Argenica Therapeutics completes key safety studies for IND application

Argenica Therapeutics Limited (ASX:AGN) has successfully completed key safety studies required for the inclusion of ARG-007 in the Company's Investigational New Drug (IND) Application. The positive results in these studies confirm the competitive position of ARG-007 and its unique mechanism of action, paving the way for later stage clinical trials in acute ischaemic stroke (AIS) patients in the US.

Executive Commentary

Dr Liz Dallimore, Managing Director of Argenica, stated, 'The results generated from these studies not only supports our IND application to the FDA, but also provide further confirmation that ARG-007 has a unique mechanism of action and pharmacological profile which lends itself to being an ideal therapy in acute ischaemic stroke. We are working with our FDA regulatory consultants to compile the documentation required for our IND application, and with the completion of these studies, the Company is now well positioned to submit the IND application to the FDA by the end of this calendar year.'

Summary

Argenica Therapeutics (ASX:AGN) has successfully completed key safety studies required for the inclusion of ARG-007 in the Company's Investigational New Drug (IND) Application. The positive results confirm the competitive position of ARG-007 and its unique mechanism of action, demonstrating its potential as an ideal therapy in acute ischaemic stroke. The completion of these studies positions the Company well to submit the IND application to the FDA by the end of the calendar year, enabling later stage clinical trials in the US. Argenica is fully funded to complete the Phase 2 clinical trial, which is progressing well with no safety issues identified to date.