Perth stroke patients are set to be dosed with a breakthrough Australian-developed drug designed to reduce brain tissue death.
People admitted to hospital emergency departments around the country, including Sir Charles Gairdner and Fiona Stanley hospitals, will be included in the trial.
Currently there are no neuroprotective drugs on the market that can protect brain cells from dying following a stroke, and if approved, ARG-007 could become a “world-first” drug of global significance.
The Phase 2 ‘proof of concept’ clinical trial of ARG-007 is for patients an acute ischaemic stroke, which make up around 85% of all cases, and a total of 92 patients will be enrolled in 10 hospitals across Australia, including WA, NSW, VIC, QLD, and SA.
Argenica Therapeutics managing director and neuroscientist, Dr Liz Dallimore, said the trial was the culmination of more than a decade of Australian research work, and its outcome could prove life-changing for stroke patients across the globe.
“Because our drug is ‘neuroprotective’ essentially what we are trying to do is hibernate the brain cells and protect them from dying until patients can receive treatment to remove the clot,” Dr Dallimore said.
“Around 1.9 million brain cells are dying every minute that blood flow is stopped. During our trial, we can administer ARG-007 once someone suspected of having an acute ischaemic stroke is diagnosed in the emergency department. We will then assess how well our drug is at protecting brain cells from further damage.”
It is hoped ARG-007 will eventually be administered by first responders.
The peptide molecule is based on a linear sequence of an amino acid, arginine, developed in WA at the Perron Institute and UWA.
Argenica has engaged several global leaders in stroke and emergency setting clinical trials to help run the trial, including Professor Graeme Hankey, who is the trial’s national coordinating principal investigator, and Perron Institute Chair in Stroke Research at UWA.
“Phase 1 studies have shown that it is well tolerated and safe in healthy adult human volunteers,” Professor Hankey said.
“Our ultimate goal is to find a safe and accessible treatment that can be given immediately after a stroke and keep dying brain cells alive until, and after, blood flow to the brain is restored.”
Hospitals that have confirmed their participation include:
- Sir Charles Gardiner Hospital and Fiona Stanley Hospital in Western Australia;
- Royal Melbourne Hospital and Monash Medical Centre in Victoria;
- Royal Adelaide Hospital in South Australia;
- John Hunter Hospital and Liverpool Hospital in New South Wales; and
- Princess Alexandra Hospital, Royal Brisbane and Women’s Hospital, and Gold Coast Hospital in Queensland.
“Should the trial meet some or all of its endpoints, Argenica Therapeutics and ARG-007 are likely to garner significant commercial interest from large pharmaceutical companies,” Dr Dallimore said.
“Because this molecule works through a number of different mechanisms, it could be effective against many different illnesses.”
The company has shown ARG-007 has successfully improved outcomes in pre-clinical stroke models, and other neurological conditions including TBI and hypoxic ischaemic encephalopathy).
It has also been shown to prevent aggregation of a key neurodegenerative protein linked to Parkinson’s and Alzheimer’s disease.