A trailblazing neuroprotective drug developed in Western Australia to reduce brain tissue death after stroke is proceeding to the next phase of clinical development.
Perth-based biotechnical company Argenica Therapeutics has received ethics approval for its Phase 2 Clinical Trial of ARG-007 and trial sites will be established in up to ten Australian hospitals.
Patient recruitment and dosing is expected to begin in the first quarter of calendar year 2024.
ARG-007 has been developed through research led by Argenica’s Chief Scientific Officer Professor Bruno Meloni (The University of Western Australia and Head of Stroke Laboratory Research at the Perron Institute), and Clinical Professor Neville Knuckey (Perron Institute and UWA).
“The aim is for ARG-007 to protect brain cells and reduce cell death following an acute ischaemic stroke and other types of neural injury,” said Professor Meloni.
“Ischaemic stroke, where blood flow to the brain is disrupted, is a leading cause of disability and mortality but there are no neuroprotective treatments to minimise the brain damage occurring immediately after a medical emergency of this kind and in the critical following hours.
“The Phase 1 Clinical Trial for ARG-007 confirmed that this novel drug is safe, well tolerated and has a favourable pharmacokinetics profile in healthy volunteers.”
The National Coordinating Principal Investigator of the Phase 2 Clinical Trial is Professor Graeme Hankey, Perron Institute Chair in Stroke Research at UWA.
Hospitals confirmed as participants include Sir Charles Gardiner and Fiona Stanley hospitals in WA; Royal Melbourne Hospital, Monash Medical Centre and Sunshine Hospital in Victoria; Royal Adelaide Hospital, John Hunter and Liverpool hospitals in New South Wales, and Princess Alexandra Hospital in Queensland.
Once site governance is completed at each participating hospital, patients presenting to the emergency department with a confirmed acute ischaemic stroke will be considered for eligibility to participate in the trial.
Eligible patients will then immediately receive either a dose of ARG-007 or a placebo before undergoing a blood clot removing thrombectomy.
Argenica CEO and Managing Director Dr Liz Dallimore said “We are delighted to receive ethics approval for this important proof of concept clinical trial.
“Proving safety and preliminary efficacy in a patient population is a significant milestone and the culmination of over a decade of research work.”