OXFORD BIOMEDICA INITIATES TRIAL OF TROVAX IN RENAL CANCER

Oxford BioMedica has announced the start of TRIST, a pivotal, multicenter Phase III trial of TroVax, the company's cancer immunotherapy, in patients with advanced or metastatic renal cell carcinoma (RCC).

TRIST is designed to 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 carcinoma. The trial is a randomized, placebo-controlled, two-arm study that will compare TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies will be interleukin-2, interferon-alpha or Sutent (sunitinib).

Approximately 700 patients will be recruited from about 120 centers in the U.S., the European Union and Eastern Europe. The primary endpoint for the trial is survival improvement, and secondary endpoints include progression-free survival, tumor response rates and quality of life. The protocol includes the appointment of a safety and efficacy monitoring board to assess the safety and potential efficacy of the drug combinations at various time points during the trial.

Median survival for patients with advanced or metastatic RCC is approximately 11 months, according to the company. The duration of the trial will be determined by the number of survival events (deaths) in the study group. The trial is expected to reach a conclusion in 2008 to 2009, which would support the company's objective of reaching product registration in 2009.

In May the company and the FDA reached a special protocol assessment (SPA) agreement for the TRIST study. The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA.