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:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Issue 52" report to their offering. ... treatment creates a favourable commercial environment for MedImmune to enter. ... base that will serve to drive considerable growth for effective ... serve to cap sales considerably, but development is still in ...
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening to conquer ... in advanced audiology and hearing aid technology, has today ... world,s first internet connected hearing aid that opens up ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... , TwinLink™ - the first dual communication ...
Breaking Medicine Technology: