A Phase 2 clinical trial of the revolutionary neuroprotective drug ARG-007 is progressing well, towards a start in the first quarter of 2024.
For the first time, this highly promising therapy will be administered to selected patients who have suffered an acute ischaemic stroke, where blood flow to the brain is disrupted.
Since receiving ethics approval in September 2023, the clinical trial team of Western Australia-based biotechnical company Argenica Therapeutics has been working with several hospitals nationally to establish them as sites for the Phase 2 clinical trial.
Argenica CEO and Managing Director Dr Liz Dallimore said this trial would provide data on the safety and preliminary efficacy of ARG-007 in acute ischaemic stroke patients, paving the way for a pivotal Phase 3 trial and potential partnering with pharmaceutical companies.
“Proving the upscale manufacturing of the clinical grade ARG-007 drug product has been a significant milestone,” Dr Dallimore said.
“Argenica is delighted that manufacturing timelines are on track and is pleased with the progress of research governance at each of the participating hospitals,” she said.
The Phase 2 clinical trial will be conducted in up to 10 Australian hospitals which have dedicated stroke care units able to perform endovascular thrombectomy (minimally invasive surgical removal of a blood clot from a blocked artery in the brain).
ARG-007 has been developed through research led by Professor Bruno Meloni (Perron Institute and The University of Western Australia) and Clinical Professor Neville Knuckey (Perron Institute and UWA).
“As patients enter the emergency department with a suspected acute ischaemic stroke, they will be assessed for eligibility to participate in the trial by the principal investigator neurologist for that trial site,” Professor Meloni said.
“Enrolled patients diagnosed with large vessel occlusion stroke will be randomly assigned to receive either an intravenously (IV) delivered dose of ARG-007 or an IV delivered saline placebo, to be administered before completion of endovascular thrombectomy.”
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.
The Phase 1 clinical trial confirmed that this novel drug is safe and well tolerated in healthy volunteers.
As well as its potential to protect brain cells and reduce cell death following an acute ischaemic stroke, ARG-007 is being investigated for its potential as a neuroprotective therapy for some other neurological conditions, including hypoxic-ischaemic encephalopathy (HIE), a form of brain injury caused by babies being deprived of oxygen before, during or immediately after birth.