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Regado Biosciences Releases Positive Phase 2a Data for the Reversible Anticoagulant System REG1 at the European Society of Cardiology Congress In Barcelona, Spain
Date:8/31/2009

BASKING RIDGE, N.J., Aug. 31 /PRNewswire/ -- Regado Biosciences, a privately held company leading the development of antithrombotic aptamers with active control agents, announced today that the results of a Phase 2a clinical trial of their lead product, the anticoagulant system REG1, were released at the European Society of Cardiology Congress in Barcelona, Spain. The results, detailed in a poster entitled, "First Clinical Application of an Actively Reversible Direct Acting Factor IXa inhibitor in Elective Percutaneous Intervention", were presented by Dr. Mauricio Cohen, lead investigator of the study from the University of Miami-Miller School of Medicine. The poster was presented on Sunday, August 30, 2009.

This was the first study to evaluate REG1 in a clinical setting involving percutaneous coronary intervention (PCI). REG1 is a two component system consisting of RB006, a direct FIXa inhibitor and RB007, the active, specific control agent for RB006. This phase 2a study (REVERSAL-PCI) was an open-label, randomized, multicenter study that evaluated feasibility and safety during elective PCI comparing the REG1 anticoagulant system with unfractionated heparin in patients with coronary artery disease. All 26 patients in the study received aspirin and clopidogrel as background therapy. The primary endpoint of the study was major bleeding within 48 hours. Important secondary endpoints were a composite of death, myocardial infarction or urgent target vessel revascularization within 14 days and pharmacodynamic measures. The three arms of the study were designed to measure both total and partial anticoagulant reversal, with all REG1 subjects undergoing planned early arterial catheter sheath removal.

The study demonstrated that the REG1 System enabled safe and effective PCI. All procedures were successfully completed in the REG1 cohorts with no signs of catheter or guidewire thrombosis. Coagula
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SOURCE Regado Biosciences, Inc.
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