Oxford Biomedica gets FDA SPA agreement for Ph III Trovax trial

UK-based Oxford BioMedica says that it has received a Special Protocol Assessment agreement from the US Food and Drug Administration for a Phase III trial of vaccine TroVax in renal cell carcinoma. This specifies the design, conduct, analysis and endpoints of the evaluation which, if successful, will support an efficacy claim in a regulatory submission for product registration. Oxford BioMedica plans to start the study in the second half of 2006.

The Phase III trial, referred to as TRIST (TroVax Renal Immunotherapy Survival Trial), will evaluate whether the vaccine, added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma. The study will be a randomized, placebo-controlled, two-arm study of TroVax in combination with standard of care versus placebo with standard of care. Standard of care will be interleukin-2, interferon-alpha or Sutent (sunitinib). Treatment will be stratified between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced. Recruitment will be around 700 patients in about 120 centers in the USA, European Union and eastern Europe. The primary endpoint will be survival improvement and secondary endpoints will include progression-free survival, tumor response rates and quality of life scores.