Oxford BioMedica’s TroVax^® Receives Clearance from the United States Recombinant DNA Advisory Committee to Enter a Clinical Trial for Renal Cancer

Oxford BioMedica announced today that TroVax had passed a key regulatory hurdle towards its first clinical trial in the USA. A review by the United States Recombinant DNA Advisory Committee (RAC) provided clearance to start a clinical trial with TroVax for the treatment of renal cancer. The trial will be conducted at the Columbian Presbyterian Medical Center in New York.

TroVax is Oxford BioMedica’s leading cancer immunotherapy product. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a pox virus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4 protein.

Following successful Phase I/II clinical trial results in late stage colorectal cancer patients in the UK, TroVax is proceeding into Phase II trials in colorectal cancer and into further trials in renal and breast cancer respectively. Both the renal and breast cancer trials are to be conducted in the United States under an Investigative New Drug (IND) application. A prerequisite for the IND is approval by RAC.

Renal cancer represents a significant market opportunity with about 30,000 cases per year in the United States. It is generally treated with Interleukin 2 (IL2). However, the success rate is mixed and median survival is only about 13 months. There is therefore a significant unmet medical need for an improved therapy for this type of cancer. TroVax is to be tested with IL2 in a study of 25 patients. Safety, immunogenicity and clinical benefit will be the primary objectives of the trial.

Commenting on the news the Company’s Senior Vice President for Research and Development, Dr. Susan Kingsman said "Survival rates for renal cancer are poor and there are few novel therapies in development for this disease. We are delighted that TroVax is proceeding towards its first clinical trial in the United States for this unmet medical need. This is an important step in broadening the market potential of the product and thereby increasing its value”.

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Notes

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® 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®, 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.
2.	The US Recombinant DNA Advisory Committee
	The Recombinant DNA Advisory Committee (RAC) was established on October 7, 1974, in response to public concerns regarding the safety of manipulation of genetic material through the use of recombinant DNA techniques. The RAC advises the Director of the US National Institutes of Health. The RAC is a technical committee whose goal is to consider the current state of knowledge and technology regarding recombinant DNA. This includes review of human gene transfer trials, and an assessment of the ability of DNA recombinants to survive in nature and the potential for transfer of genetic material to other organisms. It also considers hypothetical hazards and methods for monitoring and minimizing risks. Approximately one-third of the 15 members do not have scientific expertise but represent public interests and attitudes. This balance is intended to provide a forum for open public debate of social and scientific issues attendant to recombinant DNA research. The RAC has been overwhelmingly successful in achieving this goal.
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 Enquiries Sue Charles, Katja Stout, College Hill - Life Sciences Tel: +44 (0)20 7886 8150