First patient enrolled in Phase 2b RADAR clinical trial

Regado Biosciences, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, announced that on September 8, 2009 enrollment of the first patient in a Phase 2b, randomized, partially-blinded, multi-center, active-controlled, dose-ranging study of its lead product candidate, the REG1 anticoagulation system (REG1) was achieved. REG1 comprises the selective factor IXa inhibitor, RB006, and its specific active control agent, RB007. The trial, called RADAR, will assess the safety, efficacy, and pharmacodynamics of REG1 compared to unfractionated heparin or low molecular weight heparin in subjects with acute coronary syndromes (ACS). Regado recently successfully completed a phase 2a study of REG1 in stable coronary artery disease patients undergoing elective PCI.

The primary objectives of RADAR will be to determine the clinically acceptable dose range of the specific active control agent, RB007, which can be used to reliably partially or totally reverse the anticoagulant effect of RB006 while reducing bleeding in comparison to heparin, and to determine the pharmacodynamics of the REG1 anticoagulation system in subjects intended for cardiac catheterization within 24 hours who are admitted for ACS-unstable angina and myocardial infarction without ST-segment elevation (UA/NSTEMI).

RADAR, led by principal investigator John H. Alexander, MD, MHS, FACC of Duke University, will enroll 800 subjects at approximately 75 centers around the world. Participating countries include USA, Canada, Poland, France, Germany, Netherlands and Belgium. More information about RADAR can be found at www.clinicaltrials.gov. The identifier for this trial is NCT00932100.

"We are very excited to report the first patient being enrolled in the RADAR study," stated Steven L. Zelenkofske, DO, FACC, Chief Medical Officer of Regado Biosciences. "This event marks a key milestone in the development of this innovative anticoagulation system with its simple yet elegant approach to balancing concomitantly risk reduction of ischemia and bleeding." David J. Mazzo, Ph.D., President and CEO of Regado Biosciences, added, "Successful development of REG1 promises to bring an unprecedented level of control to the physician, ultimately leading to improved outcomes and better safety for patients in the multi-billion dollar worldwide market of antithrombotic therapies."