Navigation Links
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.

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.

SOURCE Regado Biosciences, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Regado Biosciences Reports Clinical Results for REG1 Anticoagulation System at European Society of Cardiology Congress 2008
2. Regado Biosciences Announces Publication in Circulation of Clinical Trial Results of REG1 Anticoagulation System
3. Regado Biosciences Presents Early Stage Clinical Data for REG1 Anticoagulation System at American Heart Association 2007 Scientific Sessions
4. Regado Biosciences Presents Positive Data From REG1 Anticoagulation System Phase Ic Study at American Heart Association 2007 Scientific Sessions
5. Regado Biosciences Initiates Phase IIa Clinical Study of REG1 Anticoagulation System
6. Ardea Biosciences Presents Preclinical Anti-Inflammatory Data on its Lead MEK Inhibitor, RDEA119, at the ACG 2008 Annual Meeting
7. Epiphany Biosciences to Continue Phase 2 Shingles Study After Interim Analysis; Plans Follow-On Clinical Trial Studying Post-Herpetic Neuralgia (PHN)
8. Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at American College of Gastroenterology Annual Scientific Meeting
9. Sangamo BioSciences Initiates Phase 2 Clinical Trial of Treatment for Amyotrophic Lateral Sclerosis (ALS)
10. Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis
11. Ardea Biosciences Advances Lead Product Candidate for the Treatment of Gout, RDEA594, Into Phase 1 Clinical Trial
Post Your Comments:
(Date:11/25/2015)... 25, 2015 Research and Markets ( ... Market - Global Forecast to 2020" report to ... accounting for 37.21% of the total market share in ... region is projected to growth at the highest ... attributed primarily to the fast growing water, industrial gas ...
(Date:11/24/2015)... November 25, 2015 The hope ... repeated failure of IVF cycles. After failure of over ... and had lost all hopes that she would be able to conceive ever. ... child conceived after failure of over 15 IVF cycles. ... before they decided to take one last attempt with Gaudium IVF ...
(Date:11/24/2015)... , Nov. 24, 2015  Natera, ... in non-invasive genetic testing and the analysis ... it will present at the 27 th ... December 2, 2015 at 1:00 p.m. ET.  Matthew Rabinowitz, Ph.D., ... financial results, business activities and financial outlook. ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... Privately owned Contract Development and Manufacturing ... its current state of the art research, development and manufacturing facility outside of ... manufacturing capacity as well as to support its clients’ growing research and development ...
(Date:11/25/2015)... , ... November 25, 2015 , ... Many people know ... fuzzy-headedness, weight gain, cold hands, and dry skin. But many people who find their ... and exercise regimen instead of their thyroid, especially if they don’t have any of ...
(Date:11/25/2015)... ... November 25, 2015 , ... Since its launch in ... involving adult stem cell therapies to patients with chronic degenerative medical conditions. Now, ... a Registered Trademark (RTM). , Organizations are required to hold a registered trademark ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... prices in an early celebration of the early holiday shopping season. Starting Wednesday ... each (normally $33.95 ea). Black Friday promotional pricing is in addition to any ...
(Date:11/24/2015)... ... November 24, 2015 , ... Eric C. Seidel, DMD ... benefits of the revolutionary BIOLASE WaterLase iPlus 2.0™ system. This advanced laser technology ... by a dentist in Gettysburg, PA . From routine visits to cosmetic ...
Breaking Medicine News(10 mins):