Oxford , UK : 27 November 2003 – Oxford BioMedica announced today that the US non-profit organisation, The Foundation Fighting Blindness (FFB), has agreed to fund preclinical proof-of-principle studies for the Company’s vision-loss product RetinoStat^TM. The product is comprised of Oxford BioMedica’s LentiVector gene delivery system expressing an angiostatic gene under the control of its proprietary gene switch that promotes gene expression specifically in ischaemic (low oxygen) ocular tissue. The preclinical studies will be carried out at the Wilmer Eye Institute, Johns Hopkins University in Baltimore , Maryland , under the direction of one of the world’s leading clinical ophthalmologists, Prof Peter Campochiaro. Data from these studies will be pivotal to moving the product into clinical trials and will also provide the Company with a powerful marketing package with which to attract partners.

 

Prof Campochiaro is a world leader in the development of preclinical models for age-related macular degeneration (AMD), the most common cause of vision-loss in the developed world.  These preclinical models will be used to help define the safety and efficacy of RetinoStat^TM. Prof Campochiaro has shown already that endostatin, the angiostatic gene in RetinoStat^TM, is effective in treating choroidal neovascularisation, the major cause for severe vision-loss in patients with AMD.

 

Commenting on the news, Oxford BioMedica’s Chief Executive, Prof Alan Kingsman said “We are delighted to be working alongside the FFB who have unrivalled expertise in facilitating the development of novel products for vision-loss. Support from the FFB will help RetinoStat™   move more quickly towards clinical evaluation. RetinoStat^TM is the fourth product in Oxford BioMedica’s pipeline that has achieved financial backing from independent expert research organisations”.

 

Dr Gerald J. Chader, Chief Scientific Officer of the FFB commented “The urgent mission of the FFB is to prevent, treat or cure retinal degenerations such as AMD. For this purpose, we seek collaborations with the best biopharmaceutical companies. With its excellent leadership, innovative technology and clinical trial experience in the cancer field, Oxford BioMedica is certainly such a company. Most importantly, because of its novel vector, gene cargo and response element used to control gene expression, RetinoStat™ has all the characteristics of a successful angiostatic product.”

-Ends-

 

Notes to editors

 

1.   Oxford BioMedica

 

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of gene-based products for a range of unmet medical needs with an emphasis on new cancer products, which combine novel mechanisms of action with very low side effects, and innovative neurotherapy products, which address large and, in several areas, untapped markets. The products are all protected by multiple patents comprising a total intellectual property portfolio of some 69 patent families, which represents one of the broadest patent estates in the field.

 

In addition to its technical research skill-base, Oxford BioMedica has in-house clinical, regulatory and manufacturing know-how. The development pipeline includes two novel anti-cancer products in clinical trials and a gene-based treatment for Parkinson’s disease, which is in late preclinical studies.

 

TroVax^®, Oxford BioMedica’s lead cancer immunotherapy product, is in Phase II trials for colorectal cancer. Further Phase II trials are planned for breast and renal cancer. MetXia^®, Oxford BioMedica’s lead gene-based cancer therapeutic, is based on a highly engineered retrovirus gene delivery system expressing a specific human cytochrome P450 gene. MetXia is being investigated in a Phase I/II trial in breast cancer, and regulatory submissions are under review for trials in pancreatic cancer.

 

Oxford BioMedica has a wholly owned subsidiary in San Diego , USA . Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Amersham, Arius Research, Kiadis and Viragen.

 

Further information is available at http://www.oxfordbiomedica.co.uk

 

2.   RetinoStat™ for Vision-Loss

 

The main causes of vision-loss in the developed world are age-related macular degeneration (‘AMD’) and diabetic retinopathy (‘DR’). These conditions affect approximately 30 million people in the US and Europe 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 and prevent it recurring. The current treatments for AMD and DR tend only to slow the diseases’ progression. 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. The Company has an exclusive licence to use EntreMed’s proprietary angiostatic proteins, endostatin and angiostatin, for the treatment of ocular diseases via localised gene delivery. Endostatin and angiostatin both target multiple stages of the angiogenesis process, specifically targeting aberrant blood vessels, leaving normal vessels unaffected.

 

3.   Foundation Fighting Blindness

 

The Foundation Fighting Blindness (www.blindness.org) is the largest non-governmental source of funding for retinal degenerative disease research in the world. The Foundation funds more than 150 research projects at more than 55 prominent institutions around the world. With an “A” rating, The Foundation Fighting Blindness (FFB) is ranked as a “Top-Rated” charity by the American Institute of Philanthropy.

 

 

4.       The Wilmer Eye Institute

 

Named after William Holland Wilmer, M.D., who in 1925 left his Washington, D.C., practice to establish a comprehensive eye center at Johns Hopkins, the Wilmer Eye Institute is home to faculty who are credited with the development of one of the original argon lasers used to halt vision loss caused by diabetes, age-related macular degeneration and other diseases; showing that blindness in premature infants could be prevented by reducing excess oxygen in incubators; perfecting extended-wear contact lenses and pioneering the specialty of neuro-ophthalmology as well as establishing the country's first centers for genetic eye disease and preventive ophthalmology.  Wilmer has been ranked as the country's #1 eye department by US News & World Report and Ophthalmology Times magazines, and has the highest level of funding from the National Eye Institute of any ophthalmology department in the US .