Safety board backs continuation of TroVax Ph III

Oxford BioMedica, a UK gene therapy company, says that the independent data safety monitoring board for the Phase III TRIST study of its vaccine candidate TroVax in renal cancer has completed its second planned interim analysis. The DSMB concluded that the trial should continue as planned without modification. TroVax is Oxford BioMedica's novel cancer immunotherapy product, which is being developed in collaboration with Sanofi-Aventis.

TRIST is a Phase III evaluation of TroVax in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomized, placebo-controlled, two-arm study comparing TroVax in combination with standard-of-care to placebo with standard-of-care therapies which are interleukin-2, interferon-alpha or Sutent (sunitinib). The protocol stratifies treatment between the standard-of-care options to ensure that the allocation of TroVax and placebo is rigorously balanced.

The trial started in November 2006. To date, more than 500 patients have been randomized out of a target enrollment of around 700. Over 100 sites in the USA, European Union and Eastern Europe are recruiting patients. The primary endpoint for the trial is overall survival in the TroVax-treated group versus the placebo arm. Secondary endpoints include progression-free survival at 26 weeks, tumor response rates and quality-of-life scores.