FDA AGREEMENT ON TROVAX® PHAS
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For Immediate Release |
7 OCTOBER 2008 |
OXFORD BIOMEDICA ANNOUNCES FDA AGREEMENT ON REVISIONS FOR ONGOING TROVAX® PHASE III TRIST STUDY
Oxford, UK – 7 October 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.
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For further information, please contact: |
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Oxford BioMedica plc: John Dawson, Acting Chief Executive Officer Nick Woolf, Chief Business Officer |
Tel: +44 (0)1865 783 000 |
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JPMorgan Cazenove Limited: James Mitford/ Gina Gibson |
Tel: +44 (0)20 7588 2828 |
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City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications |
Tel: +44 (0)20 7466 5000 |
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Scientific/Trade Press Enquiries: Katja Stout/ Holly Griffiths/ John McIntyre College Hill Life Sciences |
Tel: +44 (0)20 7457 2020 |
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US Enquiries: Thomas Fechtner The Trout Group LLC |
Tel: (646) 378 2900 |
Notes to editors
1. Oxford BioMedica
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
2. 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.
3. 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.
This information is provided by RNS
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