Regado Biosciences, Inc. Presents the First Clinical Experience with REG2, its Second Product Candidate, at the Arteriosclerosis, Thrombosis and Vascular Biology Scientific Sessions in San Francisco, CA on April 9, 2010.

 

BASKING RIDGE, N.J., April 9 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced that Steven Zelenkofske, DO, FACC, Senior Vice President, Chief Medical Officer, presented an abstract at the Arteriosclerosis, Thrombosis and Vascular Biology Scientific Sessions on April 9, 2010 at 5pm (PST) in San Francisco, CA. The poster, entitled "Subcutaneous RB006, a Direct FIXa Inhibitor Provides Prolonged Anticoagulation with Rapid Reversal; the First Clinical Experience with the REG2 System" is the initial presentation of top-line data from Regado's REG2-SC101 phase 1 study of the REG2 anticoagulation system. The REG2 system is Regado's second product candidate in development, which consists of a subcutaneously administered formulation of the specific Factor IXa inhibitor, RB006, paired with an IV bolus formulation of its complementary active control agent, RB007.
 

The abstract is coauthored by Christopher P. Rusconi, PhD, Steven L. Zelenkofske, DO and Carolyn M. Darmiento, MS, from Regado Biosciences, Richard Becker, MD, Duke University School of Medicine, Durham, NC, William Wargin, PhD, PK-PM Consultants, and Matthew Medlock, MD, PPD, Austin Texas. Dr. Zelenkofske stated: "Because no prior human experience with a subcutaneous aptamer exists, we were pleased that the REG2 system provided prolonged anticoagulation after single injection with rapid reversibility. This may provide a new approach to sub-acute anticoagulation for future clinical applications." Dr. David J. Mazzo, Regado Biosciences' CEO and President added: "Regado Biosciences has a comprehensive antithrombotic pipeline which reflects the company's expertise in the discovery and development of therapeutic aptamers with active control agents in both arterial and venous thrombosis. The data from our REG2-SC101 phase 1 study is encouraging and supports our continued focus in venous thrombosis".
 

ABOUT REGADO BIOSCIENCES
 

Regado Biosciences is pioneering a new therapeutic technology with the creation and development of two-component drug systems. Each system comprises a nuclease-stabilized RNA aptamer that can be controlled directly 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 setting, a multi-billion dollar market in need of therapeutics with improved safety profiles and a greater degree of therapeutic control. Regado's technology is designed to give physicians the ability to actively and directly control each system's therapeutic effect providing a safe and unique approach to personalized medicine.
 

ABOUT REG1 and REG2
 

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 (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. REG1, presently in phase 2b clinical trial, is intended for application in arterial thrombosis applications, initially in Acute Coronary Syndrome patients undergoing Percutaneous Coronary Intervention. REG2, Regado's second product candidate, consists of a subcutaneously administered depot formulation of RB006 paired with the IV bolus formulation of RB007. 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 later in 2010. It is intended for use in venous thrombosis indications such as venous thromboembolism (VTE) prophylaxis in patients undergoing abdominal surgery. Information pertaining to Regado's clinical programs may be obtained at www.clinicaltrials.gov.
 

ABOUT APTAMERS
 

RB006 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 it biologic effects.
 

More information can be found at www.regadobio.com
 

Source: Regado Biosciences, Inc.

CONTACT: Ellen McDonald, Chief Business Officer, Regado Biosciences,
+1-908-580-2113, emcdonald@regadobio.com
 

Web Site: http://www.regadobio.com/
 

Posted: April 2010

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