Threshold Pharma (THLD) Reports Data on Evofosfamide in Relapsed/Refractory Multiple Myeloma to Be Presented at ASCO
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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.
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.
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