Navigation Links
Regado Biosciences Completes Patient Enrollment for Phase IIa Study of REG1 Anticoagulation System
Date:10/14/2008

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:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... GARDENS, N.Y. , Dec. 2, 2016  LifeVac, ... will be included in the Emergency Response Training and ... are very excited to have LifeVac become part of ... Lih , Founder and CEO of LifeVac. "Having an ... LifeVac safely and effectively will help leverage our efforts ...
(Date:12/2/2016)... , Dec. 2, 2016  PipelineRx, a leading medication ... be offering demonstrations of its SaaS-based telepharmacy platform, ... Health-System Pharmacists 2016 Midyear Clinical Meeting and Exhibition, ... . With nearly 300 hospital clients nationally, the ... technology designed to dramatically improve pharmacy operations, enhance ...
(Date:12/2/2016)... AMARILLO, Texas , Dec. 2, 2016  Maxor National ... its acquisition of Pharmaceutical Specialties, Inc. ("PSI").  The combination of ... and Georgia -based PSI bring together both ... patients, physicians, manufacturers, and payers an industry-leading specialty pharmacy. ... , ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... 2016 , ... CloudLIMS.com, a class-leading provider of Laboratory Management ... Lite helps biobanks, clinical, research and testing laboratories keep track of their biospecimens, ... is a faster and a more efficient product, allowing batch processing of data, ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... imaging systems and the first company to offer robotic imaging to veterinary ... their tradeshow booth # 941 for the American Association of Equine Practitioners 62nd ...
(Date:12/2/2016)... ... December 02, 2016 , ... Rijuven Corp launches rejiva ... health, day and night. No other wearable health technology on the market can deliver ... to give poeple more meaningful insights about their health than the usual heart rate ...
(Date:12/2/2016)... ... December 02, 2016 , ... "Pro3rd Accents Volume 2 is ... create versatile lower third titles with just a few clicks of the mouse," said ... includes 30 lower third animations. Choose from various styles with accented animations, rigid boxes, ...
(Date:12/2/2016)... ... December 02, 2016 , ... On ... individuals and families from eight different sites throughout Miami-Dade and Broward counties. This ... volunteers worked very hard on Thanksgiving morning by putting together individual meals via ...
Breaking Medicine News(10 mins):