Regulatory Approval

Oxford Biomedica PLC 29 April 2004 FOR IMMEDIATE RELEASE 29 APRIL 2004 OXFORD BIOMEDICA GAINS FDA APPROVAL FOR A PHASE II TRIAL OF TROVAX(R) IN RENAL CANCER - Patient Recruitment to Commence Q3 2004- Oxford, UK: 29 April 2004 - Oxford BioMedica (LSE:OXB.L), the leading gene therapy company, announces today that the US Food & Drug Administration (FDA) has approved an Investigational New Drug (IND) application to evaluate TroVax(R), the Company's proprietary cancer vaccine, in patients with metastatic renal cancer. TroVax(R) will be tested in combination with the standard treatment interleukin- 2 (IL-2), an immune stimulator, in patients whose median survival is approximately 13 months. Safety and immunogenicity will be the primary goals, but patients will be monitored for clinical benefit including increased survival. The trial will be conducted at the Columbia Presbyterian Medical Center in New York and patient recruitment is expected to start in Q3 2004. The study should be complete, as far as the primary end-points are concerned, within approximately twelve months of initiation. There were an estimated 31,900 new cases of renal cancer in the US in 2003 (source: American Cancer Society, Cancer Facts and Figures for 2003). More than half of these patients have metastatic disease (secondary cancer). After surgical removal of the primary tumour, treatment with IL-2 has been shown to have some benefit, suggesting that the tumours may be responsive to immunological strategies. The rationale for this trial is that the immune response induced by TroVax(R) may halt or delay the progression of metastases so increasing survival beyond the estimated median of 13 months. Using TroVax(R) in combination with IL-2 may enhance that response. There is a great need for additional therapies for renal cancer as the prognosis for patients is poor with current treatments. The regulatory strategy for the development of TroVax(R) will involve seeking fast track approval and opening discussions about product registration if early data are encouraging. Commenting on the approval Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: 'We are delighted to be able to take TroVax(R) into the USA in an indication that has real unmet medical need. We expect patient recruitment to be faster than we have seen in previous trials and we are excited about testing TroVax(R) with an immune stimulator such as IL2.' -Ends- For further information, please contact: Oxford BioMedica plc ---------------------- Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: ---------------------- Lisa Baderoon/ Mark Court: Buchanan Communications Tel: +44 (0)20 7466 5000 ---------------------- Scientific/Trade Press Enquiries: Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7886 8150 Notes to editors 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. In addition to its technical expertise in gene delivery, Oxford BioMedica has in-house clinical, regulatory and manufacturing know-how. The development pipeline includes two novel anti-cancer products in clinical trials; and two neurotherapy products in advanced preclinical development for Parkinson's disease and retinopathy. The Company is underpinned by an extensive preclinical and research portfolio and about 70 patent families, which represents 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, Merck & Co, Amersham and Kiadis. Further information is available at http://www.oxfordbiomedica.co.uk 2. TroVax(R) 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. Approval has now been obtained for a Phase II trial in the USA in renal cancer. The product is also expected to enter further trials in colorectal 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 quarter 3 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. This information is provided by RNS The company news service from the London Stock Exchange
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