The US FDA grants a Special Protocol Assessment (SPA) to Oxford BioMedica, for phase III trial of TroVax in renal cell carcinoma. The written agreement from the FDA specifies the design, conduct, analysis and endpoints of the trial, which, if successful, will support an efficacy claim in a regulatory submission for product registration. The SPA was received at the end of the FDA's first review period following Oxford BioMedica's application in March 2006. Oxford BioMedica plans to start the trial in the second half of 2006.

The phase III trial, referred to as TRIST (TroVax Renal Immunotherapy Survival Trial), will evaluate whether TroVax immunotherapy, added to first line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma. Standard of care will be interleukin-2, interferon-alpha or Sutent (sunitinib). Study treatment will be stratified between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced. The protocol includes the appointment of a Safety and Efficacy Monitoring Board (SEMB) to assess the safety and potential efficacy of the drug combinations at various time points during the trial.

Oxford BioMedica is also discussing the TRIST trial with regulatory authorities in Europe. In addition, the company plans to seek 'orphan drug' designation for TroVax in both the USA and Europe for renal cell carcinoma.

Oxford BioMedica's chief medical officer, Dr Mike McDonald said, "We are delighted to have secured the SPA within such a short time period. We have worked closely with the FDA on the design of the TRIST study and they have been extremely supportive. We look forward to starting this pivotal trial of TroVax in a cancer setting where there are few treatment options and there is a need for new approaches that are both safe and effective."