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Regado Biosciences Announces Publication in Circulation of Clinical Trial Results of REG1 Anticoagulation System
Date:6/5/2008

thy volunteers to the CAD patient population," stated Doug Gooding, Chief Executive Officer of Regado Biosciences. "Following the completion of a Phase 1 program in a total of 173 patients, the Company now is evaluating this first-in-class antidote-reversible therapeutic system in a Phase 2a trial in patients undergoing elective percutaneous coronary intervention. If the results of this study further confirm the Phase 1 data, we are confident this system may be able to transform the way anticoagulation is approached in coronary revascularization procedures and other acute care settings."

Data from Regado's Phase 1b study were presented previously at the American Heart Association's 2007 Scientific Sessions.

About REG1 Anticoagulation System Clinical Program

Regado's Phase 1 program included three studies. A Phase 1a study enrolled 84 healthy volunteers, while the Phase 1b study reported above enrolled 50 patients with stable coronary artery disease who were receiving aspirin with or without clopidogrel. In addition, the Company conducted a Phase 1c clinical study, in which 39 healthy volunteers were randomized to receive either three consecutive REG1 treatment cycles or placebo. The Phase 1c study further demonstrated RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007.

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 angioplasty dilatation and stenting in patients at low risk for complications associated with therapy-related bleeding or heart attack.

About REG1 Anticoagulation System


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