Oxford BioMedica gets US and French go-ahead to resume recruitment into ocular clinical trials

UK gene-based biopharma company Oxford BioMedica (LSE: OXB) has received agreement from the US Food and Drug Administration and the French regulatory agency, ANSM, to resume recruitment into the RetinoStat Phase I, StarGen Phase I/IIa and UshStat Phase I/IIa studies using the existing clinical trial material.

In June, the company voluntarily paused recruitment into the studies as a precautionary measure, while it investigated the detection of very low concentrations of a potential impurity in its clinical trial material derived from a third party raw material. It has since carried out studies to identify the impurity as highly fragmented DNA derived from fetal bovine serum (FBS), the most widely-used growth supplement for cell culture media. In light of these findings, Oxford BioMedica said it is convinced of the safety, integrity and quality of its LentiVectorplatform products and has no safety concerns relating to any of the ocular products have been identified in any pre-clinical and clinical data generated to date.

Regulators give it go-ahead