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Pegnivacogin

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https://www.readbyqxmd.com/read/27522158/pre-existing-anti-peg-antibodies-are-associated-with-severe-immediate-allergic-reactions-to-pegnivacogin-a-pegylated-aptamer
#1
Thomas J Povsic, Monica G Lawrence, A Michael Lincoff, Roxana Mehran, Christopher P Rusconi, Steven L Zelenkofske, Zhen Huang, Jeffrey Sailstad, Paul W Armstrong, P Gabriel Steg, Christoph Bode, Richard C Becker, John H Alexander, N Franklin Adkinson, Arnold I Levinson
No abstract text is available yet for this article.
July 14, 2016: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/26688515/pre-existing-anti-polyethylene-glycol-antibody-linked-to-first-exposure-allergic-reactions-to-pegnivacogin-a-pegylated-rna-aptamer
#2
Nancy J Ganson, Thomas J Povsic, Bruce A Sullenger, John H Alexander, Steven L Zelenkofske, Jeffrey M Sailstad, Christopher P Rusconi, Michael S Hershfield
No abstract text is available yet for this article.
May 2016: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/26547100/effect-of-the-reg1-anticoagulation-system-versus-bivalirudin-on-outcomes-after-percutaneous-coronary-intervention-regulate-pci-a-randomised-clinical-trial
#3
RANDOMIZED CONTROLLED TRIAL
A Michael Lincoff, Roxana Mehran, Thomas J Povsic, Steven L Zelenkofske, Zhen Huang, Paul W Armstrong, P Gabriel Steg, Christoph Bode, Mauricio G Cohen, Christopher Buller, Peep Laanmets, Marco Valgimigli, Toomas Marandi, Viliam Fridrich, Warren J Cantor, Bela Merkely, Jose Lopez-Sendon, Jan H Cornel, Jaroslaw D Kasprzak, Michael Aschermann, Victor Guetta, Joao Morais, Peter R Sinnaeve, Kurt Huber, Rod Stables, Mary Ann Sellers, Marilyn Borgman, Lauren Glenn, Arnold I Levinson, Renato D Lopes, Vic Hasselblad, Richard C Becker, John H Alexander
BACKGROUND: REG1 is a novel anticoagulation system consisting of pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and anivamersen, a complementary sequence reversal oligonucleotide. We tested the hypothesis that near complete inhibition of factor IXa with pegnivacogin during percutaneous coronary intervention, followed by partial reversal with anivamersen, would reduce ischaemic events compared with bivalirudin, without increasing bleeding. METHODS: We did a randomised, open-label, active-controlled, multicentre, superiority trial to compare REG1 with bivalirudin at 225 hospitals in North America and Europe...
January 23, 2016: Lancet
https://www.readbyqxmd.com/read/25953802/inhibition-of-factor-ixa-by-the-pegnivacogin-system-during-cardiopulmonary-bypass-a-potential-substitute-for-heparin-a-study-in-baboons
#4
Alain Bel, Wasseem Borik, Simon Davidson, Jean-Marie Helies, Lev Stimmer, Stephen Fremes, Steven Zelenkofske, Christopher Rusconi, John Alexander, David Alexander, Philippe Menasché, John Pepper
OBJECTIVES: Heparin and protamine are standard for anticoagulation and reversal for cardiopulmonary bypass (CPB). The REGADO biosciences protocol 1 (REG1) anticoagulant system, consisting of the Factor IXa (FIXa)-inhibitor pegnivacogin and its reversal agent (anivamersen), has been studied in patients undergoing coronary catheterization and in CPB in sheep and pigs. Prior to first human use in CPB, we wanted to test the safety and efficacy of REG1 in a primate model. METHODS: Fourteen baboons undergoing 2 h of CPB followed by 1 h of reperfusion were studied...
February 2016: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/25494843/specific-antidotes-in-development-for-reversal-of-novel-anticoagulants-a-review
#5
REVIEW
Antonio Gomez-Outes, M L Suarez-Gea, Ramon Lecumberri, Ana I Terleira-Fernandez, Emilio Vargas-Castrillon
In the last decade, several direct oral anticoagulants (DOAC; dabigatran, rivaroxaban, apixaban, edoxaban) have been marketed for prophylaxis and/or treatment of thromboembolism without having specific antidotes available for their reversal. Current management of bleeding associated to DOAC includes the removal of all antithrombotic medications and supportive care. Non-specific procoagulant agents (prothrombin complex concentrates and activated factor VIIa) have been used in case of serious bleeding. Currently, some specific antidotes for the DOAC are under development...
