site. The incidence of additional minor events, including headache,
dizziness, nausea, fatigue and hypotension, was similar to placebo.
"Our studies consistently have confirmed the two major attributes of the REG1 system, rapid anticoagulant activity and rapid and predictable reversal of this effect," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Regado Biosciences. "Based on the encouraging Phase I study data, we anticipate results from our ongoing Phase IIa studies evaluating REG1 in
patients undergoing elective PCI will further confirm that REG1 has the potential to replace standard heparin therapy."
"In striving to meet the needs of individual patients in varied and oftentimes complex settings, it is essential for physicians to quickly, safely and effectively achieve the desired anticoagulation effect and, when required for specific clinical indications, to attenuate or fully reverse this effect," stated Richard C. Becker, M.D., Professor of Medicine, Duke University Medical Center, and Director, Duke Cardiovascular Thrombosis Center, Duke Clinical Research Institute. "As we enter a new era of anticoagulant pharmacotherapy, a therapeutic system offering these attributes would be of great benefit and may have a profound impact on patient care."
Clinician-scientists from the Duke Clinical Research Institute (DCRI)
and Regado evaluated REG1 in three Phase I studies: Phase Ia, a healthy
volunteer drug dose-escalating pharmacokinetic-pharmacodynamic (PK-PD)
study; Phase Ib, a drug dose-escalating study in subjects with stable
coronary artery disease who were receiving aspirin with or without
clopidogrel; and Phase Ic, a multiple exposure, dose-ranging study in 39
healthy volunteers. Top-line results from these three studies were
presented last year at the American Heart Association's 2007 Scientific
Sessions and subsequently published in top-tier scientifi
|SOURCE Regado Biosciences, Inc.|
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