Threshold
Pharmaceuticals, Inc. THLD 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.
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