- Argenica Therapeutics (AGN) completes safety pharmacology preclinical studies with no abnormal symptoms observed
- Through its preclinical contract research organisation, the company undertook three safety studies, conducted under the good laboratory practice regulatory framework
- Rats received doses of Argenica’s treatment to reduce brain tissue death, at both the efficacious dose and maximum tolerated dose
- Combined with the recent GLP toxicology studies, the company says these safety studies provided added confidence for its upcoming Phase 1 clinical trial
- Argenica Therapeutics was up 11.4 per cent, trading at 49 cents at 1:25 pm AEST
Argenica Therapeutics (AGN) has completed its safety pharmacology preclinical studies, with no abnormal symptoms observed.
The company has been working to develop novel therapeutics to reduce brain tissue death after stroke and improve patient outcomes.
Argenica’s treatment, ARG-007, has proven to improve outcomes in pre-clinical stroke models, and is in the process of being verified for safety and toxicity before beginning phase one clinical trials in humans.
Through its preclinical contract research organisation, the company undertook three safety studies, conducted under the good laboratory practice (GLP) regulatory framework.
These were rat behaviour safety pharmacology, rat respiratory safety pharmacology and non-human primate cardiovascular safety pharmacology studies.
The animals received doses of ARG-007 at the efficacious dose and up to the maximum tolerated dose.
The company said these studies are a key requirement for its ethics submission for an upcoming phase one clinical trial.
Safety pharmacology studies investigate the potential undesirable pharmacodynamic effects of a drug substance on physiological functions, identifying any adverse effects of a substance on the major physiological systems.
Combined with the recent GLP toxicology studies, these safety studies provide the company with added confidence for the upcoming Phase 1 clinical trial.
“We are extremely encouraged by the results of these GLP safety pharmacology studies, which show that even at high doses of ARG-007, there were no abnormal effects seen,” Chief Executive Officer, Dr Liz Dallimore, said.
Argenica’s package of required preclinical safety study assessments required for ethics approval have now largely been completed, except for a final pathology assessment of the toxicology and the pharmacokinetic (PK) study.
Argenica Therapeutics was up 11.4 per cent, trading at 49 cents at 1:25 pm AEST.