Oxford BioMedica the leading gene therapy company, and its collaborators from the Institute of Ophthalmology in London, are today presenting encouraging preclinical data from the RetinoStat programme at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida, USA. The data show that two versions of the product are efficacious in an industry standard model of age-related macular degeneration (AMD), the leading cause of vision loss in the developed world.

Presentation at the 2005 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida

RetinoStat uses a LentiVector® system to deliver, to the retina, genes, which block the formation of new blood vessels that cause AMD. Oxford BioMedica is evaluating two versions of RetinoStat with the anti-angiogenesis genes, endostatin and angiostatin, respectively. The preclinical data being presented at ARVO assess the ability of RetinoStat to reduce the area of the eye with abnormal blood vessel growth (known as the area of choroidal neovascularisation or CNV) and to reduce blood vessel leakage in the eye, which leads to the distortion and loss of central vision in AMD.

Both versions of RetinoStat were safe and well tolerated and both achieved the two efficacy endpoints. The results show a statistically significant improvement in all scores. The area of CNV was reduced by 50-60% (p <0.05) and blood vessel leakage was reduced by 24-26% (p <0.05). The authors of the scientific abstract, from the Institute of Ophthalmology and Oxford BioMedica, conclude that similar improvements in these parameters in patients with AMD may translate into a significant and sustained improvement in visual acuity (a measure of clarity of vision).

In the second half of 2005, Oxford BioMedica expects to complete additional preclinical efficacy studies and optimisation of the RetinoStat configuration for clinical trials. The results from these studies will be published and presented at other relevant conferences in 2005-06. The Company's objective is to initiate clinical trials with RetinoStat in wet AMD in 2006-07.

Commenting on the data Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: “RetinoStat is meeting its design objectives and is on track for clinical development. AMD is a devastating disease and there is a real unmet need for a long-lasting efficacious product. RetinoStat is aimed at this large and growing market”.

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.

Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in early 2006, and four further preclinical candidates. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field.

The Company has a staff of approximately 65 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Amersham, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co and Biogen Idec.

2. RetinoStat and AMD

RetinoStat is Oxford BioMedica's novel gene-based treatment for wet age-related macular degeneration and diabetic retinopathy. The product uses a LentiVector system to deliver genes to the retina, which block the formation of new blood vessels that cause retinopathy. The company is evaluating two versions of RetinoStat with the anti-angiogenesis genes, endostatin and angiostatin, licensed from EntreMed of Rockville, Maryland, USA. These two biological products have been investigated extensively in various trials. The published data suggest that endostatin and angiostatin have very low toxicity, are well tolerated long term, and can shut down aberrant blood vessel growth.

Macular degeneration is a retinal degenerative disease that causes progressive loss of central vision. The risk of developing macular degeneration increases with age. Macular degeneration is the most common cause of vision loss in individuals over the age of 55. Wet age-related macular degeneration (AMD) accounts for about 10% of cases, but is responsible for 90% of severe vision loss.

There are 15 million people in the United States living with some form of AMD, with more than 1.6 million experiencing the active blood vessel growth and blood vessel leakage associated with wet AMD. There are over 200,000 new cases of wet AMD each year and this number is expected to increase significantly as the baby boomer generation ages and overall life expectancy increases. Presently, over 500,000 people worldwide lose their sight annually from the disease.

The preclinical studies with RetinoStat are being conducted with the company's collaborators at the Institute of Ophthalmology in London, UK, and at the Johns Hopkins Hospital in Baltimore, USA, with financial support from the US charity, Foundation Fighting Blindness.

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