Argenica Therapeutics’ (ASX: AGN) upcoming clinical trials for its lead stroke treatment drug ARG-007 are a step closer with the company completing final good laboratory practice (GLP) genotoxicity studies.
The studies have provided key data supporting the safety and tolerability of ARG-007 for the upcoming phase 1 clinical trial.
Argenica engaged Medicilon to carry out two in vitro genotoxicity studies on ARG-007.
According to Argenica, study data has shown ARG-007 “will not likely pose a genetic or carcinogenic risk” to patients. It also does not cause any structural damage to chromosomes in mammalian cells.
“The results of these GLP genotoxicity studies are important for inclusion in our ethics submission to commence our phase 1 clinical trial – clearly demonstrating that volunteers being administered ARG-007 will have no effect on their DNA or chromosomes or cause cancer in any manner,” Argenica chief executive officer Dr Liz Dallimore explained.
“Further, GLP genotoxicity studies are required for the US’ FDA regulatory approval for ARG-007, so it provides us with added confidence as we progress the clinical development of ARG-007.”
The genotoxicity data will be included in the ethics submission to secure approval for the trial. The studies are also investigational new drug enabling with the FDA – meaning the regulatory body will require the information for later stage clinical studies in the US.
Argenica’s next step before kicking-off clinical studies is to finalise dosing for the GLP pharmacokinetics (PK) and toxicology studies, which has begun.
Data from these pre-clinical activities is anticipated over the current quarter and early in the June quarter.
This information is also required for ethics approval for the phase 1 trial in healthy human volunteers.
To expedite ethics approval, Argenica has already completed a draft submission which will be reviewed by Bellberry, which is the organisation that will provide final approval through its Human Research Ethics Committees.
After reviewing the draft submission, Bellberry will provide feedback. Once all required data is at hand, Argenica will be in a position to immediately lodge its final ethics application, which it expects to do next quarter.