SOURCE: Threshold Pharmaceuticals

Threshold Pharmaceuticals

May 13, 2015 17:05 ET

Threshold Announces Clinical Update on Evofosfamide in Relapsed/Refractory Multiple Myeloma to Be Presented at ASCO 2015

SOUTH SAN FRANCISCO, CA--(Marketwired - May 13, 2015) -  Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that new clinical data from its ongoing Phase 2 clinical trial evaluating evofosfamide (previously known as TH-302), an investigational compound, with bortezomib (Velcade®) and dexamethasone in patients with relapsed/refractory multiple myeloma will be presented on Sunday, May 31, 2015, at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place May 29 - June 2, 2015, in Chicago, Illinois (Abstract #8579). In addition, a trials-in-progress poster will be presented on the Company's Phase 2 trial of evofosfamide in patients with advanced melanoma (Abstract #TPS9089). Abstracts are now available on the ASCO website at http://abstracts.asco.org/. Presentation details are as follows:

Abstract #8579 (Poster #397): Preliminary safety and efficacy of evofosfamide (TH-302), an investigational hypoxia-activated prodrug, combined with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma (RR MM); Poster Session on Lymphoma and Plasma Cell Disorders, 8:00 AM - 11:30 AM Central Time, Sunday, May 31, 2015, S Hall A. 

Abstract #TPS9089 (Poster #327a): A Phase 2 biomarker-enriched study of evofosfamide (TH-302) in patients with advanced melanoma; Poster Session on Melanoma/Skin Cancers, 1:15 PM - 4:45 PM Central Time, Monday, June 1, 2015, S Hall A. 

About Evofosfamide

Evofosfamide (previously known as TH-302), an investigational hypoxia-activated prodrug, 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.

Evofosfamide is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug Designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Threshold has a global license and co-development agreement for evofosfamide 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 therapeutic uses and benefits of Threshold's drug 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: the ability of Threshold and its partner, Merck KGaA, Darmstadt, Germany, to enroll or complete 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); risks related to Threshold's dependence on its collaborative relationship with Merck KGaA, Darmstadt, Germany; and Threshold's need for and the availability of resources to develop its drug candidates and to support Threshold's operations. 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 April 30, 2015 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.

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