FDA Signs Off on Oxford's TroVax Trial Changes

摘要

The FDA has agreed to a number of proposed amendments to Oxford BioMedica's TRIST Phase HI clinical trial of TroVax vaccine therapy for renal cancer, the UK gene therapy company says. The changes include more interim analyses, which are scheduled to begin early next year, the company says in a statement. The analyses and an additional confirmatory trial may become part of a regulatory submission for the drug. Other amendments to the TRIST study focus on the number of doses, background standard of care and patients' prognostic factors. Oxford gave the FDA preliminary data from the study following an interim analysis by a data safety monitoring board in July. The board determined after its fourth interim review of the study that the vaccine would not meet its primary efficacy endpoint, Oxford said at the time.