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Threshold Pharmaceuticals Announces TH-302 Data To Be Presented At ASH

Published: Nov 7, 2013 9:00 am

South San Francisco, CA (Press Release) - 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 Details

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.

About TH-302

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).

Forward-Looking Statements

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.

Source: Threshold Pharma­ceu­ticals.

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