Positive Clinical Trials

Oxford Biomedica PLC 11 July 2002 OXFORD BIOMEDICA'S TROVAX(R) POISED TO ENTER PHASE II TRIALS Positive Results for Therapeutic Cancer Vaccine Oxford, United Kingdom - 11 July 2002. Oxford BioMedica plc (LSE:OXB) will today release additional data from its Phase I/II clinical trial of TroVax(R) at the Society for Cancer Gene Therapy Conference in London. The data, from colorectal cancer patients receiving medium and high doses show that they tolerated the product well with no adverse reactions being observed. In addition, the results demonstrate that TroVax(R) is extremely efficient at inducing the appropriate immune response with all of the ten immunocompetent patients analysed to date in the trial mounting a specific response against the tumour antigen OBA1, the active component of TroVax(R), and some patients showing reductions in levels of circulating tumour marker proteins that are used as indicators of tumour load. The new data reinforces the observations previously reported for the low dose group. The trial has been a complete success and TroVax(R) will proceed to the next stage of clinical development. TroVax(R) is a gene-based therapeutic vaccine that is designed to stimulate the patient's immune system to recognise and destroy cancer cells. The product is based on a gene that encodes a protein, OBA1, that exists on the surface of tumour cells and not on normal cells - such proteins are known as Tumour Associated Antigens (TAAs). When the OBA1 gene is expressed by Oxford BioMedica's highly engineered virus-based delivery system, it induces an anti-tumour response. OBA1 is present on a wide range of tumours, thus whilst the first clinical trials of TroVax(R) have been conducted in colorectal cancer patients, TroVax(R) is also expected to be applicable to many other solid tumours. The Phase I/II study described today was designed primarily to assess safety and immunogenicity of TroVax(R) in twelve patients. As is the case with all early stage cancer trials, the patients were at a relatively advanced stage in the disease. All twelve patients have been recruited and treated with TroVax(R). As reported previously, one of the patients in the low dose group was unable to mount an immune response to any test antigen during the study and so was not included in the immunological evaluation of TroVax(R). One other patient is part-way through their treatment and their immune responses have not been analysed fully to date. The remaining 10 patients all responded to TroVax(R) by mounting an immune response to the tumour protein OBA1. It is this response that is anticipated to have a beneficial effect. In several patients the induction of the immune response was correlated with reductions in circulating markers of tumour load. In the current trial patients were recruited after they had completed chemotherapy treatment. In the next trial it is likely that the product will be tested on patients who are at a somewhat earlier stage in the disease process. Although still in the planning stage, it is likely that the next trial will be a phase II study, in which TroVax(R) will be assessed in colorectal cancer patients while they are undergoing chemotherapy. This patient group would be the first target market for TroVax(R). Subsequently the therapy may be used in other tumours and at an earlier stage. The market potential for TroVax(R) is substantial as an addition to existing cancer treatment regimens. Approved drugs such as irinotecan, which have been shown to extend survival by a few months, have achieved global sales in excess of $500 million as an addition to standard 5-FU chemotherapy. Commenting on the results presented today Oxford BioMedica's Chief Executive, Prof. Alan Kingsman said: 'We are delighted that the TroVax(R) trials have been so successful with such encouraging results. It is unusual for a vaccine, particularly a cancer vaccine, to elicit an immune response in all patients. We believe that we have achieved a significant step towards TroVax(R) progressing successfully to the market'. 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 Press Enquiries: Sue Charles, Katja Stout: Charles consultants Tel: +44 (0)20 7321 3870 Notes to Editors Oxford BioMedica plc Established in 1995 as a spin out from Oxford University, Oxford BioMedica is an international biotechnology company with a diverse portfolio of products and technology, specialising in gene-based products and technology in the areas of cancer, neurological disease, cardiovascular disease and blood disorders. This is underpinned by over 60 patent families, about quarter of which are issued. 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. Oxford BioMedica is headquartered in Oxford, UK and has a wholly-owned subsidiary in San Diego, USA. Currently Oxford BioMedica has corporate collaborations with Aventis, IDM, Nycomed Amersham, Valentis, Virbac and Wyeth. BioMedica has two products in Phase I/II clinical trials: MetXia(R) for late-stage breast cancer, and TroVax(R) for late-stage colorectal cancer. World Wide Web Further information is available on the World Wide Web at http:// www.oxfordbiomedica.co.uk This information is provided by RNS The company news service from the London Stock Exchange
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