BASKING RIDGE, N.J., Aug. 31 /PRNewswire/ -- Regado Biosciences, a privately held company leading the development of antithrombotic aptamers with active control agents, announced today that the results of a Phase 2a clinical trial of their lead product, the anticoagulant system REG1, were released at the European Society of Cardiology Congress in Barcelona, Spain. The results, detailed in a poster entitled, “First Clinical Application of an Actively Reversible Direct Acting Factor IXa inhibitor in Elective Percutaneous Intervention”, were presented by Dr. Mauricio Cohen, lead investigator of the study from the University of Miami-Miller School of Medicine. The poster was presented on Sunday, August 30, 2009.
The study demonstrated that the REG1 System enabled safe and effective PCI. All procedures were successfully completed in the REG1 cohorts with no signs of catheter or guidewire thrombosis. Coagulation parameters demonstrated effective, predictable and consistent ranges of anticoagulation during the study. Reversal of the anticoagulant effects of RB006 using RB007 was rapid, predictable and reproducible and permitted planned early arterial catheter sheath removal. The study also demonstrated that REG1 was well tolerated during PCI.
“This first clinical application of the REG1 System in PCI is a significant milestone in the development of this innovative and unique product. Based on these positive results, we can confidently advance to the next stage of development with the initiation of the ‘RADAR’ trial, our phase 2b study”, stated Chris Rusconi, PhD, Chief Scientific Officer and Co-Founder of Regado Biosciences. President and CEO David J. Mazzo, PhD added, “We are delighted and honored to have the REVERSAL-PCI data accepted and presented at such a prestigious meeting as the European Society of Cardiology Congress”.
ABOUT THE REG1 SYSTEM: Regado’s lead program, the anticoagulant system REG1, consists of two parenteral agents, the first being a potent and highly selective Factor IXa inhibitor (RB006) and the second being its complementary active control agent (RB007). RB007 can be used to selectively completely or partially reverse the anticoagulant effect of RB006.
More information can be found at http://www.regadobio.com
SOURCE Regado Biosciences, Inc.
CONTACT: Ellen McDonald, Chief Business Officer for Regado Biosciences,
Inc., +1-908-580-2113, emcdonald@regadobio.com
Web site: http://www.regadobio.com/
