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Regado Biosciences, Inc. Presents Results of the RADAR Phase 2b Clinical Trial of its REG1 Anticoagulation System
Date:4/3/2011

a composite of death, myocardial infarction (MI), urgent target vessel revascularization (TVR) or recurrent ischemia at 30 days.  

Previously presented data from RADAR (AHA, November 2010) confirmed that pegnivacogin dosed at 1mg/kg reproducibly resulted in near complete inhibition of FIXa in an ACS population.  The latest RADAR results showed that ACUITY major bleeding following immediate sheath removal exhibited a dose response with bleeding rates decreasing with increasing levels of reversal.  Rates of bleeding were lower in the 75% and 100% reversal arms than heparin.  In addition, the incidence of ischemic events was lower in REG1 treated patients compared with those treated with heparin.  

Adverse events (AEs) other than bleeding and ischemic events were rare and evenly distributed among the arms of the study.  Three patients, clustered late in the trial and in Europe, had allergic-like reactions shortly after receiving pegnivacogin.  Characterization of these reactions is ongoing.  

"We are thrilled by the results of RADAR and the groundbreaking advance in anticoagulant therapy that they foretell.  It is now clear that control matters.  REG1 uniquely has shown the promise of simultaneously reducing ischemia and bleeding in comparison to heparin," said Dr. David J. Mazzo, President and CEO of Regado Biosciences, Inc.  He added, "The results of the RADAR trial solidly support Phase 3 development of REG1 in the broader ACS population.  Regado plans to move forward in this indication as well as in a parallel indication of open heart surgery."  

"The Phase 2b RADAR results suggest that high intensity FIXa inhibition with active control may ultimately represent a potential treatment option for addressing both ischemic and bleeding endpoints for patients who require short term anticoagulation in acute care settings," said John H. Alexander, MD, MHS, FACC of the Duke Clinica
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1. Regado Biosciences to Present at the Needham & Companys 10th Annual Healthcare Conference in New York City
2. Regado Biosciences, Inc. Announces Presentation of the Results of the RADAR Phase 2b Clinical Trial of Its Anticoagulant System REG1 at the i2 Summit During the American College of Cardiology 2011 60th Annual Scientific Session & Expo in New Orleans
3. Regado Biosciences to Present at the 2011 RBC Capital Markets Healthcare Conference in New York City
4. Regado Biosciences, Inc. Introduces REG3, a Novel Aptamer-Based Inhibitor of Glycoprotein VI and its Matched Active Control Agent, at the American Heart Association (AHA) Scientific Sessions 2010 Meeting
5. Regado Biosciences, Inc. Presents Pharmacokinetic and Pharmacodynamic (PK/PD) Substudy Results From its Phase 2b RADAR Trial at the American Heart Association (AHA) Scientific Sessions 2010 Meeting
6. Regado Biosciences, Inc. Presents Two Abstracts on the Subcutaneous Depot Formulation of Pegnivacogin, a Nuclease-Stabilized RNA Aptamer, Direct Factor IXa Inhibitor and Part of the REG2 Anticoagulant System, at the American Heart Association (AHA)
7. Regado Biosciences to Present at the IMPACT 2010 Conference in Philadelphia, Pennsylvania
8. Regado Biosciences, Inc. Presents the First-In-Human Clinical Experience with REG2 at the American College of Chest Physicians (ACCP) Coagulation and Heart Disease Sessions in Vancouver, BC, Canada on November 2, 2010
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