Regado Biosciences, Inc. Presents Positive Efficacy and Safety Substudy Data from the Phase 2b RADAR Trial for the REG1 Anticoagulation System at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium 2011
BASKING RIDGE, N.J., Nov. 7, 2011 /PRNewswire/ -- Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced the presentation of two posters highlighting positive substudy results of the Company's Phase 2b RADAR trial of REG1, Regado's proprietary anticoagulation system. The posters will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium meeting on November 8, 2011 from 8:00-10:00 a.m. PST in San Francisco, CA.
"The Phase 2b RADAR trial for REG1 has demonstrated a paradigm shift to provide physicians with a more effective option to control bleeding and ischemic events in ACS patients. REG1 provides physicians the ability to titrate the intensity of anticoagulation according to specific patient needs, which are not currently met with existing drugs," said Dr. Mauricio Cohen, director of the cardiac catheterization laboratory at the University of Miami Miller School of Medicine and a lead investigator of the study, who will present the data. "We're delighted to have the opportunity to share further analyses of these groundbreaking results among our peers."
The posters are titled "Use of the REG1 Anticoagulation System During PCI May Improve Bleeding and Ischemic Complications Compared with Heparin: A PCI Substudy from the Phase 2b RADAR Trial" and "Access and non-Access Site Bleeding in Acute Coronary Syndrome Patients Treated with a Novel Actively Reversible Factor IXa Inhibitor: Results from the RADAR Trial."
REG1 is a two-component system consisting of pegnivacogin (a.k.a. RB006), a direct Factor IXa inhibitor, and anivamersen (a.k.a. RB007), its complementary active control agent. The RADAR clinical trial demonstrated that REG1 provided nearly complete Factor IXa inhibition followed by 75% and 100% reversal, resulting in numerically lower rates of ischemic events when compared with heparin. The results of RADAR support further development of REG1 in adequately powered clinical trials to assess the safety and efficacy of controllable anticoagulation.
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 active control agent of pegnivacogin.
More information can be found at www.regadobio.com.
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SOURCE Regado Biosciences, Inc.