BASKING RIDGE, N.J., April 3, 2011 /PRNewswire/ — Regado
Biosciences, Inc., a privately held company pioneering the
development of antithrombotic aptamers with active control agents,
announced today the primary results of the RADAR Phase 2b clinical
trial of the company’s lead product, the anticoagulation system
REG1, at the i2 Summit during the American College of Cardiology
2011 60th Annual Scientific Session & Expo in New Orleans, LA.
REG1 is a two-component system consisting of pegnivacogin, a
highly selective Factor IXa (FIXa) inhibitor and anivamersen, its
complementary specific active control agent.
The presentation, “A Randomized,
Partially-Blinded, Multi-Center, Active-Controlled,
Dose-ranging Study Assessing the
Safety, Efficacy and Pharmacodynamics of the REG1
Anticoagulation System Compared to Unfractionated Heparin or Low
Molecular Weight Heparin in Subjects with Acute Coronary Syndromes:
Primary Results of the RADAR Randomized Clinical Trial,” was
made by Thomas J. Povsic, MD, PhD, Assistant Professor of Medicine
at Duke University during an i2 Special Session titled
“Interventional Featured Clinical Studies I.”
The international Phase 2b RADAR clinical trial was conducted in
subjects admitted for ACS-unstable angina and myocardial infarction
without ST-segment elevation (UA/NSTEMI) intended for cardiac
catheterization within 24 hours. The objectives of RADAR were
to verify that 1 mg/kg of pegnivacogin resulted in near complete
FIXa inhibition, to determine the dose of anivamersen which, when
followed by immediate arterial sheath removal, results in a
bleeding rate lower than heparin and to assess the efficacy of REG1
(based on ischemic event rates) as an anticoagulant system in an
invasively managed ACS population. The primary endpoint of
the study was ACUITY bleeding (major and minor) at 30 days. A
secondary endpoint was
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