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2008/OB/22
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OXFORD BIOMEDICA RECEIVES COMMITMENT FOR INDEPENDENT PHASE III TRIAL OF TROVAX® IN ADJUVANT COLORECTAL CANCER
Oxford, UK - 14 July
2008: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that the Oncology Clinical Trials Office (OCTO) remains committed to progress its Phase III trial of TroVax in adjuvant colorectal cancer. The proposed trial, called QUASAR V, is being coordinated by OCTO, which is part of the Clinical Pharmacology Department of Oxford University. TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, which is being developed in collaboration with sanofi-aventis.
OCTO issued its statement regarding the use of TroVax in the QUASAR V trial following the recommendations of the Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer, which was announced on 11 July. The statement was signed by Professor David Kerr, Director of OCTO, and Dr Rachel Midgley, Clinical Director of OCTO. The statement is as follows:
"Our understanding of the Data Safety Monitoring Board's recommendations issued in relation to the TRIST study in renal cancer does not impact on our enthusiasm to progress the QUASAR V TroVax study in adjuvant colorectal cancer. From both a scientific and clinical perspective we feel that TroVax should be tested in the adjuvant setting of colorectal cancer and remain committed to the study." http://octo-oxford.org.uk/TroVax
QUASAR, which stands for QUick And Simple And Reliable, is a collaborative clinical trials group focused on colorectal cancer. The proposed QUASAR V study is a randomised, placebo-controlled Phase III trial of TroVax in patients with Stage II/III colorectal cancer who have had surgical resection of their primary tumours and been treated with adjuvant chemotherapy. It is expected to enrol approximately 3,000 patients and has been designed with a primary endpoint of three-year disease-free survival. The funding of QUASAR trials derives from a variety of sources, including the UK Medical Research Council and the Department of Health.
Oxford BioMedica and its partner, sanofi-aventis, are reviewing the development plan for TroVax, including the QUASAR V study and the proposed Phase III trial in metastatic colorectal cancer.
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1. |
Oxford
BioMedica plc |
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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. TroVax® is the Company's therapeutic vaccine, which is in clinical development for multiple solid cancers. The product is licensed to sanofi-aventis for global development and commercialisation. 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.
Further information is
available at
www.oxfordbiomedica.co.uk |
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2. |
TroVax® |
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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.
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3. |
Oncology Clinical Trials Office |
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The Oncology Clinical Trials Office (OCTO) is concerned with the practical application of high-quality clinical research into innovative and effective cancer therapies particularly in the field of gastrointestinal cancer. OCTO's key aims are to improve both survival rates and the quality of life of cancer patients by contributing to the evidence-base that will underpin cancer services now and in the future; and to bring about major and continuing improvements in the quality of practice in clinical research. These aims will be achieved in partnership with academic-led research communities, with industry and with patients and their carers. OCTO is part of the Clinical Pharmacology Department of Oxford University. Further information is available at http://octo-oxford.org.uk/TroVax
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Oxford BioMedica plc
Mike McDonald, Chief Executive Officer
Nick Woolf, Chief Business Officer
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