Western Australian based biotechnical company Argenica Therapeutics has announced the successful recruitment of the first five patients in the Phase 2 Clinical Trial of a novel therapeutic to reduce brain tissue death after stroke.
The neuroprotective drug, ARG-007, was developed through research led by Professor Bruno Meloni and Clinical Professor Neville Knuckey at the Perron Institute and The University of Western Australia.
The patients met the criteria for enrolment in the trial after presenting to the emergency departments of Royal Melbourne and Princess Alexandra hospitals with acute ischaemic stroke caused by blockage of a major brain artery.
Up to ten hospitals across Australia will participate in the trial. Each has a dedicated stroke care unit capable of performing endovascular thrombectomy, a minimally invasive surgical procedure to remove a blood clot from a blocked artery.
“No adverse events were reported and a comprehensive review of the safety data has been completed by the independent Data Safety Monitoring Board,” said Argenica Managing Director Dr Liz Dallimore.
“To achieve dosing of the first safety cohort within two weeks of trial start is a testament to the dedication of the clinical trial teams working in the emergency departments.
“As this is a blinded clinical trial, hospital and Argenica staff do not know which of the patients received ARG-007 or the placebo.
“Proving ARG-007 is safe in acute ischaemic stroke patients will pave the way for Argenica to progress to a pivotal Phase 3 trial and further engage with global pharmaceutical companies.
“The trial is designed also to generate preliminary data on ARG-007’s ability to reduce brain tissue death following stroke and thrombectomy to remove a clot from a brain artery.
“Proving ARG-007 is safe in stroke patients and showing preliminary neuroprotective efficacy will be a significant de-risking milestone, with the opportunity to place Argenica at the forefront of neuroprotective clinical validation,” Dr Dallimore said.
The four hospitals activated and able to dose patients are The Royal Melbourne Hospital, Princess Alexandra Hospital, John Hunter Hospital and Liverpool Hospital. Royal Adelaide Hospital and Royal Brisbane and Women’s Hospital have undergone site initiation visits and will be activated imminently. The remaining four hospitals will be activated over the next three months following governance approval.
Professor Graeme Hankey, Perron Institute Chair in Stroke at UWA, is the National Coordinating Principal Investigator of the Phase 2 Clinical Trial.