Regado Biosciences Presents Positive Data From REG1 Anticoagulation System Phase Ic Study at American Heart Association 2007 Scientifi...( Study Supports Dose-dependent...),Health

Study Supports Dose-dependent Activity of Antidote Component

ORLANDO, Fla., Nov. 4 /PRNewswire/ -- Regado Biosciences today presented data from a randomized, double-blind, placebo-controlled Phase Ic study of the Company's REG1 Anticoagulation System. REG1 is a two-component system comprised of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The study results support RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007. Consistent with previously reported Phase I results, these data were presented by the Duke Clinical Research Institute at the American Heart Association's 2007 Scientific Sessions, currently being held in Orlando, Florida.

Clinical researchers from the Duke Clinical Research Institute and Regado randomized 39 healthy volunteers to receive either three consecutive REG1 treatment cycles or placebo. Each REG1 cycle consisted of an intravenous (IV) bolus of RB006 dosed at 0.75 mg/kg, followed an hour later by a descending dose of RB007, ranging from a 2:1 to 0.125:1 antidote:drug ratio (1.5 mg/kg to 0.094 mg/kg of RB007). Clinical and coagulation assessments were measured for 14 days.

The study showed repeated doses of RB006 achieved highly reproducible increases in activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. Subsequently, repeat doses of RB007 reversed the aPTT levels dose-dependently and reproducibly. There were no major bleeding episodes or other serious adverse events reported in this study.

"I am encouraged by RB007's activity to date in reversing or neutralizing the anticoagulant effect of RB006, either completely or partially, as needed. The potential to modulate coagulation quickly based on the patient's condition represents an advance in anticoagulation therapy that could advance clinical care," said Ro
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