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Oxford Biomedica PLC 28 August 2003 28 August 2003 For further information, please contact: Oxford BioMedica plc Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: Mike Wort, James Chandler: Beattie Financial Tel: +44 (0) 7730 418 745 Scientific/Trade Press Enquiries: Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150 CANCER RESEARCH UK SUPPORTS ADDITIONAL TROVAX PHASE II TRIAL IN COLORECTAL CANCER Oxford, UK: 28 August 2003 - Oxford BioMedica announced today that Cancer Research UK has agreed to conduct and sponsor an open label Phase II trial with Oxford BioMedica's leading cancer immunotherapy product, TroVax(R), in colorectal cancer patients who have liver metastases. The decision by Cancer Research UK follows extensive review of the successful Phase I/II data of TroVax in colorectal cancer patients. This study is in addition to the two ongoing Phase II trials with TroVax in colorectal cancer alongside chemotherapy, and the planned trials in renal and breast cancer. The patient population in the Cancer Research UK Phase II trial will comprise twenty Stage IV colorectal cancer patients who are to undergo surgery for resectable liver metastases. Patients will receive injections of TroVax followed by surgery approximately two weeks later. Biopsies of the tumour will be taken at surgery and analysed for TroVax stimulated immune activity. Further vaccinations will be given after surgery. Patients' management will then continue as standard, usually including adjuvant chemotherapy. Patients will be followed after the final vaccination to assess immune responses and toxicity and then monitored over the longer term for clinical benefit. Commenting on the announcement, Oxford BioMedica's chief executive, Professor Alan Kingsman said, 'Cancer Research UK is one of the world's leading cancer research organisations and is committed to the development of better cancer treatments for patients. Their involvement in this project provides further validation of Oxford BioMedica's advanced cancer immunotherapeutic' Ends- Notes to editors 1. Oxford BioMedica Based in Oxford, UK, Oxford BioMedica is a biopharmaceutical company specialising in the development of novel gene-based therapeutics for the treatment of cancer, neuro-degenerative disease and other disorders with major unmet clinical needs. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange. In addition to its technical research skill-base, Oxford BioMedica has in-house clinical, regulatory and manufacturing know-how. The development pipeline includes two novel anti-cancer products in clinical trials and a gene-based treatment for Parkinson's disease, which is in late preclinical studies. The Company is underpinned by an extensive preclinical and research portfolio and over 70 patent families, about quarter of which are issued. TroVax(R), which is Oxford BioMedica's lead cancer immunotherapy product, is in Phase II trials for colorectal cancer (see below). MetXia(R) is Oxford BioMedica's lead gene-based cancer therapeutic. The product is based on a highly engineered retrovirus gene delivery system expressing a specific human cytochrome P450 gene. MetXia converts the tumour into a 'drug factory', enabling increased local production of the anti-tumour, cytotoxic derivative of the pro-drug cyclophosphamide. MetXia is potentially useful in the treatment of all solid tumours and their metastases, particularly those where cyclophosphamide is commonly used. MetXia is being investigated in a Phase I/II trial in breast cancer, and regulatory submissions are under review for trials in pancreactic cancer. Oxford BioMedica has a wholly-owned subsidiary in San Diego, USA. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Aliga Pharmaceuticals, Amersham, Arius Research and Viragen. Further information is available at http://www.oxfordbiomedica.co.uk 2. TroVax TroVax is Oxford BioMedica's leading cancer immunotherapy product. 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 poxvirus (MVA) gene transfer system, 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 protein. Two Phase I/II trials with TroVax have been completed in the UK in late-stage colorectal cancer patients. Following these successful Phase I/II trials, TroVax has entered two Phase II trials in Stage IV colorectal cancer patients receiving 5FU plus either oxaliplatin or irinotecan. The product is also on target to enter further trials in colorectal, renal and breast cancer. The renal and breast cancer trials are to be conducted in the United States under an Investigational New Drug (IND) application. Data from the first TroVax Phase II trial is expected to be available by the end of 2003, in readiness for Phase III trials in colorectal cancer. 3. Cancer Research UK Cancer Research UK began operating on 4 February 2002 as a result of the merger between The Cancer Research Campaign and Imperial Cancer Research Fund. Its vision is to conquer cancer through world-class research. It is the largest volunteer-supported cancer research organisation in the world with a dedicated team of 3,000 scientists and an annual scientific spend of more than £176 million. Its objectives, amongst others, are to: carry out world class research into cancer; develop better treatments for cancer patients; improve the quality of life of cancer patients; reduce the number of people getting cancer; improve training and support of cancer research workers; and provide authoritative information and advocacy on cancer. This information is provided by RNS The company news service from the London Stock Exchange
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