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June 3, 2013 - Oxford BioMedica, a leading gene therapy development company in the United Kingdom, announced today that it has voluntarily paused participant recruitment for its retinal gene therapy clinical trials due to the detection of very low concentrations of potential impurities in material used to make the treatments. The clinical trials impacted by this action are for RetinoStat®, StarGen™ and UshStat®, potential therapies for wet age-related macular degeneration, Stargardt disease and Usher syndrome type 1b respectively.
Such actions are performed routinely in human studies to ensure safety and quality of emerging therapies.
At this point, no safety concerns have been identified for any study participants. No adverse events have been reported.
Oxford is conducting additional, more sensitive testing as a precautionary measure, and working closely with regulatory authorities to further investigate its findings.
The Foundation will provide additional information on the status of Oxford BioMedica’s gene therapy clinical trials as soon as it becomes available.
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