Argenica (ASX:AGN) doses first patient for pivotal human trial

Argenica Therapeutics has successfully dosed its first patient in pivotal phase 2 clinical trials, now officially underway to prove its ARG-007 drug’s efficacy in treating victims of acute ischaemic stroke.

The therapeutic’s safety and tolerability profile had been proven in a first phase of trials on healthy adults, and a patient with a confirmed diagnosis of stroke caused by a large vessel occlusion at the Royal Melbourne Hospital might be the first sufferer to ever be treated with ARG-007.

Given the trial is blinded, none of the trial or Argenica staff know whether ARG-007 or a placebo was used, but either way, the patient will now undergo a thrombectomy to reduce brain tissue death and mechanically remove the brain clot.

The trial will only enrol patients with that devastating LVO stroke to ensure improved control for endpoint evaluation and the clarity of a successful outcome.

Argenica Managing Director Dr Liz Dallimore said that with the first dosing, the company had now officially started its phase 2 clinical trial.

“We will be carefully monitoring the recruitment of patients in this trial, and report progress as we go,” Dr Dallimore said.

“We have engaged an amazing clinical trial team in hospital stroke units across Australia and are looking forward to continuing to work with them throughout the trial.”

Three out of ten trial hospitals are now activated, with another three set to join next month before the remainder activate after governance approval.

After they are treated, patients will be assessed for key safety, tissue death, and functional outcomes by the way of standard checks.

A patient safety review will be conducted after the first five patients are treated, with additional reviews at multiple points before the study’s end at 92 doses administered.

Clinical trials take time, particularly when stroke victims are unfortunately required, but ARG-007 has been long in the making since Western Australia-based researchers discovered that certain peptides could limit brain damage after a stroke.

With a dearth of treatments of its kind on the market, evidence of ARG-007’s ability to reduce the total volume of brain cell death by preserving neurons would position the therapeutic as a leading neuroprotective drug candidate.

Successful phase 2 trials would open the way for a wider-reaching phase 3 and potential partnerships with bigger players in biotech.

ARG-007 also has a wealth of preclinical data on its potential to treat other neurological impairments, but for now at least, the focus is on proving a winner in the battle against stroke.

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