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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)
Date:11/15/2010

BASKING RIDGE, N.J., Nov. 15, 2010 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced today two abstract presentations evaluating the potency and duration of a subcutaneous depot formulation of pegnivacogin (a.k.a. RB006), a nuclease-stabilized aptamer and direct Factor IXa inhibitor.  The studies were presented at the American Heart Association (AHA) Scientific Sessions meeting, on November 15, 2010.  

At 9:15 a.m. CST, Christopher Rusconi, Ph.D., Senior Vice President and Chief Scientific Officer, presented an abstract titled "Subcutaneous Administration of the Direct FIXa Inhibitor RB006 Provides Persistent Inhibition of Thrombin Generation."  The study examined the effects of RB006 in 28 healthy volunteers who received a single dose of 0.5, 1.0 or 3mg/kg RB006 or placebo administered subcutaneously. Results demonstrated potent, dose dependent inhibition of thrombin generation, which persisted through seven days, supporting dosing of no more than once a week.

At 11:00 a.m. CST, Steven L. Zelenkofske, D.O, F.A.C.C., Senior Vice President and Chief Medical Officer, presented an abstract titled "RB006 a Direct FIXa Inhibitor Provides Potent Concentration Dependent Suppression of Thrombin Generation."  This study was intended to better define potential dosing ranges of RB006 for future venous thromboembolism (VTE) studies.  Results revealed that while very low plasma concentrations of RB006 were needed to substantially affect the kinetics and extent of thrombin generation, very high levels of thrombin suppression could be achieved at higher plasma concentrations

The data from both abstracts are promising for future development of Regado's REG2 anticoagulant system, which consists of a subcutaneously administered depot formulation of RB006 paired with its matched active control agent, an IV bolus formulation of anivamersen (a.k.a. RB007).

Both abstracts were coauthored by Steven L. Zelenkofske, D.O., Christopher P. Rusconi, Ph.D., Carolyn M. Darmiento, MS, all from Regado Biosciences; and Richard C. Becker, MD, Duke University School of Medicine, Durham, NC; Thomas L. Ortel, M.D., Ph.D., Director, Duke Clinical Coagulation and Platelet Immunology Laboratories; and William Wargin, Ph.D. President of PK-PM Associates, LLC.

ABOUT REGADO BIOSCIENCESRegado 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, presently in a phase 2b clinical trial (the RADAR trial), is intended for application in arterial thrombosis applications, initially in Acute Coronary Syndrome patients intended for 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.

ABOUT APTAMERSPegnivacogin 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 active control agent of pegnivacogin.  

More information can be found at www.regadobio.comContact:Ellen McDonald, Chief Business Officer, Regado Biosciences, 1-908-580-2113, emcdonald@regadobio.comMedia Contact:Tiberend Strategic Advisors, Inc.1-212-827-0020Andrew Mielach, amielach@tiberendstrategicadvisors.com
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SOURCE Regado Biosciences, Inc.
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