FDA supports revised analysis plan for TRIST study

UK gene therapy company Oxford BioMedica says that the US Food and Drug Administration supported all aspects of its revised analytical plan for the TRIST study. The amendments are designed to explore whether patient outcome is dependent on the number of doses, background standard of care and patients' prognostic factors.

Earlier this year (Marketletter July 21), the firm discontinued the Phase III evaluation of its TroVax vaccine in renal cancer, as the trial's independent data safety monitoring board warned it would not meet its primary efficacy endpoint.

The revised protocol of the ongoing TRIST study includes additional interim analyses to be conducted at regular intervals. The first of these is scheduled for early next year and the results are expected to be reported at a relevant medical conference. Furthermore, the results of these additional analyses may form part of a regulatory submission alongside an additional confirmatory trial, Oxford BioMedica noted.