FDA approves amendments to Oxford BioMedica TroVax study

Source: Healthcare Digital

Date :07/10/2008 08:58:36

Oxford BioMedica plc said today, October 7, that the US Food and Drug Administration (FDA) had approved a series of amendments to the PHASE III TRIST study of its lead drug TroVax in renal cancer.

The drug is being developed in collaboration with French drugmaker Sanofi-Aventis.

Oxford BioMedica said that the amendments are designed to explore whether patient outcome is dependent on the number of doses, background standard of care and patients' prognostic factors.

The revised protocol of the ongoing TRIST study includes additional interim analyses to be conducted at regular intervals.

John Dawson, Acting Chief Executive of Oxford BioMedica, said that the firm was “encouraged by the FDA's feedback and guidance”.

“The agreed amendments to the TRIST study should enable us to identify the optimal setting and regimen for TroVax in renal cancer and we remain optimistic that TroVax may show benefit in a subset of patients,” he said.