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December 30, 2013
07:02 EDTTHLD, MKGAYThreshold Pharma says enrollment in TH-302 trial triggers milestone payment
Threshold Pharmaceuticals (THLD) announced that the target enrollment of 620 patients with advanced soft tissue sarcoma has been achieved in the company's pivotal Phase 3 trial of TH-302, its investigational hypoxia-targeted drug. The enrollment achievement triggers a milestone payment of $12.5M from Merck KGaA (MKGAY). Threshold has a global license and co-development agreement with Merck for TH-302, which includes an option for Threshold to co-commercialize in the U.S. Though Threshold will remain blinded to the data from its ongoing Phase 3 trial, an Independent Data Monitoring Committee, which monitors patient safety on an ongoing basis, will conduct an interim efficacy and safety analysis after 235 deaths are reported. The timing of the interim analysis, which is event-based and therefore dependent on the length of survival of patients, is currently projected to be conducted in mid-2014. The interim efficacy analysis is designed to allow for the early termination of the study based on achieving a pre-specified improvement in overall survival and the recommendation of the IDMC. If the IDMC recommends that the study continue as planned, Threshold will remain blinded to the data until the company conducts the primary analysis of overall survival after 434 deaths are reported. Unless the IDMC recommends that the study end early, top-line results of the primary efficacy analysis are currently projected to be reported in the first half of 2015.
News For THLD;MKGAY From The Last 14 Days
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April 7, 2014
06:15 EDTTHLDThreshold Pharmaceuticals files $150M mixed securities shelf
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06:13 EDTMKGAYOncothyreon announces Merck KGaA initiation of Phase 3 START2 study
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April 3, 2014
07:05 EDTTHLDThreshold to present results of 2 preclinical studies for combinations of TH-302
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