SOUTH SAN FRANCISCO, CA--(Marketwired - November 07, 2013) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that clinical data on its investigational hypoxia-targeted drug, TH-302, will be presented at the 55th Annual Meeting of the American Society of Hematology (ASH), December 7 - 10, 2013, in New Orleans, LA. The presentations will report early data from two ongoing clinical trials, one evaluating TH-302 as single-agent monotherapy in patients with advanced leukemias (Abstract #3920), and another evaluating TH-302 with low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (Abstract #1948).
Abstract #1948: Phase 1 Study of TH-302, an Investigational Hypoxia-Targeted Drug, and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; 5:30 PM - 7:30 PM Central Time on Saturday, December 7, 2013, in Hall G.
Abstract #3920: A Phase 1 Study of TH-302, an Investigational Hypoxia-Targeted Drug, In Patients With Advanced Leukemias; 6:00 PM - 8:00 PM Central Time on Monday, December 9, 2013, in Hall E.
Abstracts are now available on the ASH website at www.hematology.org.
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, 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 soft tissue sarcoma and pancreatic cancer. 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 use of TH-302 to treat patients with advanced leukemias or multiple myeloma, other clinical trials of TH-302 and the therapeutic uses and benefits of TH-302. 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 November 4, 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.