OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO CONTINUE TROVAXÂ® PHASE III TRIST STUDY
ACHIEVEMENT TRIGGERS â‚¬10 MILLION MILESTONE PAYMENT FROM SANOFI-AVENTIS
Oxford, UK - 20 February 2008:Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its third planned interim analysis and recommended that the study continue without modification. TroVax is Oxford BioMedicaâ€™s novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. The continuation of the trial following this interim analysis triggers a milestone payment to Oxford BioMedica of â‚¬10 million.
The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues or efficacy issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis and provides no information beyond its recommendation.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. TRIST is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA) and was initiated in November 2006. To date, over 600 patients have been randomised and more than 100 sites in the USA, European Union and Eastern Europe are recruiting patients.
Professor Alan Kingsman, Chief Executive of Oxford BioMedica, said: "The DSMBâ€™s recommendation to continue the TRIST study is another important step in the Phase III development of TroVax, which is recognised in our collaboration with sanofi-aventis by a milestone payment. The trial is on track to complete patient enrolment before the end of this quarter and we anticipate final results in 2009. In addition to further progress of the TRIST study in renal cancer, future events will include sanofi-aventis commencing its planned Phase III trial of TroVax in patients with metastatic colorectal cancer."