2014: Recent Patents on Cardiovascular Drug Discovery
https://www.readbyqxmd.com/read/24929350/use-of-the-reg1-anticoagulation-system-in-patients-with-acute-coronary-syndromes-undergoing-percutaneous-coronary-intervention-results-from-the-phase-ii-radar-pci-study
#6
Thomas J Povsic, John P Vavalle, John H Alexander, Laura H Aberle, Steven L Zelenkofske, Richard C Becker, Christopher E Buller, Mauricio G Cohen, Jan H Cornel, Jaroslaw D Kasprzak, Gilles Montalescot, Peter S Fail, Ian J Sarembock, Roxana Mehran
AIMS: We sought to determine the feasibility of conducting percutaneous coronary intervention (PCI) in high-risk acute coronary syndrome (ACS) patients utilising the REG1 system consisting of pegnivacogin, an aptameric factor IXa inhibitor, and its controlling agent anivamersen. METHODS AND RESULTS: In RADAR, ACS patients were randomised to pegnivacogin 1 mg/kg with 25%, 50%, 75%, or 100% anivamersen reversal or unfractionated heparin. Of the 640 patients randomised, 388 (61%) underwent PCI...
August 2014: EuroIntervention
https://www.readbyqxmd.com/read/24880800/the-effect-of-the-reg2-anticoagulation-system-on-thrombin-generation-kinetics-a-pharmacodynamic-and-pharmacokinetic-first-in-human-study
#7
RANDOMIZED CONTROLLED TRIAL
J P Vavalle, C P Rusconi, S Zelenkofske, W A Wargin, T L Ortel, J H Alexander, T J Povsic, R C Becker
The REG2 Anticoagulation System consists of pegnivacogin, a subcutaneously administered aptamer factor IXa inhibitor, and its intravenous active control agent, anivamersen. Its effect on thrombin generation is unknown. A prospectively designed thrombin generation study was conducted within the phase 1 ascending dose study of REG2 to assess the effect of REG2 on thrombin generation kinetics. A total of 32 healthy volunteers were recruited into four cohorts of ascending dose pegnivacogin for the phase 1 study...
October 2014: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/24338703/role-of-novel-and-emerging-oral-anticoagulants-for-secondary-prevention-of-acute-coronary-syndromes
#8
REVIEW
Valerie S Ganetsky, Diane E Hadley, Tyan F Thomas
Dual antiplatelet therapy has become a mainstay of long-term management of patients after an acute coronary syndrome (ACS). Mortality for these patients remains high despite current evidence-based treatment strategies. The coagulation cascade plays a role in the pathophysiology of ACS, and trials with warfarin in combination with dual antiplatelet therapy have found decreased rates of ischemic events at the expense of increased bleeding risk. Novel oral anticoagulants (NOACs) in the direct factor Xa (FXa) inhibitor and direct thrombin inhibitor (DTI) categories have been evaluated in combination with standard post-ACS therapy...
June 2014: Pharmacotherapy
https://www.readbyqxmd.com/read/22859796/a-phase-2-randomized-partially-blinded-active-controlled-study-assessing-the-efficacy-and-safety-of-variable-anticoagulation-reversal-using-the-reg1-system-in-patients-with-acute-coronary-syndromes-results-of-the-radar-trial
#9
RANDOMIZED CONTROLLED TRIAL
Thomas J Povsic, John P Vavalle, Laura H Aberle, Jaroslaw D Kasprzak, Mauricio G Cohen, Roxana Mehran, Christoph Bode, Christopher E Buller, Gilles Montalescot, Jan H Cornel, Andrzej Rynkiewicz, Michael E Ring, Uwe Zeymer, Madhu Natarajan, Nicolas Delarche, Steven L Zelenkofske, Richard C Becker, John H Alexander
AIMS: We sought to determine the degree of anticoagulation reversal required to mitigate bleeding, and assess the feasibility of using pegnivacogin to prevent ischaemic events in acute coronary syndrome (ACS) patients managed with an early invasive approach. REG1 consists of pegnivacogin, an RNA aptamer selective factor IXa inhibitor, and its complementary controlling agent, anivamersen. REG1 has not been studied in invasively managed patients with ACS nor has an optimal level of reversal allowing safe sheath removal been defined...
August 2013: European Heart Journal
https://www.readbyqxmd.com/read/22500821/a-phase-1-ascending-dose-study-of-a-subcutaneously-administered-factor-ixa-inhibitor-and-its-active-control-agent
#10
RANDOMIZED CONTROLLED TRIAL
J P Vavalle, C P Rusconi, S Zelenkofske, W A Wargin, J H Alexander, R C Becker
BACKGROUND: The REG2 anticoagulation system consists of pegnivacogin, a subcutaneously administered aptamer factor IXa inhibitor, and its intravenous control agent, anivamersen. OBJECTIVES: To assess the safety, tolerability and pharmacokinetic and pharmacodynamic responses of REG2. PATIENTS/METHODS: In this phase 1a study, 36 healthy volunteers were enrolled into five cohorts and given one dose of pegnivacogin. Cohorts 1 (n = 6) and 1A (n = 4) received 0...
