OXFORD BIOMEDICA
PLC
Oxford BioMedica releases pre-clinical data on MetXia-P450,
the Company's first product to go into clinical trial
At
the 2nd Annual Meeting of the American Society
of Gene Therapy, the largest and most prestigious annual gathering
of gene therapy professionals, held in Washington D.C., Oxford
BioMedica scientists described preclinical data that has resulted
in the Company's first product, MetXia-P450TM,
entering clinical development for the treatment of advanced
breast cancer. The audience consisted of the leading professionals
from around the world including representatives of all the
major companies with active programmes in gene therapy.
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.
MetXia-P450
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, described at the conference,
the Company has shown that delivery of the human CYP2B6
gene to tumours, using MetXia-P450, does indeed increase
their sensitivity to cyclophosphamide and leads to enhanced
tumour cell killing. These data have provided the basis
of submissions to the regulatory authorities for trials
in breast cancer (BC1) and ovarian cancer (OC1). Initial
results for the BC1 trial are expected to be available towards
the end of the year, with OC1 results expected shortly afterwards.
Commenting
on the presentation Chief Executive, Alan Kingsman said,
"Oxford BioMedica's reputation for quality research is such
that it is often called upon to present details of its broad
technology base to prestigious meeting such as this. Presenting
our preclinical data allows us to showcase the broad platform
of technology that the Company has to offer to a wide audience
of professionals in industry and academia. Already we are
receiving enquiries from other technology-based as well
as large multinational pharmaceutical companies to explore
the application of our technology to their development programmes
in gene therapy. Some of these enquiries have already progressed
to the discussion of licensing terms between Oxford BioMedica
and the various commercial concerns".
"The
very high quality of the preclinical results that we have
presented today was crucial in supporting our submission
to GTAC for the approval of our clinical trial protocol
for the treatment of breast cancer. While we await the trial
results with eager anticipation, it must be remembered that
efficacy in pre-clinical studies does not guarantee efficacy
in man".
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Notes to Editors
1. Oxford BioMedica: Established in 1995, specialises
in the development and application of gene-based therapeutics
using advanced gene delivery technologies for the
treatment of disease in the areas of Oncology, Viral
Infection, Neurobiology, Cardiovascular Disease and
Genetic Deficiency. Oxford BioMedica plc was floated
on the UK Alternative Investment Market of the London
Stock Exchange in December 1996.
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