Oxford Biomedica Plc - Interim Results for Metxia(R) and Trovax(R)

22-Feb-2002

Oxford, United Kingdom - 20 February 2002. Oxford BioMedica plc presented today at the Beeson Gregory Cancer Therapies Conference interim results from the Company's Phase I/II trials of its cancer products, MetXia® and TroVax®. The trials were designed primarily to assess safety; the measurement of efficacy was not part of the trials. However a number of clinical improvements were observed.

MetXia® is a potential treatment for a range of solid tumours. In the MetXia® BC1 trial, mostly in patients with advanced breast cancer, a number of tumours that were treated with the product reduced in size. In addition, in one patient where the treated tumour had substantially reduced in size, a cancerous lesion that had not been treated directly showed marked improvement. This was associated with indications of an anti-tumour immune response, which suggest that administration of MetXia® to one tumour in a patient may elicit an anti-tumour immune response that can destroy other tumours in the same patient. If this proves to be the case, MetXia® could be developed for use as a systemic treatment for cancer, broadening its market potential. The MetXia® trial programme is continuing and now includes additional monitoring of the immunological status of the patients in order to test this hypothesis.

In October 2001 BioMedica reported initial results from the low dose patient group in its TroVax® trial in patients with advanced colorectal cancer. TroVax® is a therapeutic anti-cancer vaccine that seeks to trigger an immune response against tumours. In the low dose group, all three of the immunocompetent patients showed a clear immune response stimulated by TroVax®. The Company has now disclosed that two of those three patients showed clinical improvements. In one patient, there was a clear correlation between increased immune response to TroVax® and a significant reduction in the levels of a surrogate marker, which is indicative of decreased tumour load. In addition, from CT scans of this patient, it was apparent that a considerable portion of the centre of a large inoperable mesenteric tumour had become necrotic. This result was evident 12-20 weeks after the patient received the first injection of TroVax®. In a second patient with a large, actively growing liver metastasis, a TroVax®-induced immune response was coincident with a period of disease stabilisation.

Commenting on these results BioMedica's Chief Executive, Prof. Alan Kingsman said "These interim data are interesting and provide a useful basis for future trials. However, we are aware that, because of the small size of the trial groups and the advanced stage of disease amongst the patients, further studies are required before firm conclusions can be made about the efficacy of both MetXia® and TroVax®."

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