AGM Statement

Oxford Biomedica PLC 15 April 2003 OXFORD BIOMEDICA PLC ('Oxford BioMedica'or 'the Company') COMPANY UPDATE AT AGM Oxford, UK: 15 April 2003. Oxford BioMedica is hosting its Annual General Meeting for shareholders today at 11.30am. The meeting will be held at the offices of Weil, Gotshal & Manges, 2nd floor, One South Place, London, EC2M 2WG. At the AGM, Oxford BioMedica will review its 2002 financial results and its product pipeline. In addition to the corporate update released with the preliminary results on 4th March 2003, the Company today announces the following information: TroVax(R) The expansion of the TroVax clinical programme, the Company's lead cancer immunotherapeutic, is proceeding according to plan. Regulatory approval from GTAC and MCA has been received to commence a Phase II trial in colorectal cancer patients. Initial data are anticipated later in 2003. In the US, the Company is planning a Phase I/II trial in renal cancer patients. A pre-IND meeting with the FDA is scheduled for May and the trial is expected to start in Q3 2003. MetXia(R) Preliminary data from the second Phase I/II study of MetXia in late stage breast cancer patients are encouraging. MetXia is Oxford BioMedica's lead gene-based cancer therapeutic. The initial results show that the higher potency version of MetXia substantially increases the efficiency of gene transfer to tumour tissue. This is exactly what the Company expected from its preclinical studies. Patient recruitment is ongoing and will shortly include patients from additional centres that will accelerate the trial. The Company intends to make a detailed announcement on the results of the study later in the year. ProSavin(R) Oxford BioMedica's lead neurobiology product, ProSavin, for treatment of Parkinson's disease is progressing in late preclinical studies. The Company is on-track to complete the first regulatory submission for the start of clinical trials by the end of 2003. The Company is securing cost efficient GMP manufacturing and identifying suitable clinical sites in readiness for initial human studies in 2004. Cash reserves extended The Company continues to restructure its research and development to focus on clinical and advanced preclinical products. As part of this process, Oxford BioMedica is reducing further its expenditure on early stage programmes, which includes neurobiology research in its San Diego facility, and other research activities in Oxford. In total the Company anticipates that its operating costs will be reduced by an annual £3.5 million, which extends the cash reserves until mid-2005 in a worst case scenario of there being no revenue from milestones on current collaborations or new deals in the meantime. This represents an extension of more than six months on previous estimates. The Company's cash position at 31st December 2002 was £21 million. The reduction in expenses anticipated by this restructuring will provide Oxford BioMedica with greater flexibility in its product development strategy and will not affect the progress of the lead programmes. The restructured San Diego operation will focus on the clinical development of ProSavin, interactions with the FDA and business development in the USA. Commenting on these new developments, Chief Executive, Professor Alan Kingsman said; 'TroVax and ProSavin are on course, and the initial MetXia results are encouraging. We are entering a very exciting phase in the Company's development with our major products reaching key stages. We must provide the resources to maximise their chances of success and to strengthen our negotiating position with potential partners. The restructuring of our research achieves those two goals' 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)20 7398 3300 Scientific/Trade Press Enquiries: Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7321 3870 Notes to Editors Oxford BioMedica Established in 1995 as a spin out from Oxford University, Oxford BioMedica plc specialises 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 development pipeline includes two novel anti-cancer products in clinical trials and a gene therapy treatment for Parkinson's disease, which is in late preclinical studies. This is underpinned by a broad research pipeline and over 70 patent families, about quarter of which are issued. Oxford BioMedica's products use genes as the mediators of a therapeutic effect and/or immune response. The Company's gene therapy products deliver therapeutic molecules in vivo whilst its gene-based immunotherapy products deliver genes that recruit the patient's immune system to mediate a therapeutic effect. The genes are delivered by the Company's highly engineered viruses or cells. BioMedica's lead product TroVax(R) is an anti-cancer therapeutic vaccine expected to be useful against a broad range of tumour types. It is entering Phase II trials in a number of indications including colorectal and renal cancer, and is expected to be ready for Phase III trials at the end of 2003. The Company's second cancer product, MetXia(R), is completing Phase I/II studies in breast cancer. Oxford BioMedica is headquartered in Oxford, UK and has a wholly-owned subsidiary in San Diego, USA. BioMedica has corporate collaborations with Wyeth, IDM, Intervet, Aliga Pharmaceuticals, Amersham, Arius Research and Viragen. Oxford BioMedica plc was floated on the Alternative Investment Market of the London Stock Exchange in December 1996, and was promoted to the United Kingdom Listing Authority Official List in April 2001 following a successful £35.5 million fund-raising. Further information is available on the World Wide Web at http://www.oxfordbiomedica.co.uk 2. Regulatory approval for clinical trials In the UK, gene therapy trial protocols are evaluated by the Gene Therapy Advisory Committee 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, a clinical trial exemption certificate (CTX) is issued and the products can be entered for clinical trials. In the USA there is a similar process culminating in the issue of an Investigative New Drug certificate (IND) by the Food and Drug Administration (FDA). This information is provided by RNS The company news service from the London Stock Exchange
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