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Oxford BioMedica announced today that it has successfully completed patient enrolment in the Phase III TRIST study of TroVax in renal cancer
OXFORD, UK | March 10, 2008 | Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that it has successfully completed patient enrolment in the Phase III TRIST study of TroVax in renal cancer. TroVax is Oxford BioMedica’s novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. Over 690 patients have been randomised to-date and a sufficient number of additional patients are being screened for inclusion such that the total enrolment is expected to slightly exceed the target of 700 patients. Over 100 sites in the USA, European Union and Eastern Europe have recruited patients into the trial. The trial started in November 2006, recruitment has been completed on schedule and final results from the study are anticipated in the first half of 2009.
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. It is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). Oxford BioMedica recently announced that the independent Data Safety Monitoring Board (DSMB) for the TRIST study completed its third planned interim analysis and recommended that the study continue without modification.
Dr Mike McDonald, Chief Medical Officer of Oxford BioMedica, said: "Completing recruitment so rapidly in such a large Phase III trial is a significant achievement for us. We are extremely grateful to the clinicians for their support and, of course, the patients with renal cancer that are participating in the TRIST study. The trial is on track to reach its final analysis in the first half of 2009. We, together with our partner sanofi-aventis believe that TroVax could provide an important treatment option for patients with renal cancer as well as potentially other common types of cancer. We are delighted that, within the next few months, sanofi-aventis will broaden the development programme for TroVax with the start of the first Phase III trial of TroVax in colorectal cancer."
Oxford BioMedica plc
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in cancer immunotherapy and gene-based therapies. The Company was established in 1995, as a spin-out from Oxford University, and is listed on the London Stock Exchange.
The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. The lead product candidate is TroVax®, an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. TroVax is in Phase III development. Oxford BioMedica has three other products in clinical development, including ProSavin®, a novel gene-based treatment for Parkinson’s disease, in a Phase I/II trial. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 85. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer.
TroVax®
TroVax is Oxford BioMedica’s novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a Modified Vaccinia Ankara vector, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4.
Phase III TRIST study
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. Recruitment of approximately 700 patients is complete at over 100 sites in the USA, European Union and Eastern Europe. TRIST is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA).
SOURCE: Oxford BioMedica plc |
