Data on RetinoStat

Oxford Biomedica PLC 06 May 2003 OXFORD BIOMEDICA AND THE INSTITUTE OF OPHTHALMOLOGY PRESENT PRECLINICAL RESULTS FROM THE RETINOSTATTM PROGRAMME FOR VISION-LOSS Oxford, UK: 6 May 2003. Oxford BioMedica and The Institute of Ophthalmology are describing two key features of the Company's vision-loss product RetinoStat(TM) at The Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), held in Fort Lauderdale, Florida, during May 4th-8th. This is the world's biggest forum for eye research and is attended by all principal commercial and scientific players in the field, a total of around 8,000 attendees. In two separate presentations the Company and the Institute's Ocular Gene Therapy Group, led by Dr. Robin Ali, are showing data that confirm RetinoStat's ability to target accurately the retina using the Company's LentiVector(R) system. In addition, the Company's Hypoxia Response Element technology is shown to focus gene expression in those parts of the retina that are local to the pathological changes associated with age-related macular degeneration (AMD) and diabetic retinopathy (DR), the two major causes of vision-loss in the developed world. These data were generated in industry-standard preclinical models for the two diseases, and demonstrate proof-of-principle for delivery to the retina and regulation of the gene. These are essential features required for a safe and effective product. Hence, the encouraging preclinical results mean that the RetinoStat programme is on track for clinical development in 2004. Age-related macular degeneration ('AMD') and diabetic retinopathy ('DR') affect approximately 30 million people in the developed world and the market potential is in excess of $1.0 billion. In both AMD and DR, blindness is caused by the defective formation of new blood vessels in the retina. In AMD, new blood vessels extend from the inner retina beyond the inner limiting membrane, which leads to haemorrhaging and distortion of the specific area of the retinal surface responsible for sharp, central vision. In DR, a similar process occurs however, the new blood vessels appear on the vitreous surface of the retina causing excessive accumulation of fluid or 'oedema', which blurs vision and causes retinal haemorrhage. RetinoStat is designed to halt this aberrant growth of blood vessels before it begins. Currently, the only available treatments for AMD and DR are limited and tend to only slow the diseases' progression. The collaboration between Oxford BioMedica and the Institute of Ophthalmology was initiated in May 2002. It is a research and development agreement using the Company's proprietary technology to develop novel treatments for vision loss. RetinoStat comprises a LentiVector gene delivery system expressing an angiostatic gene under the control of Oxford BioMedica's Hypoxia Response Element, which promotes gene expression under low oxygen conditions. Commenting on the results Chief Executive, Professor Alan Kingsman said, 'We are delighted to be presenting at the major vision conference of the year. Our RetinoStat data are exciting and this forum allows us to describe the results to the widest possible audience including potential commercial partners. This is the first public statement of progress from the collaboration and we look forward to more developments in the coming months'. Dr Robin Ali, Head of the Ocular Gene Therapy Group at the Institute of Ophthalmology said, 'We are very pleased to be working with Oxford Biomedica. Our recent results support the use of their LentiVector and Hypoxia Response Element technologies for the treatment of ocular disorders and pave the way for advancement to clinical trials'. Background to age-related macular degeneration ('AMD') and diabetic retinopathy ('DR') AMD is now one of the major debilitating diseases of the ageing population. About one in six people between the ages of 55 and 64 will develop AMD while one in four between 64 and 74 will be affected. One in three over the age of 75 will be affected. Each year 1.2 million of the estimated 12 million Americans with macular degeneration will suffer severe central vision loss. Each year 200,000 individuals will lose all central vision in one or both eyes due to AMD. DR is the commonest cause of visual loss in people of working age and the predominant cause of economic loss due to visual impairment. Over 40% of people with insulin dependant and 20% of people with non-insulin dependent diabetes eventually succumb to diabetic retinopathy. In the US alone, where an estimated 16 million people have either type I or II diabetes, about 600,000 have retinopathy. Direct and indirect costs of diabetic retinopathy totalled more than $ 2.8 billion in 1996. 2% of insulin dependent diabetics are totally blind, many of them in the younger age group. -Ends- 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 1. 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. The Institute of Ophthalmology The Institute of Ophthalmology has the strongest multidisciplinary scientific resource of any such eye centre in the world. The Institute's world leading programme of research into the mechanisms and treatment of eye disease draws on the tremendous clinical resource of Moorfields Eye Hospital and with this provides an unparalleled focus for the rapid development of new treatments. The Institute of Ophthalmology was recently awarded UK government funding under the Wellcome Trust sponsored JIF mechanism to create a centre for the identification and development of novel treatment strategies for ocular disease This information is provided by RNS The company news service from the London Stock Exchange
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