Regado Biosciences Presents Early Stage Clinical Data for REG1 Anticoagulation System at American Heart Association 2007 Scientifi...( In Phase I Clinical Evaluation Antic...),Health

In Phase I Clinical Evaluation Anticoagulant Inhibits Clotting Factor IXa;

Matched Antidote Rapidly Reverses Anticoagulant Effect

ORLANDO, Fla., Nov. 6 /PRNewswire/ -- Regado Biosciences today presented encouraging data from Phase Ia and Phase Ib dose escalation studies of the Company's REG1 Anticoagulation System. REG1 is a two-component system consisting of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The data showed RB006 completely inhibited the activity of Factor IXa, a protein essential to blood clotting, and RB006's activity was rapidly and safely reversed by RB007 in the Phase I studies. Confirming previously reported Phase I results, these data were presented at the American Heart Association's 2007 Scientific Sessions, currently being held in Orlando, Florida.

"These Phase I results are encouraging, and this system should be evaluated further in confirmatory Phase II and III clinical studies. Experienced clinicians recognize the importance of being able to titrate the intensity of anticoagulation according to specific patient needs. Current drugs do not offer an optimal level of control or flexibility," said Richard C. Becker, M.D., Professor of Medicine, Duke University Medical Center, and Director, Duke Cardiovascular Thrombosis Center, Duke Clinical Research Institute. "Should additional well-controlled clinical studies confirm these data, REG1 may have potential for broad applications in clinical practice settings from the emergency room to the operating room."

Scientists from the Duke Clinical Research Institute and Regado analyzed REG1 pharmacokinetics and dosing data from 134 subjects enrolled in two of the three Phase I studies. The Phase Ia study enrolled 84 healthy volunteers; the Phase Ib study enrolled 50 patients with stable coronary artery disease who were receiving aspirin with or without clopidogrel. The results of the analysis showed an int
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