TroVax into Clinical Trials

Oxford Biomedica PLC 2 January 2001 For further information, please contact: Oxford BioMedica plc Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: David Simonson/Melanie Toyne Sewell Merlin Financial Communications Tel: +44 (0)20 7606 1244 Scientific/Trade Press Enquiries: Chris Gardner, HCC.De Facto Group Tel: +44 (0)20 7496 3300 OXFORD BIOMEDICA COMMENCES CLINICAL TRIAL OF TROVAX(TM) Oxford, UK - 2 January 2001: Oxford BioMedica ('BioMedica') announced today that the Medicines Control Agency (the 'MCA'), the division of the National Health Service which regulates the safety, quality and efficacy of all medicines in the UK market, has approved BioMedica's cancer vaccine, TroVax(TM) for a Phase I/II clinical trial in patients with colorectal cancer. TroVax(TM) is a gene-based therapeutic vaccine that is designed to stimulate the patient's immune system to mount a powerful anti-cancer response. The immune system plays a key role in fighting infections and disease. However with cancer, the patient's immune system often fails to react to the existence of a tumour and as a result an immune response is not triggered. TroVax(TM) is designed to stimulate a patient's immune system to recognise and destroy cancer cells in this situation. The product is based on a gene that encodes a protein that exists only on the surface of tumour cells and not on normal cells - such proteins are known as Tumour Associated Antigens (TAAs). When this gene is expressed by Oxford BioMedica's highly engineered virus-based delivery system, it induces a potent anti-tumour response. This means that cells and antibodies of the immune system seek out tumour cells carrying the TAA and destroy them. In preclinical model systems the results have been very striking, with TroVax(TM) breaking immune tolerance to tumours and protecting against further tumour growth. TroVax(TM) will be trialled on patients with late stage colorectal cancer, at the Christie Hospital, Manchester, one of the UK's leading cancer centres. BioMedica is already in Phase I/II clinical trials with MetXia(R), its first anti-cancer gene therapy product. During 2000, the Company also completed two collaborative agreements based on TroVax(TM) and its related technology. In the first collaboration, a veterinary version of TroVax(TM) was licensed to the major European veterinary company, Virbac SA for development to treat cancer in 'companion' animals e.g. dogs. The second agreement was with Nycomed Amersham to develop a tumour imaging agent based on a proprietary antibody to the TAA targeted by TroVax(TM). Commenting on the announcement, Professor Alan Kingsman, Chief Executive of Oxford BioMedica, said: 'This is a very significant development. Already TroVax(TM) and its related technology have attracted substantial commercial interest and are the subject of two important collaborations. While we recognise that our successes to date have been in model systems for cancer, the strength of our preclinical results together with the potentially broad applicability of TroVax(TM) to treat a wide range of cancers, make this a leading product in BioMedica's portfolio, either for use on its own as a cancer vaccine or in conjunction with other treatments.' Notes to Editors 1. Oxford BioMedica plc Established in 1995, the Company specialises in the development and application of gene-based therapeutics and immunotherapeutics for the treatment of disease in the areas of Oncology, Neurobiology and Viral Infection and in Gene Discovery. Oxford BioMedica plc was floated on the Alternative Investment Market of the London Stock Exchange in December 1996. Currently Oxford BioMedica has corporate collaborations with Aventis, AstraZeneca, IDM, Modex Therapeutics, Nycomed Amersham, Valentis and Virbac. BioMedica's first clinical product, MetXia(R) is in Phase I/II clinical trials for late-stage breast cancer (BC1) and ovarian cancer (OC1). TroVax(TM) is the Company's second product in clinical trials. 2. World Wide Web This release is also available on the World Wide Web at http://www.oxfordbiomedica.co.uk
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