An advanced clinical trial assessing the safety of the neuroprotective drug ARG-007 in patients who have experienced acute ischemic stroke (AIS) is continuing to plan.
Dosing of patients in eight of the ten participating hospitals across Australia has occurred, representing 86 per cent of the sample required for the Phase 2 trial.
Stroke is a critical global health challenge, occurring approximately every 11 minutes in Australia, with enormous personal, community and economic burdens.
The trial of the novel drug to limit brain tissue death after stroke and other neurological conditions is being led by biotechnical company Argenica Therapeutics, based on a world-leading discovery by a research team led by Clinical Professor Neville Knuckey and Professor Bruno Meloni (Perron Institute and The University of Western Australia).
In stroke, the new therapy could potentially extend the therapeutic time window for medical interventions such as blood clot removal, ultimately preserving brain tissue and improving patient outcomes.
“With the strong rate of recruitment, Argenica anticipates that the dosing of all patients will be completed early in the second quarter of (calendar year) 2025,” said Managing Director Dr Liz Dallimore.
“Based on results so far, the independent Data Safety Monitoring Board (DSMB) which monitors for any adverse events, has recommended that the Phase 2 clinical trial of ARG-007 in AIS patients continues with no modifications to the study protocol required.
“This represents a significant milestone as we near completion of patient dosing and Argenica thanks the independent members of the DSMB for their dedication and commitment to this study.
“We expect topline data from the trial to be provided within weeks of the final 90 day follow up of patients dosed,” Dr Dallimore said.
Professor Graeme Hankey, Perron Institute Chair in Stroke at UWA, is the National Coordinating Principal Investigator of the Phase 2 Clinical Trial.
Based on an Argenica Therapeutics media statement