Response to Press Comment on FDA Ruling

Oxford Biomedica PLC 24 January 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)171 606 1244 Scientific / Trade press Enquiries Sue Charles / Sarah Pattinson, HCC De Facto Tel: +44 (0)171 496 3300 RESPONSE TO PRESS COMMENTARY ON FDA RULING ON PHILADELPHIA GENE THERAPY TRIALS Following recent press coverage regarding the University of Pennsylvania's adenoviral gene therapy trial, the Directors of Oxford BioMedica would like to clarify that the Company does not have any clinical programmes that involve administration of adenoviral vectors to patients. Oxford BioMedica has developed a range of vectors to deliver therapeutic genes into patients' cells, which have been specifically selected for their safety and efficacy. Unlike some other gene therapy companies and academic research groups BioMedica has focused on developing gene transfer vectors from viruses that do not cause diseases in man, and which have been engineered so that there is no possibility of toxic viral proteins being made in the body. The most notable of these is BioMedica's proprietary LentiVectorTM system, which is based on the horse virus, equine infectious anaemia virus (EIAV), with which the Company has recently reported enhanced gene delivery to tumours in vivo. The Company currently has its cancer product, MetXia-P450, undergoing clinical trials and other products going through the pre-clinical regulatory process. In all cases the Company's procedures for clinical trials conform to the stringent criteria of the Gene Therapy Advisory Committee (GTAC) and the Medicines Control Agency (MCA) of the United Kingdom and they represent some of the most rigorous gene therapy research protocols worldwide. The trials are also managed by and report to an independent clinical trial organisation. Alan Kingsman, Chief Executive of Oxford BioMedica plc, said: 'One of the technical concerns over the use of adenoviral vectors has been that we all have adenovirus infections during our lives. As a result of these infections our immune systems are primed to react against this virus or gene delivery vectors derived from it. A strong immune reaction to a high dose of vector can trigger adverse effects in patients and this may have been what happened in the University of Pennsylvania case. It is, in part, for this reason that Oxford BioMedica does not use adenoviral vectors for direct administration to patients and has instead developed vectors from viruses that do not infect man. 'We see no reason why our product development programmes should be affected by these unfortunate events. The UK's overseeing body, the Gene Therapy Advisory Committee, is not making any changes to any trials and our trials are progressing on course. It is conceivable that some gene therapy companies in the USA, that use adenoviral vectors, may have trials delayed by the FDA while protocols are reviewed but that should not affect Oxford BioMedica's programmes.' Notes to Editors 1. Oxford BioMedica plc 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. Lentivirus vector systems In gene therapy, the aim is to deliver a gene and its necessary regulatory elements (the gene construct) to the cell surface, using a vector to mediate the transfer across the cell membrane and, in some cases, into the nucleus. A new and potentially very powerful vector system is based on lentiviruses, which have similar features to retroviruses in the ease of manipulation, predictable integration and reliable gene expression and regulation. In addition they show no detectable adverse inflammatory responses. However, their main advantage over retroviruses is the ability to function in non-dividing cells or cells that are dividing slowly - a feature of many clinically important tissues. 3. Adenoviruses Adenoviruses cause a common infection in man. Symptoms are usually those of a severe cold. 4. Worldwide web This release is also available on the Worldwide Web at http://www.oxfordbiomedica.co.uk
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