Results from Regado's 1c study were presented previously at the American Heart Association's 2007 Scientific Sessions.
About REG1 Anticoagulation System Clinical Program
In the Phase 1c clinical study, the researchers 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 Phase 1 program included two additional studies. A Phase 1a study enrolled 84 healthy volunteers, while a Phase 1b study enrolled 50 patients with stable coronary artery disease who were receiving aspirin with or without clopidogrel. The results showed an IV bolus injection of RB006 achieved, in both study populations, a prompt, consistent, and dose-dependent prolongation of activated partial thromboplastin time (aPTT). In addition, a 1 mg/kg dose of RB006 resulted in essentially complete Factor IXa inhibition. The studies also demonstrated an IV bolus injection of RB007 administered in a 2:1 antidote:drug ratio successfully reversed prolonged aPTT within a median of one minute, with no rebound increase up to seven days. Despite dual antiplatelet use in 19 subjects, there were no major bleeding or other serious adverse events observed in either study.
Based upon the combined results of the Company's Phase 1a, 1b, and 1c
studies, Regado initiated REVERSAL-PCI, a multi-center, open-label,
randomized Phase 2a clinical study of the REG1 anticoagulation system. The
Phase 2a study is enrolling 26 patients undergoing elective percutaneous
coronary intervention (PCI) to assess whether REG1 can replace standard
heparin therapy during the performance of coronary balloon an
|SOURCE Regado Biosciences|
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