Posted: 29 May 2023
Patrys Limited, a therapeutic antibody development company, is pleased to announce that it has received favourable draft reports for two recently completed Good Laboratory Practice (GLP) toxicology studies testing PAT-DX1 in rats and a non-human primate species.
In these draft reports there were no safety or tolerability issues associated with PAT-DX1 in either species that are likely to impact on the ability to initiate human clinical studies with PAT-DX1. This is consistent with the favourable safety profile we have seen for PAT-DX1 in our non-GLP toxicology studies previously. Two additional draft reports that will provide further toxicological characterisation of the GLP PAT-DX1 antibody material are expected by the end of July. Patrys expects to receive the final reports, which will be used to support the application to initiate a clinical trial of PAT-DX1, towards the end of the year.
Patrys Chief Executive Officer and Managing Director, Dr. James Campbell said:
“We are very pleased to have completed these two toxicology studies in rats and a non-human primates and have them confirm the favourable safety profile that we have seen for PAT-DX1 to date. These studies are expected to complete the regulatory safety requirements that need to be fulfilled in order to start a clinical trial in cancer patients. While these are still draft reports, they typically would identify any major issues or areas of concern and so we do not expect the findings presented in the final report to differ materially. In the meantime, we believe that we will be able to restart manufacturing for the PAT-DX1 material for the clinical trial in Q3, CY2023.”
