Oxford Biomedica Announces FDA Agreement on Revisions for Ongoing Trovax Phase III Trist Study

Oxford BioMedica announced today a successful meeting and agreement with the US Food and Drug Administration (FDA) regarding a series of amendments to the Phase III TRIST study of TroVax in renal cancer

Oxford, UK | October 07,  2008 | Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today a successful meeting and agreement with the US Food and Drug Administration (FDA) regarding a series of amendments to the Phase III TRIST study of TroVax in renal cancer. TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, which is being developed in collaboration with sanofi-aventis.

Oxford BioMedica requested and was granted a meeting with the FDA on 3 October 2008 to discuss the data collected to date from the TRIST study and proposed amendments to the study design, following the interim analysis by the Data Safety Monitoring Board (DSMB) in July 2008. The outcome of the meeting was that the FDA supported all aspects of the revised analytical plan for the study. The amendments are designed to explore whether patient outcome is dependent on the number of doses, background standard of care and patients' prognostic factors. The FDA agreed to review additional data from the TRIST study, which Oxford BioMedica is in the process of collecting from clinical sites. In addition, the FDA offered to continue its dialogue with Oxford BioMedica and sanofi-aventis to determine the path forward for further trials of TroVax in both renal and also colorectal cancer.

The revised protocol of the ongoing TRIST study includes additional interim analyses to be conducted at regular intervals. The first of these is scheduled for early 2009 and the results are expected to be reported at a relevant medical conference. Furthermore, the results of these additional analyses may form part of a regulatory submission alongside an additional confirmatory trial.

Pending further review of the TRIST interim data and FDA agreement, sanofi-aventis is committed to proceed with the planned TroVax Phase III colorectal programme. Oxford BioMedica and sanofi-aventis anticipate submitting additional data to FDA within the next few months. Further guidance on the timing and design of these trials will be provided in due course.

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. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk

TroVax®

TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, 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 antigen.

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 733 patients was completed at over 100 sites in the USA, European Union and Eastern Europe in March 2008. In July, the Data Safety Monitoring Board (DSMB) indicated that the trial would not reach its predefined primary efficacy endpoint of improved survival. The DSMB recommended that the trial continue but that further vaccinations discontinue.

SOURCE: Oxford BioMedica plc

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