Regado Biosciences Presents Early Stage Clinical Data for REG1 Anticoagulation System at American Heart Association 2007 Scientific Sessions
"These Phase I results are encouraging, and this system should beevaluated further in confirmatory Phase II and III clinical studies.Experienced clinicians recognize the importance of being able to titrate theintensity of anticoagulation according to specific patient needs. Currentdrugs do not offer an optimal level of control or flexibility," said RichardC. Becker, M.D., Professor of Medicine, Duke University Medical Center, andDirector, Duke Cardiovascular Thrombosis Center, Duke Clinical ResearchInstitute. "Should additional well-controlled clinical studies confirm thesedata, REG1 may have potential for broad applications in clinical practicesettings from the emergency room to the operating room."
Scientists from the Duke Clinical Research Institute and Regado analyzedREG1 pharmacokinetics and dosing data from 134 subjects enrolled in two of thethree Phase I studies. The Phase Ia study enrolled 84 healthy volunteers; thePhase Ib study enrolled 50 patients with stable coronary artery disease whowere receiving aspirin with or without clopidogrel. The results of theanalysis showed an intravenous (IV) bolus injection of RB006 achieved in bothstudy populations a prompt, consistent, and dose-dependent prolongation ofactivated partial thromboplastin time (aPTT), a well-accepted surrogate markerof the blood's ability to clot. In addition, a 1 mg/kg dose of RB006 resultedin 100 percent Factor IXa inhibition. The studies also demonstrated an IVbolus injection of RB007 administered in a 2:1 antidote:drug ratiosuccessfully reversed prolonged aPTT within a median of one minute, with norebound increase up to seven days. Despite dual antiplatelet use in 19subjects, there were no major bleeding or other serious adverse eventsobserved in either study.
"Our Phase I studies consistently have confirmed the two major attributesof the REG1 system, the ability to rapidly anticoagulate and then reverse thiseffect," stated Doug Gooding, Chief Executive Officer of Regado Biosciences."We are confident later-stage clinical testing will further confirm our beliefREG1 has the potential to be a first-in-class antidote-reversible therapeuticsystem, which could transform the way anticoagulation is approached incoronary revascularization procedures and other acute care settings."
REVERSAL-PCI, a multi-center, open-label, randomized Phase IIa clinicalstudy of the REG1 anticoagulation system, is enrolling 26 patients undergoingelective percutaneous coronary intervention (PCI) to assess whether REG1 canreplace standard heparin therapy during the performance of coronary balloonangioplasty dilatation and stenting in patients at low risk for complicationsassociated with therapy-related bleeding or heart attack.
About REG1 Anticoagulation System
Regado's lead product candidate, REG1, is the first specific,direct-acting, antidote-controlled anticoagulant ever described. Regado isdeveloping REG1 for use in patients suffering from acute coronary syndrome whoundergo coronary revascularization procedures. These procedures, whichinclude coronary artery bypass grafting (CABG) and percutaneous coronaryintervention (PCI), put patients at a high-risk for therapy-related bleeding
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