Threshold Pharma Says Phase 3 Trial of TH-302 in Patients with Advanced Soft Tissue Sarcoma Will Continue as Planned

Threshold Pharmaceuticals, Inc.

today announced that the Independent Data Monitoring Committee (IDMC) has completed the planned interim efficacy and safety analyses of unblinded data for the Company's pivotal Phase 3 clinical trial of TH-302 in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS). Based on their analyses, which included an assessment of both benefit and risk, the IDMC recommended that the trial should continue as planned to its natural conclusion. "The IDMC's recommendation to continue the trial is in line with our expectations and previous guidance that this was the likely outcome in light of the very high statistical hurdle for demonstrating efficacy in the interim analyses," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "We look forward to the continuation of this important study with the goal of improving survival for patients with advanced STS." Threshold and its partner Merck KGaA, Darmstadt, Germany, have been and will remain blinded to the data from the trial. Based on projections derived from the interim analysis, Threshold is revising its guidance on timing for the number of events (deaths) required for the primary efficacy analysis. Previously, the Company projected the pre-specified number of events (n=434) would occur around the middle of 2015; the revised projections suggest the requisite events will occur in the latter half of 2015.