Regado Biosciences Completes Patient Enrollment For Phase IIa Study Of REG1 Anticoagulation System

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 Oct 2008 - 1:00 PDT

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Regado Biosciences, Inc., announced the Company has completed enrollment in the Phase IIa clinical study of its REG1 Anticoagulation System in patients undergoing elective percutaneous coronary intervention (PCI). REG1 is a two-component system composed of an aptamer-based anticoagulant, RB006, and its matched, active reversal agent, RB007, which specifically binds to and neutralizes RB006. The Phase IIa study (REVERSAL-PCI) is designed to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting on patients at low risk for complications associated with therapy-related bleeding or heart attack.

REVERSAL-PCI, a multi-center, open-label, randomized clinical study, has enrolled a total of 26 patients. All patients were pretreated with clopidogrel and aspirin to inhibit platelet activity and were then randomized to receive either REG1 or unfractionated heparin. In patients treated with the REG1 System, RB006 was used as the sole anticoagulant during the procedure. Following the procedure, RB007 was used to reverse the effects of RB006 with the goal of facilitating early sheath removal. Primary procedural success in the trial is defined by the absence of significant bleeding events up to hospital discharge or 48 hours post stenting, and by the absence of death, nonfatal heart attack, or need to repeat revascularization up to day 14.

David J. Mazzo, Ph.D., President and Chief Executive Officer of Regado Biosciences, stated, "The Phase IIa trial is designed to build on extensive Phase I results demonstrating, among other things, that RB006 safely and effectively inhibited the activity of factor IXa, an essential blood clotting protein, and that RB007 rapidly, safely and specifically reversed the activity of RB006. We are pleased to have reached this milestone in our clinical program and look forward to continued progress in the coming months."

About REG1 Anticoagulation System

The REG1 system consists of the first specific, direct-acting anticoagulant controllable by a matched reversal agent. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), put patients at a high risk for therapy-related bleeding complications. REG1 is being developed initially to increase safety and therapeutic flexibility as well as to improve patient outcomes in coronary revascularization procedures.

REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched reversal agent. The anticoagulant component, RB006, is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits factor IXa, a protein that is critical to blood coagulation. The reversal agent, RB007, is a complementary nucleic acid that specifically binds to and neutralizes RB006. The amount of RB007 administered allows physicians to rapidly fine tune the pharmacodynamic effect of RB006, from slight reduction in anticoagulation all the way to complete reversal.

About Regado Biosciences

Regado Biosciences is pioneering a new therapeutic field with the discovery and development of two-component drug systems, comprising an aptamer therapeutic that can be controlled directly by a specific and matched reversal agent. Regado's technology is designed to give physicians the ability to directly control and fine tune each product's therapeutic effect. This control and flexibility allows physicians to meet the individual needs of each patient independent of the setting. Regado initially is focusing its discovery and development efforts on acute care injectable antithrombotics, a multi-billion dollar market in need of therapeutics with improved safety profiles.

Current investors in Regado include Domain (Princeton, NJ), Quaker BioVentures (Philadelphia, PA), Aurora Funds (Durham, NC) and Caxton Advantage Life Sciences Fund (New York, NY), as well as individual investors, including Robert Kierlin.

Regado Biosciences, Inc.
http://www.regadobiosciences.com