Comprehensive Data Provide Initial Proof of Concept Across Multiple
Applications in the Hospital Setting
Poster Presentation Number: 2032
Presenting Author: Dr. Mark Chan
MUNICH, Germany, Sept. 2 /PRNewswire/ -- Regado Biosciences, Inc. announced today the presentation of comprehensive results from Phase Ia, Ib and Ic studies of the Company's REG1 Anticoagulation System at the European Society of Cardiology's Congress 2008, currently being held in Munich, Germany. REG1 is a two-component system composed of an aptamer-based anticoagulant, RB006, and its matched, active reversal agent, RB007, which binds to and neutralizes RB006.
Results from the three Phase I studies showed RB006 inhibited the
activity of factor IXa, a protein essential to blood clotting, and RB007
rapidly, safely and specifically reversed the activity of RB006. Results
from the Phase Ic study further support the potential for RB007 to reverse
the anticoagulant effect of RB006 in a graded fashion either completely or
partially, depending on the dose of RB007. Detailed findings included:
-- Escalating doses of RB006 achieved a dose-dependent increase in
pharmacodynamic activity in healthy subjects, prolonging the activated
partial thromboplastin time (aPTT), a measure of the blood's ability to
-- This response also was seen in patients with stable coronary artery
disease, thereby confirming pharmacodynamic reproducibility in the
target patient population.
-- Escalating doses of RB007 rapidly achieved a dose-dependent decrease in
aPTT in patients previously dosed with RB006. Complete inhibition of
RB006 was shown within 1-5 minutes of administration of sufficient
doses of RB007.
-- No major bleeding, allergic or thrombotic events occurred in any of the
studies. The majority of event
|SOURCE Regado Biosciences, Inc.|
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