SOURCE: Threshold Pharmaceuticals

Threshold Pharmaceuticals

November 03, 2014 07:05 ET

Threshold Pharmaceuticals Announces New Phase 1/2 Data on TH-302 in Glioblastoma to be Presented at the 2014 SNO Annual Meeting

SOUTH SAN FRANCISCO, CA--(Marketwired - Nov 3, 2014) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that new data from an investigator-sponsored Phase 1/2 trial evaluating the combination of TH-302 and Avastin® (bevacizumab) in patients with bevacizumab-refractory recurrent glioblastoma will be presented in two posters at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) held in Miami, Florida, from November 13-16, 2014.

Dates and times for each poster presentation are provided below.

The poster titled, "Phase 1/2 study of TH-302, investigational hypoxia-activated prodrug, and bevacizumab in patients with bevacizumab-refractory recurrent glioblastoma" (Abstract #AT-12) is being presented from 7:30 PM - 9:30 PM Eastern Time on Friday, November 14, 2014.

The poster titled, "Pharmacodynamic biomarker assessments in a Phase 1/2 trial of the hypoxia-activated prodrug TH-302 and bevacizumab in bevacizumab-refractory recurrent glioblastoma" (Abstract #DD-02) is being presented from 7:30 PM - 9:30 PM Eastern Time on Friday, November 14, 2014.

The abstracts are now available at http://neuro-oncology.oxfordjournals.org/.

About TH-302
TH-302, an investigational hypoxia-activated prodrug, is designed to be activated under severe 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 locally advanced unresectable or metastatic STS, and the other in combination with gemcitabine versus gemcitabine and placebo in patients with advanced 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 TH-302 Orphan Drug Designation for the treatment of STS and pancreatic cancer. TH-302 is also being investigated in earlier-stage clinical trials of other solid tumors and hematological malignancies.

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 the microenvironments of most solid tumors as well as the bone marrows of some patients with 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 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, the ability of Threshold, Merck KGaA, Darmstadt, Germany, to enroll or complete TH-302 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), Threshold's and Merck KGaA's (Darmstadt, Germany) dependence on single source suppliers, including the risk that these single source suppliers may be unable to meet clinical supply demands for TH-302 which could significantly delay the development of TH-302; risks related to Threshold's dependence on its collaborative relationship with Merck KGaA, Darmstadt, Germany, including its dependence on decisions by Merck KGaA, Darmstadt, Germany, regarding the amount and timing of resource expenditures for the development of TH-302; and Threshold's need for and the availability of resources to develop TH-302 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 November 3, 2014 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.

Contact Information

  • Contact

    Laura Hansen, Ph.D.
    Senior Director, Corporate Communications
    Threshold Pharmaceuticals
    Phone: 650-474-8206
    E-mail: lhansen@thresholdpharm.com