Oxford BioMedica, a leading gene therapy company in the United Kingdom, has announced an agreement with the FDA concerning a series of amendments to its phase 3 study of TroVax, a novel therapeutic vaccine for renal cancer.
The vaccine is being developed in collaboration with Sanofi-Aventis. The amendments to the TroVax Renal Immunotherapy Survival Trial (TRIST) are designed to determine whether outcome is dependent on the number of doses, background standard of care, or patients’ prognostic factors.
The FDA agreed to review additional data from TRIST, which Oxford BioMedica is collecting from clinical sites.
n addition, the agency offered to continue its dialogue with Oxford BioMedica and Sanofi-Aventis to commence further trials of TroVax for colorectal cancer. Both companies anticipate submitting additional data to FDA within the next few months.