Study Supports Dose-dependent Activity of Antidote Component
ORLANDO, Fla., Nov. 4 /PRNewswire/ -- Regado Biosciences today presented data from a randomized, double-blind, placebo-controlled Phase Ic study of the Company's REG1 Anticoagulation System. REG1 is a two-component system comprised of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The study results support RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007. Consistent with previously reported Phase I results, these data were presented by the Duke Clinical Research Institute at the American Heart Association's 2007 Scientific Sessions, currently being held in Orlando, Florida.
Clinical researchers from the Duke Clinical Research Institute and Regado randomized 39 healthy volunteers to receive either three consecutive REG1 treatment cycles or placebo. Each REG1 cycle consisted of an intravenous (IV) bolus of RB006 dosed at 0.75 mg/kg, followed an hour later by a descending dose of RB007, ranging from a 2:1 to 0.125:1 antidote:drug ratio (1.5 mg/kg to 0.094 mg/kg of RB007). Clinical and coagulation assessments were measured for 14 days.
The study showed repeated doses of RB006 achieved highly reproducible increases in activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. Subsequently, repeat doses of RB007 reversed the aPTT levels dose-dependently and reproducibly. There were no major bleeding episodes or other serious adverse events reported in this study.
"I am encouraged by RB007's activity to date in reversing or neutralizing the anticoagulant effect of RB006, either completely or partially, as needed. The potential to modulate coagulation quickly based on the patient's condition represents an advance in anticoagulation therapy that could advance clinical care," said Robert A. Harrington, M.D., Professor of Medicine, Duke University Medical Center, and Director, Duke Clinical Research Institute. "I'm looking forward to seeing data from phase II and phase III studies with the REG1 drug:antidote system."
"The data from the Phase 1c study addressed important questions, particularly regarding the ability to titrate the RB007 component and therefore 'dial down' the anticoagulant effect of RB006," stated Doug Gooding, Chief Executive Officer of Regado Biosciences. "Based upon our Phase I study results, we developed an extensive Phase II program to evaluate REG1 in a variety of coronary revascularization settings. The first study is actively enrolling patients and we expect to initiate several additional studies over the coming months."
REVERSAL-PCI, a multi-center, open-label, randomized Phase IIa clinical study of the REG1 anticoagulation system, will enroll 26 patients undergoing elective percutaneous coronary intervention (PCI) to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting in patients at low risk for complications associated with therapy-related bleeding or heart attack [#msg-24209651].
About REG1 Anticoagulation System
Regado's lead product candidate, REG1, is the first specific, direct- acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at a high-risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.
REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits Factor IXa, a protein that is critical to blood coagulation. The antidote component, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and rapid reversal of RB006 that allows the patient's blood to return to normal.
About Regado Biosciences
Regado Biosciences is pioneering a new therapeutic field with the discovery and development of drug:antidote systems. Regado's drug:antidote systems are designed to give physicians the ability to fine-tune the therapeutic effect desired for each patient and in each setting. A spin-out of the Department of Surgery at Duke University Medical Center, Regado was created to answer the therapeutic needs identified by its scientific founders.
The Company's proprietary platform technology enables the discovery of oligonucleotide-based drug-antidote pairs to any target protein. Regado initially is focusing its discovery and development efforts on the acute care injectable antithrombotics, a multi-billion dollar market in need of therapeutics with improved safety profiles. Potential future indications for Regado's technology include acute coronary syndromes and other coronary revascularization procedures that would benefit from the availability of an antidote-reversible agent. <<
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