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, LA
BASKING RIDGE, N.J., March 28, 2011 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company pioneering the development of antithrombotic aptamers with active control agents, announced that Thomas J. Povsic, MD, PhD, Assistant Professor of Medicine at Duke University, will present results of the RADAR Phase 2b clinical trial for the Company's lead product, the REG1 anticoagulation system, at the i2 Summit during the American College of Cardiology 2011 60th Annual Scientific Session & Expo.
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," will be given during an i2 Special Session entitled: "Interventional Featured Clinical Studies I" on Sunday, April 3, 2011 at 1:15 p.m. CDT at the Ernest N. Morial Convention Center in New Orleans, LA.
REG1 comprises a two-component system; a highly selective Factor IXa inhibiting aptamer, pegnivacogin, and its complementary specific active control agent, anivamersen. Anivamersen can be used to selectively reverse (completely or partially) the anticoagulant effect of pegnivacogin in real time.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc. is a private biopharmaceutical company pioneering a new therapeutic technology with the creation and development of proprietary controllable aptamer drug systems. Each system comprises a nuclease-stabilized RNA aptamer, the therapeutic effect of which can be reversed partially or completely in real time by its specific and complementary oligonucleotide active control agent. This technology is being applied to injectable antithrombotics (including anticoagulants and antiplatelet agents) in the acute and sub-acute care cardiovascular setting, a multi-billion dollar world-wide market in need of drugs with improved safety profiles and a greater degree of therapeutic control. The products in Regado's pipeline are designed to act as optimized antithrombotics, uniquely concomitantly minimizing the risk of ischemia and bleeding, and, by allowing patient specific tuning of the desired therapeutic effect, providing a safe and unique approach to personalized medicine.
ABOUT REG1, REG2 and REG3
Regado's lead program, the anticoagulant system REG1, consists of two parenteral agents both administered by IV bolus, the first being a potent highly selective Factor IXa inhibitor (pegnivacogin, a.k.a. RB006) and the second being its complementary active control agent (anivamersen, a.k.a. RB007). Anivamersen can be used to selectively completely or partially reverse the anticoagulant effect of pegnivacogin. REG1, having recently completed phase 2b clinical development (the RADAR trial), is intended for application in arterial thrombosis indications, such as Acute Coronary Syndrome patients undergoing Percutaneous Coronary Intervention. A clinical program in Open Heart Surgery [including coronary artery bypass grafting (CABG) and valve repair/replacement] is also under development. REG2, Regado's second product candidate, consists of a subcutaneously administered depot formulation of pegnivacogin paired with the IV bolus formulation of anivamersen. REG2 recently completed single escalating dose phase 1 clinical testing (the first successful subcutaneous application of an aptamer in humans) and is planned to be studied in a multiple escalating dose clinical trial in 2011. It is intended for use in venous thrombosis indications such as venous thromboembolism (VTE) prophylaxis in patients undergoing abdominal surgery. REG3, Regado's third program, consists of a specific GPVI inhibitor and its active control agent (RB571 and RB515, respectively). REG3 is planned to enter phase 1 human clinical testing in 2011 and will be indicated for antiplatelet therapy. Information pertaining to Regado's clinical programs may be obtained at www.clinicaltrials.gov.
Pegnivacogin is a member of a class of compounds called aptamers. Aptamers are single stranded oligonucleotides that adopt a specific conformation enabling direct, specific inhibition of the targeted protein. A key unique feature of aptamers derives from the fact that they are formed from nucleic acids. As such, their pharmacologic activity can be controlled by a matched, complementary oligonucleotide active control agent (the Watson-Crick base pair complement of a fraction of the agent to be controlled), which can bind to the aptamer, removing it from its target and reversing its biologic effects. Anivamersen is the complementary active control agent of pegnivacogin.
More information can be found at www.regadobio.com
Contact: Ellen McDonald, Chief Business Officer, Regado Biosciences
SOURCE Regado Biosciences, Inc.