University of Western Australia
The first clinical trial is under way for a novel neuroprotective drug developed in Western Australia to reduce brain tissue death after ischemic stroke.
The Phase 1 trial is testing the safety, tolerability and pharmacokinetic effects of the drug in healthy human volunteers.
The novel neuroprotective peptide drug candidate was developed by researchers at the Western Australian-based Perron Institute and The University of Western Australia.
Image: Professors Bruno Meloni.
ARG-007, as it is known, developed by Professors Bruno Meloni and Neville Knuckey and their team, has been shown to improve outcomes in a number of preclinical models.
An ischemic stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. There are currently no neuroprotective treatments that minimise the brain damage that occurs immediately after a medical emergency of this kind and in the following hours.
Argenica Therapeutics, the biotechnology company commercialising ARG-007, has announced that the first volunteer to receive a dose showed no serious safety issues 24 hours after being injected.
This has opened the way for dosing of the remaining participants in cohort one.
Following the dosing of these volunteers, all follow up safety data will be presented to the Scientific Review Committee which will then confirm the progress of the trial to the next cohort.
The Phase 1 clinical trial, conducted at Linear Clinical Research facility in Perth, will assess ARG-007 across four cohorts of healthy adult volunteers, with each cohort receiving an ascending dose.
The trial is known as ‘doubleblind’, meaning that neither the participants nor the investigators know which volunteers receive a dose of ARG-007 and which receive a placebo.
“Commencing clinical trials is a significant milestone,” Professor Meloni said. “We have been working toward this goal for almost a decade and I’m incredibly proud of what we have achieved so far.”
Argenica’s Chief Executive Officer and Managing Director Dr Liz Dallimore said: “We are delighted our first clinical study of ARG-007 has commenced.
“This is a pivotal moment for Argenica, as we take groundbreaking research from the Perron Institute and UWA into the clinic.
“The aim is for the new therapeutic to be administered by first responders to protect brain tissue against damage during a stroke with further potential to enhance recovery once a stroke has occurred.”