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

DURHAM, N.C., Nov. 1 /PRNewswire/ -- Regado Biosciences today announced the enrollment of the first patient in a multi-center, open-label, randomized Phase IIa clinical study, named REVERSAL-PCI, of its REG1 Anticoagulation System. The patient was enrolled at Black Hills Cardiology in Rapid City, SD. The study will enroll 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 on patients at low-risk for complications associated with therapy-related bleeding or heart attack. The REG1 Anticoagulation System is a combination of RB006, an intravenous anticoagulant, and its highly specific, rapidly acting antidote, RB007.

All patients will be pretreated with clopidogrel and aspirin to inhibit platelet activity. Primary procedural success will be defined by absence of significant bleeding events up to hospital discharge or 48 hours post stenting, and by absence of death, nonfatal heart attack, or need to repeat revascularization up to day 14. The study will be conducted at sites in the United States and Argentina.

"There is a significant and immediate need for an anticoagulant therapy that can be adjusted quickly and easily based on the changing medical condition of the patient. Our Phase I studies in healthy volunteers and in patients with stable coronary artery disease showed REG1 provided a safe, potent, and quickly reversible anticoagulant effect," stated Douglas Gooding, Chief Executive Officer of Regado Biosciences. "Our plan is to build on our existing data set and initiate several additional Phase II studies to establish proof of concept in a wide range of coronary revascularization procedures."

Regado has conducted three Phase I clinical studies of REG1, all of which demonstrated the anticoagulation system is safe and the antidote effective in both healthy volunteers and in older pati
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