Please use this identifier to cite or link to this item: https://repository.monashhealth.org/monashhealthjspui/handle/1/52787
Conference/Presentation Title: Progress update on the phase II, double-blinded, randomised, placebo-controlled study to determine the safety, preliminary efficacy and pharmacokinetics of arg-007 in acute ischemic stroke patients (SEANCON).
Authors: Blacker D.J.;Thomas M.G.;Phillips T.;Donnan G.;Saver J.L.;Dallimore L.;South S.;Knuckey N.W.;Meloni B.P.;Ghia D.;Chemmanam T.;Cheung A.;Cordato D.;Levi C.;Ma H. ;Campbell B.;Wong A. ;Bailey P.;Kleinig T.;Hankey G.J.
Monash Health Department(s): Monash University - School of Clinical Sciences at Monash Health
Institution: (Blacker, Phillips, Bailey, Donnan, Saver) Clinical Advisory Committee, Argenica Therapeutics, Nedlands, WA, Australia
(Blacker, Knuckey, Meloni, Hankey) Perron Institue for Neurological and Translational Science, Nedlands, WA, Australia
(Blacker, Chemmanam) Neurology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia
(Blacker, Ghia) Medicine and Pharmacology, University of Western Australia, Crawley, WA, Australia
(Thomas, Dallimore, South, Meloni) Argenica Therapeutics, Nedlands, WA, Australia
(Phillips) Neurological Intervention and Imaging Service Western Australia, Sir Charles Gairdner Hospital, Fiona Stanley Hospital and Perth Children's Hospital, Perth, WA, Australia
(Bailey) Emergency Medicine, WA Country Health Service, Perth, WA, Australia
(Donnan, Campbell) Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia
(Saver) Department of Neurology, University of California, Los Angeles, United States
(Knuckey, Meloni) Centre for Neuromuscular and Neurological Disorders, University of Western Australia, Nedlands, WA, Australia
(Knuckey, Meloni) Department of Neurosurgery, Sir Charles Gairdner Hospital, Nedlands, WA, Australia
(Ghia) Department of Neurology, Fiona Stanley Hospital, Murdoch, WA, Australia
(Cheung, Cordato) Department of Interventional Neuroradiology, Liverpool Hospital, Liverpool, NSW, Australia
(Cheung, Cordato) South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, Australia
(Cheung, Cordato) Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia
(Levi) Department of Neurology, John Hunter Hospital, Newcastle, NSW, Australia
(Levi) School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia
(Ma) Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash Health, Melbourne, VIC, Australia
(Wong) Department of Neurology and Stroke, Royal Brisbane and Women's Hospital, Herston, QLD, Australia
(Wong) Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia
(Bailey) Department of Neurology, Gold Coast University Hospital, Southport, QLD, Australia
(Kleinig) Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia
(Hankey) Medical School, University of Western Australia, Nedlands, WA, Australia
Presentation/Conference Date: 13-Nov-2024
Copyright year: 2024
Publication information: Cerebrovascular Diseases. Conference: Asia Pacific Stroke Conference 2024 Combined Australian and New Zealand Stroke Organisation Transcending Borders. Adelaide, SA Australia. 53(Supplement 1) (pp 88-89), 2024. Date of Publication: 2024.
Journal: Cerebrovascular Diseases
Abstract: Background: ARG-007 is a cationic poly-arginine peptide consisting of 18 D-arginine residues that is being developed as a cerebroprotective agent in acute ischemic stroke. Extensive pre-clinical studies, a Phase 1 first-in-human study and the plan for the proof-of-concept Phase 2 study in acute ischemic patients (SEANCON) have previously been presented previously at Stroke Society of Australasia (now Australia New Zealand Stroke Organisation, ANZSO). Aim(s): To provide an update on recruitment and progress of the Phase 2 study. Method(s): This trial is a double-blind, placebo-controlled randomised Phase 2 trial. The latest data on screening, recruitment and safety is provided at the time of submission of the abstract, and then updated at the time of presentation. The trial is registered on ANZCTR (ACTRN12623001110673). Result(s): Site selection was finalised by December 2023, with the first 3 sites activated by March 2024 and the remaining 8 sites soon thereafter. The first participant was randomised in March 2024. A total of 10 subjects have been randomised as of May 10, 2024. The independent Data Safety Monitoring Board (DSMB) met for the first time on 22 April, reviewing the first 5 participants. No major issues were identified with the DSMB recommending the trial continued unchanged. Conclusion(s): Early enrolment has progressed well, with no major safety issues identified.
Conference Name: Asia Pacific Stroke Conference 2024 Combined Australian and New Zealand Stroke Organisation Transcending Borders
Conference Start Date: 2024-09-25
Conference End Date: 2024-09-28
Conference Location: Adelaide, SA, Australia
DOI: http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1159/000541320
URI: https://repository.monashhealth.org/monashhealthjspui/handle/1/52787
Type: Conference Abstract
Subjects: cerebrovascular accident
stroke patient
Type of Clinical Study or Trial: Randomised controlled trial
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