Ethical Approval for Trovax

Oxford Biomedica PLC 16 October 2000 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: Sue Charles/Chris Gardner, HCC.De Facto Group Tel: +44 (0)20 7496 3300 OXFORD BIOMEDICA OBTAINS ETHICAL APPROVAL FOR TROVAX(TM) TO ENTER TRIALS FOR COLORECTAL CANCER. Oxford BioMedica announced today that it had received ethical approval from the UK Gene Therapy Advisory Committee ('GTAC') for its therapeutic cancer vaccine, TroVax(TM), to enter phase I/II clinical trials in patients suffering from colorectal cancer. The trials are planned to start at the end of the year. TroVax(TM) is designed to stimulate a patient's immune system to recognise and destroy cancer cells. 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 the tumour cells carrying TAA and destroy them. Commenting on GTAC's approval Chief Executive, Alan Kingsman said 'We are delighted with this decision by GTAC. This is the third BioMedica protocol that has been approved by the Committee and we are pleased to be establishing a good track record of approvable products. The preclinical data with TroVax(TM) are very promising suggesting that the product may be useful in a wide range of tumour types. We are fully aware that treating tumours in preclinical models is not the same as treating tumours in human beings. However we are optimistic about the future of this product.' Andrew Wood, BioMedica's finance director commented 'This is not only a major technical and commercial step for the Company, but it also represents a key development in our satisfying the London Stock Exchange's Chapter 20 rules for admission to the Official List, with respect to two products in clinical trials. We are on course to move up from the Alternative Investment Market early next year as long as market conditions are appropriate'. Notes to Editors 1. Oxford BioMedica Established in 1995, the Company specialises in the development and application of gene-based therapeutics using advanced gene delivery technologies for the treatment of disease in the areas of oncology, viral infection and neurodegenerative disease. Oxford BioMedica plc was floated on the UK Alternative Investment Market of the London Stock Exchange in December 1996. 2. Gene Therapy Advisory Committee The Gene Therapy Advisory Committee evaluates gene therapy trial protocols on the basis of the quality of the science, the details of the clinical protocol and ethical considerations. GTAC comprises technical experts and lay members. Following GTAC approval, clinical trial protocols and the products used by them are then reviewed by the Medicines Control Agency (MCA). On approval by the MCA, the products can be entered for clinical trials. This release is also available on the World Wide Web at: http://www.oxfordbiomedica.co.uk
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