Oxford BioMedica to resume recruitment for three clinical trials
Oxford BioMedica has received approval from the U.S. Food and Drug Administration and ANSM, the French regulatory agency, to resume recruitment for three studies using existing clinical trial material, according to a press release.
In June, Oxford BioMedica voluntarily stopped recruitment for the phase 1 RetinoStat, phase 1/2a StarGen and phase 1/2a UshStat phase studies as a precautionary measure while it investigated the detection of low concentrations of a potential impurity in its clinical trial material derived from a third-party raw material, the release said.
Oxford BioMedica has since identified the impurity as highly fragmented DNA derived from fetal bovine serum, the most widely used growth supplement for cell culture media. The company said it remains convinced of the safety, integrity and quality of its LentiVector platform products, and no safety concerns related to ocular products have been identified to date in preclinical and clinical data, the release said.
The company is working with clinical trial centers to obtain the necessary ethics committee approvals to resume recruitment into the studies.
Oxford BioMedica is developing gene-based treatments for several diseases, including neovascular age-related macular degeneration (RetinoStat), Stargardt disease (StarGen) and Usher syndrome type 1B (UshStat).