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Regado Biosciences Presents the First-In-Human Clinical Experience with REG2 at the American College of Chest Physicians Coagulation and Heart Disease Sessions


11/3/2010 6:53:48 AM

BASKING RIDGE, N.J., Nov. 2, 2010 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced that Steven L. Zelenkofske, D.O., F.A.C.C., Senior Vice President and Chief Medical Officer, presented an abstract at the American College of Chest Physicians (ACCP) Coagulation and Heart Disease Sessions on November 2, 2010 in Vancouver, BC, Canada. The abstract is titled "Sustained Inhibition of Factor IXa by Subcutaneous RB006 with Active Reversal: First-in-Human Experience with the REG2 System."

The REG2 system is intended for use in venous thrombosis indications. This initial Phase 1 study was the first successful subcutaneous application of an aptamer in humans. It demonstrated that a single subcutaneous injection of RB006 (aka pegnivacogin) resulted in dose-dependent inhibition of Factor IXa with effects that persisted longer than one week after injection. The data is promising for future development of REG2.

The abstract is coauthored by Steven L. Zelenkofske, D.O., Christopher P. Rusconi, Ph.D. and Carolyn M. Darmiento, MS, all from Regado Biosciences; and Richard C. Becker, MD, Duke University School of Medicine, Durham, NC and William Wargin, Ph.D., President of PK-PM Associates, LLC.

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 Regados 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

Regados 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, Regados 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, Regados 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 Regados clinical programs may be obtained at www.clinicaltrials.gov.

ABOUT APTAMERS

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 active control agent of pegnivacogin.

More information can be found at www.regadobio.com

Contact: Ellen McDonald, Chief Business Officer, Regado Biosciences,

1-908-580-2113, emcdonald@regadobio.com


Media Contact:

Tiberend Strategic Advisors, Inc.

1-212-827-0020

Andrew Mielach, amielach@tiberendstrategicadvisors.com



SOURCE Regado Biosciences, Inc.


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