) in patients with advanced solid tumors will be presented in a poster session on Tuesday, October 22 (Abstract #C61). Updated data from a Phase 1/2 clinical trial combining TH-302 and sunitinib (Study 410) in patients with renal cell carcinoma, gastrointestinal tumors, or pancreatic neuroendocrine tumors will be presented in a poster session on Monday, October 21 (Abstract #B77). Emerging preclinical research suggests that anti-angiogenic therapy may increase tumor hypoxia. These two clinical trials further characterize the potential of combining TH-302 with anti-angiogenic agents.
In addition, results from preclinical research evaluating combinations of TH-302, gemcitabine, and nab-paclitaxel in xenograft models of pancreatic cancer will be presented in a poster session on Tuesday, October 22 (Abstract #C287).
Abstracts are now available on the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Online Proceedings and Itinerary Planner Web page, which can be accessed at http://www.abstractsonline.com/plan/start.aspx?mkey=%7B18FA2242%2DFD0D%2D4689%2D82A0%2DE4D68AC8A74A%7D.
TH-302 is an investigational hypoxia-targeted drug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood supply as a result of aberrant vasculature. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.
TH-302 is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with advanced pancreatic cancer (MAESTRO). Both Phase 3 trials are being conducted under Special Protocol Agreements with the U.S. Food and Drug Administration (FDA). The FDA and the European Commission have granted TH-302 Orphan Drug Designation for the treatment of STS. TH-302 is also being investigated in hematological malignancies and in combination with other therapies in a variety of solid tumors.
Threshold has a global license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.S.
About Threshold Pharmaceuticals
Threshold Pharmaceuticals, Inc. 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 its 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 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 Securities and Exchange Commission on August 1, 2013 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.