Navigation Links
Regado Biosciences Announces First Patient Enrolled in RADAR (Phase 2b) Study of REG1 Anticoagulation System
Date:9/9/2009

BASKING RIDGE, N.J., Sept. 9 /PRNewswire/ -- Regado Biosciences, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, announced that on September 8, 2009 enrollment of the first patient in a Phase 2b, randomized, partially-blinded, multi-center, active-controlled, dose-ranging study of its lead product candidate, the REG1 anticoagulation system (REG1) was achieved. REG1 comprises the selective factor IXa inhibitor, RB006, and its specific active control agent, RB007. The trial, called RADAR, will assess the safety, efficacy, and pharmacodynamics of REG1 compared to unfractionated heparin or low molecular weight heparin in subjects with acute coronary syndromes (ACS). Regado recently successfully completed a phase 2a study of REG1 in stable coronary artery disease patients undergoing elective PCI.

The primary objectives of RADAR will be to determine the clinically acceptable dose range of the specific active control agent, RB007, which can be used to reliably partially or totally reverse the anticoagulant effect of RB006 while reducing bleeding in comparison to heparin, and to determine the pharmacodynamics of the REG1 anticoagulation system in subjects intended for cardiac catheterization within 24 hours who are admitted for ACS-unstable angina and myocardial infarction without ST-segment elevation (UA/NSTEMI).

RADAR, led by principal investigator John H. Alexander, MD, MHS, FACC of Duke University, will enroll 800 subjects at approximately 75 centers around the world. Participating countries include USA, Canada, Poland, France, Germany, Netherlands and Belgium. More information about RADAR can be found at www.clinicaltrials.gov. The identifier for this trial is NCT00932100.

"We are very excited to report the first patient being enrolled in the RADAR study," stated Steven L. Zelenkofske, DO, FACC, Chief Medical Officer of Regado Biosciences. "This event marks a key milestone in the development of this innovative anticoagulation system with its simple yet elegant approach to balancing concomitantly risk reduction of ischemia and bleeding." David J. Mazzo, Ph.D., President and CEO of Regado Biosciences, added, "Successful development of REG1 promises to bring an unprecedented level of control to the physician, ultimately leading to improved outcomes and better safety for patients in the multi-billion dollar worldwide market of antithrombotic therapies."

ABOUT REGADO BIOSCIENCES

Regado Biosciences is pioneering a new therapeutic technology with the creation and development of two-component drug systems. Each system comprises a nuclease-stabilized RNA aptamer that can be controlled directly by its specific and complementary oligonucleotide active control agent. This technology is being applied to injectable antithrombotics, including anticoagulants and antiplatelet agents, a multi-billion dollar market in need of therapeutics with improved safety profiles and a greater degree of therapeutic control. Regado's technology is designed to give physicians the ability to actively and directly control each system's therapeutic effect providing a safe and unique approach to personalized medicine.

ABOUT REG1 and REG2

Regado's lead program, the anticoagulant system REG1, consists of two parenteral agents both administered by IV bolus, the first being a potent highly selective Factor IXa inhibitor (RB006) and the second being its complementary active control agent (RB007). RB007 can be used to selectively completely or partially reverse the anticoagulant effect of RB006. REG1 is intended for application in arterial thrombosis applications, initially in Acute Coronary Syndrome patients undergoing Percutaneous Coronary Intervention. REG2, Regado's second product candidate, consists of a subcutaneously administered formulation of RB006 paired with the IV bolus formulation of RB007. REG2 is intended for use in venous thrombosis indications

ABOUT APTAMERS

RB006 is a member of a class of compounds called aptamers. Aptamers are single stranded oligonucleotides that adopt a specific conformation enabling direct, specific inhibition of the targeted protein. A key unique feature of aptamers derives from the fact that they are formed from nucleic acids. As such, their pharmacologic activity can be controlled by a matched, complementary oligonucleotide active control agent (the Watson-Crick base pair complement of a fraction of the agent to be controlled), which can bind to the aptamer, removing it from its target and reversing it biologic effects.

More information can be found at http://www.regadobio.com.


'/>"/>
SOURCE Regado Biosciences
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Regado Biosciences to Present at 19th Annual Piper Jaffray Health Care Conference
2. Alexander R. Giaquinto, Ph.D., Joins Regado Biosciences as Senior Vice President of Regulatory Affairs and Quality Assurance
3. Regado Biosciences to Present at the 2009 Wharton Healthcare Business Conference
4. Sangamo BioSciences to Present at the ThinkEquity Partners Growth Conference
5. Akers Biosciences, Inc. ABI or the Company Receipt of Further United States Military Contracts
6. Pressure BioSciences to Present at the Rodman & Renshaw BioFin 9th Annual Healthcare Conference in New York City on November 5th
7. Neurocrine Biosciences to Present at the CIBC World Markets 18th Annual Healthcare Conference
8. Pressure BioSciences, Inc. to Discuss Third Quarter Financial Results and Provide Business Update
9. Monogram Biosciences to Present at The Lazard Capital Markets Fourth Annual Healthcare Conference
10. Anaptys Biosciences Raises Over $33 Million in Series B Financing
11. YM BIOSCIENCES REPORTS FIRST QUARTER 2008 OPERATIONAL AND FINANCIAL RESULTS
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... WASHINGTON, DC (PRWEB) , ... April 24, 2017 , ... ... was recognized during ATA 2017: Telehealth 2.0 — the American Telemedicine Association’s annual conference, ... the Santana Telehealth Project for using telemedicine to improve the lives of the poor ...
(Date:4/24/2017)... ... April 24, 2017 , ... NEPC Director Kevin Welner has ... Research Award. The award honors scholars exemplary in their capacity to communicate important ... has demonstrated the capacity to deepen the public’s understanding and appreciation of the ...
(Date:4/24/2017)... ... April 24, 2017 , ... The California Dental Association Foundation’s two-day ... services to 1,961 people during the April 22-23 event at the San Mateo Event ... who experience barriers to care, CDA Cares educates the public and policymakers about the ...
(Date:4/24/2017)... ... , ... The John P. McGovern Museum of Health and Medical Science is ... cognitive health, and share results with their physicians. Members and guests can sign up ... , BrainCheck founder, Dr. David Eagleman, formerly at Baylor College of Medicine and now ...
(Date:4/24/2017)... ... April 24, 2017 , ... My T Chai, a South African ... now available for purchase on RevNutrition.com, a popular website specializing in sales of nutritional ... popularized in ancient India and Siam. It spread across Asia and Africa quickly, and ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... , April 20, 2017  Cogentix Medical, Inc. ... on providing the Urology, Uro/Gyn and Gynecology markets ... Ash Keswani has joined the Company as Senior ... newly created position, Mr. Keswani will report directly ... "Our organization is delighted that Ash ...
(Date:4/20/2017)...  Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), ... it will be participating in the Deutsche Bank Securities ... in Boston, Massachusetts on Wednesday, ... a.m. Eastern Time. A live webcast of ... Relations website at http://investor.zimmerbiomet.com .  The webcast will ...
(Date:4/20/2017)... , April 20, 2017  RXi Pharmaceuticals Corporation ... therapeutics that address significant unmet medical needs, today ... the Company,s consumer product development program, based on ... Society for Investigative Dermatology (SID) 76 th ... and promote the sciences relevant to skin health ...
Breaking Medicine Technology: