Ark will work with PsiOxus in providing oncolytic adenoviral material for IV administration in toxicological and Phase I/II clinical studies, using Ark’s suspension based single use system (ATOSUS).
Ark CEO Martyn Williams said PsiOxus will benefit from Ark’s experience in the regulatory CMC aspects of developing a gene-based medicine.
PsiOxus CEO John Beadle said, of critical importance to them was to choose a manufacturing partner who had not only the relevant manufacturing know-how but also the manufacturing development capability and specific regulatory knowledge to ensure they hit development timelines through the timely provision of material for final pre-clinical toxicology and clinical phases.