Oxford BioMedica's TroVax receives approval to start Phase II trials in colorectal cancer
Oxford , UK : 16 January 2004 – Oxford BioMedica announced today that Cancer Research UK (CR UK ) had received approval from the Gene Therapy Advisory Committee (GTAC) to conduct a Phase II study of TroVax in colorectal cancer patients who are to undergo surgery for resectable liver metastases.

Twenty Stage IV patients will receive injections of TroVax followed by surgery approximately ten days later.  Biopsies of the tumour will be taken at surgery and analysed for TroVax stimulated immune activity. Further vaccinations will be given after surgery. Patients’ management will then continue as standard and they will be followed after the final vaccination to assess immune responses and toxicity and then monitored over the longer term for clinical benefit. In August 2003, Oxford BioMedica announced that Cancer Research UK had agreed to conduct and sponsor this open label Phase II trial. The decision by Cancer Research UK followed extensive review of the successful Phase I/II data of TroVax in colorectal cancer patients.

Commenting on the news Oxford BioMedica’s Chief Executive, Prof. Alan Kingsman said “This is the third Phase II TroVax study that has been approved by GTAC and we are delighted to be working with Cancer Research UK in this important aspect of colorectal cancer.”

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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.

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 www.oxfordbiomedica.co.uk  

2. TroVax^® cancer immunotherapy

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 poxvirus (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.

Two Phase I/II trials with TroVax have been completed in the UK in late-stage colorectal cancer patients. Following these successful Phase I/II trials, TroVax has entered two Phase II trials in the UK in Stage IV colorectal cancer patients receiving 5FU plus either oxaliplatin or irinotecan. The product is also expected to enter further trials in colorectal, renal and breast cancer. The renal and breast cancer trials are to be conducted in the United States under an Investigational New Drug (IND) application. The renal cancer trial in the US is expected to start enrolment in early 2004. Initial data from the first TroVax Phase II trial in colorectal cancer have confirmed the product’s safety profile. Full results from the colorectal cancer Phase II trials are anticipated in 2004.

3. Cancer Research UK

Cancer Research UK began operating on 4 February 2002 as a result of the merger between The Cancer Research Campaign and Imperial Cancer Research Fund. Its vision is to conquer cancer through world-class research. It is the largest volunteer-supported cancer research organisation in the world with a dedicated team of 3,000 scientists and an annual scientific spend of more than £176 million. Its objectives, amongst others, are to: carry out world class research into cancer; develop better treatments for cancer patients; improve the quality of life of cancer patients; reduce the number of people getting cancer; improve training and support of cancer research workers; and provide authoritative information and advocacy on cancer. 

For further information, please contact:

Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive, +44 (0)1865 783 000

City/financial enquiries: Mike Wort/James Chandler, Beattie Financial, +44 (0)20 7398 3300

Scientific/trade press enquiries: Katja Stout/Sue Charles, Northbank Communications, +44 (0)20 7886 8150