Replies to post #66198 on Biotech Values

[HobGlobulin]

Regado Completes PIIa Enrollment for its Anticoagulant & Reversal Agent

http://genengnews.com/news/bnitem.aspx?name=43525062&taxid=0

>> Oct 14 2008, 3:30 AM EST

Regado Biosciences Completes Patient Enrollment for Phase IIa Study of REG1 Anticoagulation System

DURHAM, N.C., Oct. 10 /PRNewswire/ -- Regado Biosciences, Inc., announced today the Company has completed enrollment in the Phase IIa clinical study of its REG1 Anticoagulation System in patients undergoing elective percutaneous coronary intervention (PCI). REG1 is a two-component system composed of an aptamer-based anticoagulant, RB006, and its matched, active reversal agent, RB007, which specifically binds to and neutralizes RB006. The Phase IIa study (REVERSAL-PCI) is designed to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting on patients at low risk for complications associated with therapy-related bleeding or heart attack.

REVERSAL-PCI, a multi-center, open-label, randomized clinical study, has enrolled a total of 26 patients. All patients were pretreated with clopidogrel and aspirin to inhibit platelet activity and were then randomized to receive either REG1 or unfractionated heparin. In patients treated with the REG1 System, RB006 was used as the sole anticoagulant during the procedure. Following the procedure, RB007 was used to reverse the effects of RB006 with the goal of facilitating early sheath removal. Primary procedural success in the trial is defined by the absence of significant bleeding events up to hospital discharge or 48 hours post stenting, and by the absence of death, nonfatal heart attack, or need to repeat revascularization up to day 14.

David J. Mazzo, Ph.D., President and Chief Executive Officer of Regado Biosciences, stated, "The Phase IIa trial is designed to build on extensive Phase I results demonstrating, among other things, that RB006 safely and effectively inhibited the activity of factor IXa, an essential blood clotting protein, and that RB007 rapidly, safely and specifically reversed the activity of RB006. We are pleased to have reached this milestone in our clinical program and look forward to continued progress in the coming months."

About REG1 Anticoagulation System

The REG1 system consists of the first specific, direct-acting anticoagulant controllable by a matched reversal agent. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), put patients at a high risk for therapy-related bleeding complications. REG1 is being developed initially to increase safety and therapeutic flexibility as well as to improve patient outcomes in coronary revascularization procedures.

REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched reversal agent. The 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 reversal agent, RB007, is a complementary nucleic acid that specifically binds to and neutralizes RB006. The amount of RB007 administered allows physicians to rapidly fine tune the pharmacodynamic effect of RB006, from slight reduction in anticoagulation all the way to complete reversal.[Like playing a violin?]

About Regado Biosciences

Regado Biosciences is pioneering a new therapeutic field with the discovery and development of two-component drug systems, comprising an aptamer therapeutic that can be controlled directly by a specific and matched reversal agent. Regado's technology is designed to give physicians the ability to directly control and fine tune each product's therapeutic effect. This control and flexibility allows physicians to meet the individual needs of each patient independent of the setting. Regado initially is focusing its discovery and development efforts on acute care injectable antithrombotics, a multi-billion dollar market in need of therapeutics with improved safety profiles.

Current investors in Regado include Domain (Princeton, NJ), Quaker BioVentures (Philadelphia, PA), Aurora Funds (Durham, NC) and Caxton Advantage Life Sciences Fund (New York, NY), as well as individual investors, including Robert Kierlin. <<

[RockRat]

Some analysts think this is the nearest thing to Momenta's M118, these are the P2a results:

>>First Clinical Application of an Actively Reversible Direct Factor IXa Inhibitor as an Anticoagulation Strategy in Patients Undergoing Percutaneous Coronary Intervention

Mauricio G. Cohen, MD; Drew A. Purdy, MD; Joseph S. Rossi, MD, MHS; Liliana R. Grinfeld, MD; Shelley K. Myles, BS; Laura H. Aberle, BSPH; Adam B. Greenbaum, MD; Edward Fry, MD; Mark Y. Chan, MD; Ross M. Tonkens, MD; Steven Zelenkofske, DO; John H. Alexander, MD, MHS; Robert A. Harrington, MD; Christopher P. Rusconi, PhD; Richard C. Becker, MD

From the Cardiovascular Division, University of Miami Miller School of Medicine, Miami, Fla (M.G.C.); Black Hills Cardiology, Rapid City, SD (D.A.P.); Division of Cardiology, University of North Carolina at Chapel Hill (J.S.R.); Hospital Italiano de Buenos Aires, Buenos Aires, Argentina (L.R.G.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.K.M., L.H.A., M.Y.C., J.H.A., R.A.H., R.C.B.); Henry Ford Heart and Vascular Institute, Detroit, Mich (A.B.G.); The Care Group, Indianapolis, Ind (E.F.); and Regado Biosciences, Inc, Basking Ridge, NJ (R.M.T., S.Z., C.P.R.).

Correspondence to Mauricio G. Cohen, MD, Cardiovascular Division, University of Miami Miller School of Medicine, 1400 NW 12th Ave, Suite 1179, Miami, FL 33136. E-mail [e-mail]

Received December 1, 2009; accepted June 1, 2010.

Background— The ideal anticoagulant should prevent ischemic complications without increasing the risk of bleeding. Controlled anticoagulation is possible with the REG1 system, an RNA aptamer pair comprising the direct factor IXa inhibitor RB006 and its active control agent RB007.

Methods and Results— This phase 2a study included a roll-in group (n=2) treated with REG1 plus glycoprotein IIb/IIIa inhibitors followed by 2 groups randomized 5:1 to REG1 or unfractionated heparin. In group 1 (n=12), RB006 was partially reversed with RB007 after percutaneous coronary intervention and fully reversed 4 hours later. In group 2 (n=12), RB006 was fully reversed with RB007 immediately after percutaneous coronary intervention. Femoral sheaths were removed after complete reversal. Patients were pretreated with aspirin and clopidogrel. End points included major bleeding within 48 hours; composite of death, myocardial infarction, or urgent target vessel revascularization within 14 days; and pharmacodynamic measures. All cases were successful, with final Thrombolysis in Myocardial Infarction grade 3 flow and no angiographic thrombotic complications. There were 2 ischemic end points in the REG1 group and 1 in the unfractionated heparin group, with 1 major bleed in the unfractionated heparin group. Median activated clotting time values rose from 151 to 236 seconds after RB006. Administration of the partial RB007 dose reversed anticoagulation to an intermediate activated clotting time value of 186 seconds. Complete reversal with RB007 returned the median activated clotting time value to 144 seconds. Both reversal strategies enabled scheduled femoral sheath removal.

Conclusions— This study demonstrates the clinical translation of a novel platform of anticoagulation targeting factor IXa and its active reversal to percutaneous coronary intervention and provides the basis for further investigation.<<

I assume Regado would also try to partner after P2b -- now enrolling -- is completed. They have also started a P1 with a sub q formulation for venous thrombosis indications.

Regards, RockRat