OXFORD
BIOMEDICA
Oxford Biomedica Announces First Clinical Trial Results
for its Cancer Therapeutic, MetXia®.
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®.
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® in a number ways, thereby broadening
the commercial potential of the product.
BioMedica's
MetXia® 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®.
Gene transfer was achieved in all patients and MetXia®
appeared to be safe and well tolerated throughout the dose
range.
MetXia®
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®
represents a platform technology for increasing tumour cell
death via the local activation of the prodrug, cyclophosphamide.
The Company has plans to develop MetXia® 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® is still
at an early stage in its clinical evaluation. There are some
very important results yet to be achieved before MetXia®
becomes a true success. However, the potential value of MetXia®
is high and we look forward to the next exciting stages of
the development of this product series". |
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| 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®
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
TroVaxT in colorectal cancer. The clinical programme
is expected to commence around the end of 2000.
|
| 2. |
MetXia®
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 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®, 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. |
|
| For
further information please contact: |
|
|
Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel:
+44 (0)1865 783 000 |
| City/Financial
Enquiries
David
Simonson, Melanie Toyne Sewell
Merlin Financial Communications |
Tel:
+44 (0)207 606 1244 |
| Scientific/Trade
Enquiries
Sue
Charles/ Chris
Gardner, HCC•De Facto Group |
Tel:
+44 (0)207 496 3300 |
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