First Clinical Trials

Oxford Biomedica PLC
6 November 2000


For further information, please contact: 
      
Oxford BioMedica plc       
Professor Alan Kingsman, Chief Executive       Tel: [phone]

City/Financial Enquiries:
David Simonson/Melanie Toyne Sewell            Tel: [phone]
Merlin Financial Communications       

Scientific/Trade Press Enquiries:
Sue Charles/Chris Gardner, HCC De Facto Group  Tel:  [phone]


OXFORD BIOMEDICA ANNOUNCES FIRST CLINICAL TRIAL RESULTS FOR ITS CANCER
THERAPEUTIC, METXIA(R).

Oxford, UK; November 6, 2000 - Oxford BioMedica announced today the successful
completion of the first part of its BC1 clinical trial of its anti-cancer
product, MetXia(R). The product was safe and well tolerated and resulted in
gene transfer to the tumours. These results represent the achievement of all
of the major goals of the first part of the trial and mean that the clinical
development of the product will continue as planned with the second part of
the trial expected to report in 2001. In addition, the Company plans to expand
the use of MetXia(R) in a number ways, thereby broadening the commercial
potential of the product.

BioMedica's MetXia(R) product is designed for direct administration to any
solid tumours. Although the BC1 protocol focused primarily on late stage
breast cancer patients with readily accessible nodular skin tumours it also
allowed inclusion of any patient with similar nodules arising from other
cancers. As a result three melanoma patients were included in the trial. A
total of eight patients were treated with three doses of MetXia(R). Gene
transfer was achieved in all patients and MetXia(R) appeared to be safe and
well tolerated throughout the dose range.

MetXia(R) is the first product of its type to be produced in human cells, a
strategy that is designed to lead to greater stability of the product in the
patient and therefore, higher levels of gene transfer. In the past the
production of gene therapy products using animal cells has compromised product
stability which has resulted in undetectable levels of gene transfer. The
current results indicate that this strategy is being successful. 

MetXia(R)represents a platform technology for increasing tumour cell death via
the local activation of the prodrug, cyclophosphamide. The Company has plans
to develop MetXia(R) in a number of ways; firstly as a product in its own
right, secondly as a component of a combination product that induces the
immune system to destroy tumours and finally, in selected formulations to
achieve tumour targeting. The current clinical trial deals with the first of
these approaches.

Commenting on the trial results and the deal, Chief Executive, Prof. Alan
Kingsman said;
'We are delighted with these results, they are excellent, but we must remember
that MetXia(R) is still at an early stage in its clinical evaluation. There
are some very important results yet to be achieved before MetXia(R) becomes a
true success. However, the potential value of MetXia(R) is high and we look
forward to the next exciting stages of the development of this product
series.'


Notes to Editors

1.       Oxford BioMedica plc
Established in 1995, the Company specialises in the development and
application of gene-based therapeutics and immunotherapeutics for the
treatment of disease in the areas of Oncology, Viral Infection, and
Neurobiology and in gene-discovery. Oxford BioMedica plc was floated on the
Alternative Investment Market of the London Stock Exchange in December 1996.
Currently Oxford BioMedica has corporate collaborations with Aventis,
AstraZeneca, IDM, Modex Therapeutics, Nycomed Amersham and Virbac. BioMedica's
first clinical product, MetXia(R) is in Phase I/II clinical trials for
late-stage breast cancer (BC1) and ovarian cancer (OC1). Recently it received
ethical approval form the UK Gene Therapy Advisory Committee for a Phase I/II
clinical trial of its cancer vaccine TroVax(TM) in colorectal cancer. The
clinical programme is expected to commence around the end of 2000.

2.        MetXia(R) gene therapy for cancer
A common strategy for the treatment of cancer is to administer cytotoxic (or
cell killing) drugs in an attempt to destroy the tumour. Cyclophosphamide is
one of a group of drugs that is taken by the patient in the form of an
inactive prodrug. The prodrug travels through the body to the liver where
enzymes convert it to the active, cytotoxic form. This approach affects the
whole body and leads to the familiar adverse side effects of cancer
chemotherapy because the cytotoxic drug destroys normal cells on its way from
the liver to the tumour. In addition, because the activating enzymes are
present only in the liver, high doses of prodrug must be given to achieve
therapeutic levels of the cytotoxic drug at the tumour site. Often the
therapeutic effect is compromised by the toxicity.

Oxford BioMedica's MetXia(R) addresses these problems by delivering the gene
(CYP2B6) directly to the tumour. Once incorporated into the genetic material
of the tumour cells, this gene produces the liver enzyme that converts the
cyclophosphamide pro-drug to its active form within the tumour. The aim is to
achieve high concentrations of activated cyclophosphamide locally in the
tumour while minimising circulating levels of the drug. It is anticipated that
this will lead to substantially increased sensitivity of the tumour to the
drug and to an ability to reduce the dose of cyclophosphamide, thereby
reducing adverse side effects. 

In a variety of preclinical models, BioMedica has shown that delivery of the
human CYP2B6 gene to tumours, using MetXia(R), does indeed increase their
sensitivity to cyclophosphamide and leads to enhanced tumour cell killing. The
Company is now engaged in Phase I/II clinical trials in breast cancer (BC1)
and ovarian cancer (OC1). The results reported today confirm that the gene
transfer achieved in preclinical models also occurs in the cancer patients in
the BC1 trial. The implication for the efficacy of the product of this level
of gene transfer will be evaluated in further studies. 
 
3.       World Wide Web
This release is also available on the World Wide Web at
http://www.oxfordbiomedica.co.uk