- Argenica Therapeutics (AGN) completes its preliminary pre-clinical toxicology studies of ARG-007 in rat and non-human primates, and preliminary in vitro genotoxicity studies
- The company has now identified a maximum safe starting dose for humans and that the drug does not appear to mutate DNA
- AGN will confirm the studies with a good laboratory conditions (GLP) study before it can apply for regulatory approval
- Further, the company has begun final GLP studies to confirm the safety and tolerability of single doses of ARG-007 prior to the start of the phase one clinical trial
- Shares are trading 10.5 per cent down at 77 cents each at market close
Argenica Therapeutics (AGN) has completed its preliminary pre-clinical toxicology studies of ARG-007 in rat and non-human primates, and preliminary in vitro genotoxicity studies.
ARG-007 aims to reduce brain tissue death after a stroke, traumatic brain injury or hypoxic ischaemic encephalopathy (an event when not enough oxygen or blood goes to the brain).
Toxicology studies are used to determine adverse effects that may occur at specified dosing levels. Through the most recent study, the company has determined a maximum safe starting dose for humans.
Genotoxicity studies determine the ability of substances to damage DNA or chromosomes within cells. At this stage, the company advises that ARG-007 does not appear to mutate the DNA.
The studies were completed under non-good laboratory practice (non-GLP) conditions and in order to receive regulatory approval, AGN will need to complete studies under good laboratory practice (GLP).
The company said the non-GLP studies have enabled it to identify suitable dose ranges at a lower cost so it can progress to GLP studies with more confidence.
The non-GLP data may also be submitted in its ethics submission for the phase one clinical trial.
Argenica has now begun final GLP studies to confirm the safety and tolerability of single doses of ARG-007 prior to the start of the phase one clinical trial.
The GLP genotoxicity studies are near completion and the company expects to report the results during this quarter.
“The results of these non-GLP studies have provided us with great confidence as we finalise our GLP preclinical studies,” CEO Liz Dallimore said.
“Identifying the dose ranges for our critical toxicity studies and estimating ARG-007’s no observed adverse effect level, which is important above our efficacious dose, is a vital step in achieving Human Research Ethics Committee approval and commencing our Phase 1 clinical trial.”
Shares were trading 10.5 per cent down at 77 cents each at market close.