Research Update

Oxford Biomedica PLC
24 October 2003


For immediate release                                               2003/OB/19
24 October 2003

For further information, please contact:

Oxford BioMedica plc
----------------------
Professor Alan Kingsman, Chief Executive            Tel: [phone]

City/Financial Enquiries:
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Mike Wort, James Chandler: Beattie Financial        Tel: [phone]
                                                                     
Scientific/Trade Press Enquiries:
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Sue Charles, Katja Stout: Northbank Communications   Tel: [phone]
                                                                     





   OXFORD BIOMEDICA RECEIVES Approval FROM GTAC For MetXia(R) to enter Clinical
                          trials IN pancreatic cancer



Oxford, UK - 24 October 2003: Oxford BioMedica plc announced today that it has
received approval from the UK's Gene Therapy Advisory Committee ('GTAC') for
MetXia to enter a two-stage Phase I/II clinical trial in patients with
pancreatic cancer. Two leading clinical centres in Liverpool and Leicester have
supported this regulatory application and plan to commence recruitment before
the end of the year.


The trial will be an open label study and will initially recruit six patients to
assess the safety of MetXia and to identify the optimal dose for the second
stage. In the second part of the trial, the cyclophosphamide prodrug will be
gradually escalated to identify a maximum tolerated dose. Up to 21 patients will
be recruited and endpoints include safety, clinical response and time to disease
progression.


MetXia is also being investigated in breast cancer patients and a second Phase I
/II trial in breast cancer is ongoing. The broadening application of MetXia into
pancreatic cancer is an important development for this novel anticancer agent.
The ongoing Phase I/II breast cancer trial continues to support our initial
clinical findings that MetXia is safe, well tolerated and offers potential
clinical benefit. In the proposed pancreatic cancer study MetXia will be
delivered directly to the pancreatic tumour via an intra-arterial catheter
together with the cyclophosphamide prodrug. Unlike oral administration of
cyclophosphamide used in the breast cancer trials, this strategy avoids the
initial metabolism of cyclophosphamide in the liver, thereby maximising its
localised activation in the pancreatic tumour. This clinical protocol,
therefore, could enhance the potential efficacy of MetXia.

Pancreatic cancer is amongst the most aggressive with median survival time of
only 6-12 months from diagnosis for inoperable cancers. Current treatment
options are primarily based on the chemotherapeutic agents 5-fluorouracil and,
more recently, gemcitabine. However, these have a minimal effect on median
survival underlining the need for novel therapeutic strategies. Given the short
survival times and the lack of therapeutic options for this disease, positive
data from this trial could lead to accelerated approval for MetXia in this
indication.



Commenting on this news, Chief Executive Professor Alan Kingsman said:


'This is the first in a series of applications of MetXia following on from the
successful Phase I/II trials in late-stage breast cancer patients. Success in
pancreatic cancer should accelerate MetXia's commercial development.'


Ends-



Notes to Editors


1.         Oxford BioMedica plc

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development of gene-based products for a range of unmet medical needs with an
emphasis on new cancer products, which combine novel mechanisms of action with
very low side effects, and innovative neurotherapy products, which address large
and, in several areas, untapped markets. The products are all protected by
multiple patents comprising a total intellectual property portfolio of some 69
patent families, which represents one of the broadest patent estates in the
field.


In addition to its technical research skill-base, Oxford BioMedica has in-house
clinical, regulatory and manufacturing know-how. The development pipeline
includes two novel anti-cancer products in clinical trials and a gene-based
treatment for Parkinson's disease, which is in late preclinical studies.


TroVax(R), Oxford BioMedica's lead cancer immunotherapy product, is in Phase II
trials for colorectal cancer. Further Phase II trials are planned for breast and
renal cancer. MetXia(R), Oxford BioMedica's lead gene-based cancer therapeutic, 
is based on a highly engineered retrovirus gene delivery system expressing a
specific human cytochrome P450 gene.


Oxford BioMedica has a wholly-owned subsidiary in San Diego, USA. Oxford
BioMedica has corporate collaborations with Wyeth, Intervet, Aliga
Pharmaceuticals, Amersham, Arius Research and Viragen.


Further information is available at http://www.oxfordbiomedica.co.uk



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 addresses these problems by delivering a specific
human cytochrome P450 gene (CYP2B6) directly to the tumour using a highly
engineered retrovirus gene delivery system. 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.


MetXia has completed one Phase I/II trial in 12 late stage breast cancer and
melanoma patients. The product was found to be safe, well tolerated and showed
some clinical benefit. In addition to local effects on tumour nodules that had
been treated with MetXia, there was evidence of induction of systemic
anti-tumour immune responses. A second Phase I/II study, using a higher potency
version of MetXia is close to completion. In the lower dose group, data 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, confirming the observations made in the first
trial. The product continues to be safe, even at the higher potency.



3.             Gene Therapy Advisory Committee (GTAC)

The Gene Therapy Advisory Committee evaluates gene therapy trial protocols on
the basis of the quality of the science, the details of the clinical protocol
and ethical considerations. GTAC comprises technical experts and lay members.


Following GTAC approval, clinical trial protocols and the products used by them
are then reviewed by the Medicines and Healthcare products Regulatory Agency
(MHRA). On approval by the MHRA, the products can be entered for clinical
trials.

                      This information is provided by RNS
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