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Regado Biosciences Initiates Phase IIa Clinical Study of REG1 Anticoagulation System
Date:11/1/2007

ents with stable coronary artery disease.

"I am very pleased with the results of this first clinical experience with the REG1 system during a stent procedure. We anticipate this drug will fulfill multiple unmet needs in the care of heart patients," stated Mauricio Cohen, MD, the Director of Cardiology Clinical Trials at the University of North Carolina and Principal Investigator of the REVERSAL-PCI study. "The lack of a safe and at the same time efficacious reversible blood thinner has been a major problem for cardiologists performing invasive catheterization procedures. We are hopeful that this agent will revolutionize the approach to anticoagulation during catheter-based interventions and the care of heart attack patients."

Currently, heparin and protamine are the only approved therapeutic/antidote drug pair used in surgical procedures, such as PCI. However, these drugs have well-known limitations, including the risk for developing heparin-induced thrombocytopenia (with or without thrombosis), as well as protamine-associated side effects, such as anaphylaxis and systemic hypotension.

About REG1 Anticoagulation System

Regado's lead product candidate, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at a high-risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.

REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits
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SOURCE Regado Biosciences
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