PAH patient is Queensland First in Breakthrough Stroke Drug Trial

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A person points at brain scan images on a computer screen while another person observes, likely discussing medical results.
Dr Meghan Thomas and Dr Michael Devlin

Clinical trials have begun on Queensland patients to test a world-first drug that protects brain tissue from dying following a stroke.

The first clinical trial patient in Queensland has been dosed at the Princess Alexandra Hospital after presenting to the emergency department with a confirmed diagnosis of an acute ischaemic stroke (AIS).

An AIS is caused by a blocked blood vessel to part of the brain; they are the most common type of stroke and make up around 85 per cent of all strokes.

Currently there are no neuroprotective drugs on the market that can protect brain cells from dying following a stroke. If approved Argenica Therapeutics ARG-007 could become a “world-first” drug of global significance.

Argenica’s vice president of Clinical and Regulatory Development Dr Meghan Thomas said the Phase 2 clinical trial of ARG-007 is for patients with AIS in a large vessel in the brain.

“We are absolutely delighted to have the expertise of staff at Brisbane’s Princess Alexandra Hospital and Royal Brisbane and Women’s Hospital stroke units to assist in the running of this clinical trial, with official dosing of our first eligible stroke patient in Queensland at PA Hospital,” said Dr Thomas.

“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, buying them extra critical time,” Dr Thomas said.

“What many people don’t realise is that as soon as a blood vessel is blocked in the brain, brain cells start to die almost immediately,” said Dr Thomas.

“Around 1.9 million brain cells are dying every minute that blood flow is stopped, and that’s why the time frame for receiving a potentially life-saving treatment is so critical.”

LVO strokes account for almost 40 per cent of all acute ischaemic strokes but are responsible for 60 per cent of post-stroke dependency and 90 per cent of deaths after stroke. As a result, LVO strokes are considered the most devastating type of stroke.

Princess Alexandra Hospital Staff Specialist Neurologist, Dr Michael Devlin is the principal investigator for the trial at PA Hospital.

“During the trial, we can administer ARG-007 once someone suspected of having an acute ischaemic stroke is diagnosed in the Emergency Department,” said Dr Devlin.

“The aim of the phase 2 trial is to primarily determine if ARG-007 is well tolerated and safe in patients with AIS and secondarily, to see if it has potential to reduce the amount of brain injury and improve the outcome of patients, compared to placebo.

“We’re excited to offer participation in this trial to our patients. Saving the brain by buying time is the goal. If proven successful, the ability to stop the clock on a stroke even in an ambulance or rural hospital before transfer to a metropolitan hospital would be a revolution in stroke treatment.”

A total of 92 patients will be enrolled in the trial, which will be conducted in 10 hospitals across Australia, including in Queensland, Victoria, New South Wales, Western Australia and South Australia.