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Oxford Biomedica Reports Encouraging Preclinical Data With Retinostat (R) In Retinopathy And Demonstrates The Potential Of Lentivector (R) In Other Ocular Diseases

02 May 2006

Data presented at Association for Research in Vision and Ophthalmology meeting View Abstracts

OXFORD, UK | May 02, 2006 | Oxford BioMedica (LSE: OXB), the leading gene therapy company, and its collaborators at Johns

Hopkins University School of Medicine, Baltimore, Maryland, USA, are presenting three posters at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which is being held from 30 April to 4 May 2006 in Fort Lauderdale, Florida, USA. These posters describe positive preclinical results of RetinoStat in wet age-related macular degeneration and the potential application of the LentiVector system in corneal endothelial disorders.

RetinoStat is a gene-based medicine based on Oxford BioMedica’s proprietary LentiVector system, delivering two anti-angiogenic genes that halt the aberrant growth of blood vessels that leads to vision loss in wet age-related macular degeneration (AMD), a leading cause of adult blindness in developed countries. The preclinical data presented at ARVO confirm that RetinoStat provides statistically significant efficacy in an industry-standard in vivo model of wet AMD. In addition, by precisely engineering gene switches in the product, the Company has achieved highly specific gene expression in the target cells of the retina. This substantially enhances the potential safety and efficacy of RetinoStat. The new data also confirm that the optimised configuration of RetinoStat, with two anti-angiogenic genes (endostatin and angiostatin), has efficacy superior to configurations based on single genes

Oxford BioMedica’s collaborators at Johns Hopkins University also showed data from an in vitro study demonstrating that the Company’s LentiVector system can be used to deliver therapeutic genes safely and effectively to human corneal endothelial cells. Hence, the LentiVector system may have application in the development of gene-based therapies for the treatment of corneal endothelial disorders such as Fuchs’ dystrophy. This inherited disease affects about % of the population, and leads to gradual loss of vision as the inner layer of the cornea degenerates. Today, the only real cure for Fuchs’ dystrophy is a cornea transplant.

Oxford BioMedica and Johns Hopkins University, with support from the Foundation Fighting Blindness and its translational-oriented subsidiary, the National Neurovision Research Institute (NNRI), are conducting further preclinical studies with RetinoStat and commencing manufacturing scale-up and non-clinical studies to support the start of clinical trials. The Company is on track with its objective to start clinical trials of RetinoStat in wet AMD in 2007.

“We are very encouraged by the results of this successful collaboration,” said Stephen Rose, Ph.D., Foundation Fighting Blindness’ Chief Research Officer. “We created the National Neurovision Research Institute subsidiary to work with both commercial and academic institutions to move promising treatments like RetinoStat into clinical trials. As a constituent-driven organisation, we have a strong commitment to getting treatments to market and the people that need them. We look forward to further collaborations with Oxford BioMedica on this and other projects to bring treatments and cures to patients with a variety of retinal degenerative diseases.”

Oxford BioMedica’s Chief Executive Officer, Professor Alan Kingsman, commented: “The data being presented at ARVO not only demonstrate the potential of RetinoStat as a treatment of retinopathy but also highlight the potential of our LentiVector system to treat other ocular diseases. Oxford BioMedica is pleased to be working with Johns Hopkins University and also to have the support of the Foundation Fighting Blindness. The new data suggest that a single injection of RetinoStat could provide long-term shut-down of aberrant blood vessel growth, and hence, could offer a safe, effective and more convenient treatment than current approaches for wet AMD as well as diabetic retinopathy, another leading cause of blindness. Given the world’s aging population, there is a growing need to find better treatments for these conditions.”

Notes
. Oxford BioMedica plc

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 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 70 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, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.
2. RetinoStat®

RetinoStat is Oxford BioMedica’s novel gene-based treatment for wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). The product uses the LentiVector system to deliver genes to the retina that block the formation of new blood vessels. Oxford BioMedica has exclusive rights to two proprietary anti-angiogenic genes, angiostatin and endostatin, for use in treatments of ocular diseases under a licensing agreement with Entremed Inc. The Company has evaluated both genes in its RetinoStat programme. The optimised version of the product, which will proceed to clinical development, carries both the angiostatin and endostatin anti-angiogenic genes and shows significantly greater efficacy than versions containing single genes. Preclinical development is being conducted in collaboration with the Institute of Ophthalmology, London, UK, and Johns Hopkins University School of Medicine, Baltimore, Maryland, USA, with support from the Foundation Fighting Blindness. The Company plans to start clinical trials with RetinoStat in wet AMD in 2007.

TroVax is currently in five Phase II trials, including an investigator initiated trial sponsored by Cancer Research UK. Over 100 patients have been treated with TroVax (collectively over 400 doses) in five clinical trials in colorectal cancer and renal cell carcinoma. Clinical results have shown that the product is safe and stimulates an anti-tumour immune response against 5T4 in the majority of patients. Data from the completed Phase I/II trial and ongoing Phase II trials suggest that the magnitude of the immune response induced by TroVax correlates with clinical benefit including tumour responses and time to disease progression, both of which have exceeded expectation based on published historical data. Preliminary analysis of data from Phase II trials in colorectal cancer with chemotherapy indicates a potential survival benefit. A Phase III trial in renal cell carcinoma is planned to start in 2006.
3. Age-related macular degeneration and other retinopathies

Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are major causes of blindness in the developed world. AMD affects an estimated 25-30 million people in the western world and DR affects approximately 50% of all Americans diagnosed with diabetes. It is estimated that there are 17 million diabetics in the USA. AMD is the most common cause of visual loss in the elderly. DR is the most common cause of visual loss in the working population and is the most common cause of acquired blindness in people under 60 in the developed world.

Both wet AMD, the form of AMD which accounts for 90% of all severe vision loss from the disease, and DR are caused by aberrant growth of leaky and disruptive blood vessels in the retina. This growth is caused by a hyper-response to localised regions of low oxygen arising from compromised blood supply within the retina. Oxford BioMedica has shown that its LentiVector technology can target these regions of the eye with great accuracy and deliver anti-angiogenic proteins to treat these diseases.

Analysts’ estimates, published in the Wall Street Journal, suggest that sales of an effective treatment for macular degeneration could exceed US$ billion per annum.
4. The Foundation Fighting Blindness

The Foundation Fighting Blindness, Inc. (FFB) has a mission to drive the research that will provide preventions, treatments and cures for people affected by retinitis pigmentosa, macular degeneration, Usher syndrome, and the entire spectrum of retinal degenerative diseases. The Foundation has funded thousands of research studies at hundreds of prominent institutions. The Foundation funds leading-edge research in promising areas such as genetics, gene therapy, retinal cell transplantation, artificial retinal implants, and pharmaceutical and nutritional therapies. Since its inception in 1971, the Foundation has raised over US$240 million. FFB is ranked as a “Top-Rated” charity by the American Institute of Philanthropy and was named one of Worth Magazine’s “100 Best Charities.”

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