Positive Results from MetXia Phase I/II Breast Cancer Trial and Plans for Pancreactic Cancer Trial

Oxford, UK: 3 July 2003 - Oxford BioMedica (LSE:OXB) announced today encouraging results from its ongoing Phase I/II trial with MetXia^® in breast cancer patients. The Company also announced regulatory progress towards starting a Phase I/II trial with MetXia in pancreatic cancer.

The current Phase I/II trial in breast cancer is using an improved formulation of MetXia that effectively increases the dose level. One of the goals of the trial is to show that this higher potency form is safe. The trial is also designed to confirm the encouraging responses observed in an earlier clinical trial of the original formulation of MetXia in breast cancer and melanoma patients. The ongoing trial seeks to confirm the immune stimulatory properties of MetXia as well as to determine whether the higher potency version of the product delivers the therapeutic gene to tumours more efficiently in humans, as it does in preclinical models. So far, the data suggest that MetXia is meeting all expectations with respect to safety, gene transfer and immune stimulation.

The patient recruitment for the low dose is now complete and data from the first patients show that delivery of the therapeutic gene to tumour cells is more than 10-fold better than in the previous trial and also that patients are mounting an anti-tumour immune response. If this high level of response to MetXia is maintained, there will be no need to recruit all 12 patients and the study can be terminated early. Furthermore, if the systemic anti-tumour effect is a reproducible feature of MetXia as the trial continues, then the product could be considered for treatment of disseminated metastatic disease, which would greatly enhance its commercial potential.

In addition, the Company has proceeded with its plans to take MetXia into a Phase I/II study in pancreatic cancer by seeking approval for the trial from the UK Gene Therapy Advisory Committee (GTAC). GTAC is currently considering the application. The proposed trial is expected to enrol 25 patients who have previously been diagnosed with metastatic pancreatic cancer. The trial will be conducted at the Royal Liverpool University Hospital and Leicester Royal Infirmary.

Commenting on progress with MetXia, Oxford BioMedica’s Chief Executive, Prof Alan Kingsman said “The new data are most encouraging. If they are confirmed in a few additional patients then we can expand the potential market for MetXia based on its systemic anti-cancer effects. Notwithstanding these results, we are pleased to be making progress towards our first trial in pancreatic cancer, a disease where there is a clear unmet medical need and accelerated product approval is a possibility.”

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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.	MetXia
	MetXia is Oxford BioMedica’s leading gene-based cancer therapeutic. The product is based on a highly engineered retrovirus gene delivery system expressing a specific human cytochrome P450 gene. MetXia converts the tumour into a ‘drug factory’, enabling increased local production of the anti-tumour, cytotoxic derivative of the pro-drug cyclophosphamide. MetXia is potentially useful in the treatment of all solid tumours and their metastases, particularly those where cyclophosphamide is commonly used. Results from an initial Phase I/II trial of MetXia in patients with very advanced breast cancer or melanoma were reported last year. The trial was completely successful in that the product was safe and gene delivery was readily detected in the treated tumours. In addition there was clinical benefit in some patients, including tumour size reduction. Most remarkable, however, was the dramatic improvement in one patient of a cancerous lesion that was not treated, following treatment of tumour nodules elsewhere on the patient’s body. One interpretation of these data is that MetXia was inducing a systemic immune response, which acted against the untreated lesion. Subsequent studies demonstrated that this patient did indeed have anti-tumour antibodies and T-cells. This means that although MetXia must be administered directly to a tumour, the tumour cell death that it causes may induce an immune response that will destroy other tumours in the same patient.
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