Argenica (ASX:AGN) doses first 5 stroke patients with no adverse events

Argenica Therapeutics has widened its mid-stage stroke trial of its therapeutic to stave off brain cell death in ischaemic stroke patients with another two hospitals now online on Australia’s east coast in New South Wales and Queensland.

Five patients have now been dosed with ARG-007 and shown no related adverse events after presenting to the Royal Melbourne Hospital and the Princess Alexandra Hospital in Queensland and being diagnosed with acute ischaemic stoke caused by a large vessel occlusion.

John Hunter Hospital has also been activated to begin patient dosing in New South Wales and the Liverpool and Royal Adelaide hospitals are imminent, with the remainder of the 10-strong cohort set to come online over the next three months.

Argenica Managing Director Dr Liz Dallimore said the company was extremely appreciative of the hospitals’ commitment in actively managing, recruiting, and dosing patients.

“To achieve dosing of the first safety cohort after less than two weeks is a testament to the dedication of the clinical trial teams working in the emergency departments of our trial sites,” Dallimore said.

“We look forward to providing ongoing updates on the recruitment and DSMB outcomes as the trial progresses.”

The independent Data Safety Monitoring Board will now review the first five patients and make its recommendation on the study’s continuance under the current protocol.

The board is then scheduled for reviews at the 23, 46, and 69 patient marks, and at the trial’s conclusion after 92 doses.

After being proven safe and tolerable in healthy patients, the trial is designed to test safety in acute ischaemic stroke patients and generate preliminary data of its ability to reduce brain tissue death after stroke and removal of the clot.

Proof of ARG-007’s neuroprotective ability would significantly de-risk the treatment, a milestone which Argenica believes will offer the opportunity to be at the very forefront of neuroprotective clinical validation.

The trial is expected to run for about two years, and if successful, will open the path for wide-spanning third phase trials and greater engagement with global pharmaceutical companies.

Update: Argenica has entered a trading halt pending an announcement regarding a capital raising.

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