July 2012: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/21724623/pegnivacogin-results-in-near-complete-fix-inhibition-in-acute-coronary-syndrome-patients-radar-pharmacokinetic-and-pharmacodynamic-substudy
#11
RANDOMIZED CONTROLLED TRIAL
Thomas J Povsic, William A Wargin, John H Alexander, Joshua Krasnow, Merill Krolick, Mauricio G Cohen, Roxana Mehran, Christopher E Buller, Christoph Bode, Steven L Zelenkofske, Christopher P Rusconi, Richard C Becker et al.
AIMS: Establishing factor IX inhibition in patients with acute coronary syndrome/non-ST-elevation myocardial infarction (ACS/NSTEMI), a setting characterized by increased factor IX activity, is critical to investigate the REG1 system in this target population. The REG1 system (Regado Biosciences, Basking Ridge, NJ) consists of pegnivacogin (RB006), an RNA aptamer that directly inhibits factor IXa, and anivamersen (RB007), its complementary control agent. METHODS AND RESULTS: RADAR is a Phase 2b study investigating the use of pegnivacogin in patients (n = 800) with ACS undergoing planned early cardiac catheterization...
October 2011: European Heart Journal
https://www.readbyqxmd.com/read/21503856/dose-selection-for-a-direct-and-selective-factor-ixa-inhibitor-and-its-complementary-reversal-agent-translating-pharmacokinetic-and-pharmacodynamic-properties-of-the-reg1-system-to-clinical-trial-design
#12
MULTICENTER STUDY
T J Povsic, M G Cohen, M Y Chan, S L Zelenkofske, W A Wargin, R A Harrington, J H Alexander, C P Rusconi, R C Becker
We performed detailed pharmacokinetic and pharmacodynamic modeling of REG1, an anticoagulation system composed of the direct factor IXa (FIXa) inhibitor pegnivacogin (RB006) and its matched active control agent anivamersen (RB007), with a focus on level of target inhibition to translate phase 1 results to phase 2 dose selection. We modeled early-phase clinical data relating weight-adjusted pegnivacogin dose and plasma concentration to prolongation of the activated partial thromboplastin time (aPTT). Using an in vitro calibration curve, percent FIXa inhibition was determined and related to aPTT prolongation and pegnivacogin dose and concentration...
July 2011: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/21315207/a-randomized-partially-blinded-multicenter-active-controlled-dose-ranging-study-assessing-the-safety-efficacy-and-pharmacodynamics-of-the-reg1-anticoagulation-system-in-patients-with-acute-coronary-syndromes-design-and-rationale-of-the-radar-phase-iib-trial
#13
RANDOMIZED CONTROLLED TRIAL
Thomas J Povsic, Mauricio G Cohen, Roxana Mehran, Christopher E Buller, Christoph Bode, Jan H Cornel, Jarosław D Kasprzak, Gilles Montalescot, Diane Joseph, William A Wargin, Christopher P Rusconi, Steven L Zelenkofske, Richard C Becker, John H Alexander
Anticoagulants are the cornerstone of current acute coronary syndrome (ACS) therapy; however, anticoagulation regimens that aggressively reduce ischemic events are almost uniformly associated with more bleeding. REG1, an anticoagulation system, consists of RB006 (pegnivacogin), an RNA oligonucleotide factor IXa inhibitor, and RB007 (anivamersen), its complementary controlling agent. Phase I and IIa studies defined predictable relationships between doses of RB006, RB007, and degree of antifactor IX activity...
February 2011: American Heart Journal
https://www.readbyqxmd.com/read/21080135/translating-nucleic-acid-aptamers-to-antithrombotic-drugs-in-cardiovascular-medicine
#14
REVIEW
Thomas J Povsic, Bruce A Sullenger, Steven L Zelenkofske, Christopher P Rusconi, Richard C Becker
Nucleic acid aptamers offer several distinct advantages for the selective inhibition of protein targets within the coagulation cascade. A highly attractive feature of aptamers as antithrombotics is their ability to encode for complementary "controlling agents" which selectively bind to and neutralize their active counterparts via Watson-Crick base pairing or, in a less selective and clinically characterized manner, cationic polymers that can counteract the activity of an aptamer or free/protein-complexed nucleic acid...
December 2010: Journal of Cardiovascular Translational Research
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