Patrys Ltd (ASX:PAB) welcomes promising draft reports from two recently completed Good Laboratory Practice (GLP) toxicology studies on its lead PAT-DX1 product, a significant milestone in preparation for a phase one clinical trial towards the end of the year.
These studies, conducted on rats and a non-human primate species, reported no safety or tolerability issues that are likely to hinder human clinical studies.
PAT-DX1 is designed to treat cancer and has previously demonstrated its ability to kill cancer cells in cell-based experimental systems, human tumour explants, xenograft and orthotopic models.
Investors have also welcomed the reports, sending shares 30% higher in early ASX trading to $0.013 with more than 3 million shares changing hands in just 15 minutes.
Safe and well-tolerated
The positive toxicology results align with previous non-GLP studies on PAT-DX1, further solidifying its favourable safety profile.
Two additional draft reports detailing further toxicological characterisation of the GLP PAT-DX1 antibody material are expected by the end of July.
Meeting regulatory requirements
“We are very pleased to have completed these two toxicology studies in rats and non-human primates and have them confirm the favourable safety profile that we have seen for PAT-DX1 to date,” Patrys chief executive officer and managing director James Campbell said.
“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.”