Navigation Links
Regado Biosciences Presents Positive Data From REG1 Anticoagulation System Phase Ic Study at American Heart Association 2007 Scientific Sessions

Study Supports Dose-dependent Activity of Antidote Component

ORLANDO, Fla., Nov. 4 /PRNewswire/ -- Regado Biosciences today presented data from a randomized, double-blind, placebo-controlled Phase Ic study of the Company's REG1 Anticoagulation System. REG1 is a two-component system comprised of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The study results support RB007's ability to reverse the anticoagulant effect of RB006 either completely or partially, depending on the level of dosing of RB007. Consistent with previously reported Phase I results, these data were presented by the Duke Clinical Research Institute at the American Heart Association's 2007 Scientific Sessions, currently being held in Orlando, Florida.

Clinical researchers from the Duke Clinical Research Institute and Regado randomized 39 healthy volunteers to receive either three consecutive REG1 treatment cycles or placebo. Each REG1 cycle consisted of an intravenous (IV) bolus of RB006 dosed at 0.75 mg/kg, followed an hour later by a descending dose of RB007, ranging from a 2:1 to 0.125:1 antidote:drug ratio (1.5 mg/kg to 0.094 mg/kg of RB007). Clinical and coagulation assessments were measured for 14 days.

The study showed repeated doses of RB006 achieved highly reproducible increases in activated partial thromboplastin time (aPTT), a well-accepted surrogate marker of the blood's ability to clot. Subsequently, repeat doses of RB007 reversed the aPTT levels dose-dependently and reproducibly. There were no major bleeding episodes or other serious adverse events reported in this study.

"I am encouraged by RB007's activity to date in reversing or neutralizing the anticoagulant effect of RB006, either completely or partially, as needed. The potential to modulate coagulation quickly based on the patient's condition represents an advance in anticoagulation therapy that could advance clinical care," said Robert A. Harrington, M.D., Professor of Medicine, Duke University Medical Center, and Director, Duke Clinical Research Institute. "I'm looking forward to seeing data from phase II and phase III studies with the REG1 drug:antidote system."

"The data from the Phase 1c study addressed important questions, particularly regarding the ability to titrate the RB007 component and therefore 'dial down' the anticoagulant effect of RB006," stated Doug Gooding, Chief Executive Officer of Regado Biosciences. "Based upon our Phase I study results, we developed an extensive Phase II program to evaluate REG1 in a variety of coronary revascularization settings. The first study is actively enrolling patients and we expect to initiate several additional studies over the coming months."

REVERSAL-PCI, a multi-center, open-label, randomized Phase IIa clinical study of the REG1 anticoagulation system, will enroll 26 patients undergoing elective percutaneous coronary intervention (PCI) to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilatation and stenting in patients at low risk for complications associated with therapy-related bleeding or heart attack.

About REG1 Anticoagulation System

Regado's lead product candidate, REG1, is the first specific, direct- acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at a high-risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.

REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 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 antidote component, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and rapid reversal of RB006 that allows the patient's blood to return to normal.

About Regado Biosciences

Regado Biosciences is pioneering a new therapeutic field with the discovery and development of drug:antidote systems. Regado's drug:antidote systems are designed to give physicians the ability to fine-tune the therapeutic effect desired for each patient and in each setting. A spin-out of the Department of Surgery at Duke University Medical Center, Regado was created to answer the therapeutic needs identified by its scientific founders.

The Company's proprietary platform technology enables the discovery of oligonucleotide-based drug-antidote pairs to any target protein. Regado initially is focusing its discovery and development efforts on the acute care injectable antithrombotics, a multi-billion dollar market in need of therapeutics with improved safety profiles. Potential future indications for Regado's technology include acute coronary syndromes and other coronary revascularization procedures that would benefit from the availability of an antidote-reversible agent.

SOURCE Regado Biosciences
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
2. YM BioSciences Announces Preclinical Data Confirming Nimotuzumab Binds to the EGF Receptor and Potentiates Radiotherapy
3. Sangamo BioSciences Announces Presentation of Phase 1 ZFP Therapeutic Data at American Diabetes Association Meeting
4. Neurocrine Biosciences Announces New Research Studies Presented at APSS Reveal Significant Under-Diagnosis of Insomnia
5. Hana Biosciences Presents Data On Two Programs At the American Society of Clinical Oncology Annual Meeting
6. IR BioSciences Announces Promising Data from Study of Its Compound Homspera
7. Sangamo BioSciences Announces Presentation of ZFP Therapeutic Data From Nerve Regeneration Program at American Society for Neural Therapy and Repair Meeting
8. Lux Biosciences Investigational Therapy for Uveitis, LX211, is Subject of Two Presentations at Key Ophthalmology Meeting, ARVO 2007
9. YM BioSciences Reports AeroLEF Randomized Phase IIb Trial Meets Primary Endpoint in Patients with Post-Surgical Pain
10. Hana Biosciences Announces Data to be Presented On Talvesta (Talotrexin) for Injection at The American Association for Cancer Research Annual Meeting
11. Ace Biosciences, Ace393, the Worlds First Commercial Vaccine for Travellers Diarrhoea Caused by Campylobacter Successfully Completes Phase I Clinical Trials
Post Your Comments:
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... 2016 The vast majority of dialysis patients ... Treatments are usually 3 times a week, with treatment ... travel time, equipment preparation and wait time.  This regimen ... for patients who are elderly and frail.  Many elderly ... rehabilitation centers for some duration of time. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell ... pain and the benefits of holistic treatments, Serenity Recovery Center of Marne, ... Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood ...
Breaking Medicine News(10 mins):