Regado Biosciences' REG1 anticoagulant shows positive Phase 2b results Regado Biosciences announced additional findings from its completed Phase 2b RADAR trial demonstrating the safety of early sheath removal in patients treated with REG1. The analysis showed that REG1 allowed for very early arterial sheath removal following cardiac catheterization without increasing the time to hemostasis or the frequency of vascular access-site bleeding complications. The study further determined that patients anticoagulated with REG1 during cardiac catheterization had their arterial sheath removed an average of more than three hours earlier than those anticoagulated with unfractionated heparin. Regado is currently testing REG1 in a global Phase 3 clinical trial, REGULATE-PCI, which is designed to show superiority in efficacy and non-inferiority in safety against the current standard, bivalirudin. The first of three key interim analyses in the trial is expected to occur during Q2.
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Regado terminates enrollment in REGULATE-PCI Phase 3 trial Regado Biosciences announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program, Revolixys Kit. The decision was made based on a recommendation from the trial’s Data and Safety Monitoring Board following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin. The company said, “The DSMB indicated that the level of serious allergic adverse events associated with Revolixys was of a frequency and severity such that they recommended that we do not enroll any further patients in the REGULATE-PCI trial. We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete."