Research Update
Oxford Biomedica PLC
10 July 2001
FOR IMMEDIATE RELEASE
2001/OB/14
10 July 2001
For further information, please contact:
Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive Tel: +44 (0) 1865 783 000
City/Financial Enquiries:
Melanie Toyne Sewell / Fiona Noblet
Financial Dynamics Tel: +44 (0) 207 831 3113
Scientific/Trade Press Enquiries:
Chris Gardner, HCC*De Facto Group Tel: +44 (0) 207 496 3300
GTAC Approval for Development of MetXia(R)
Clinical Programme
Oxford, UK - 10 July 2001: Oxford BioMedica plc announced today that it had
received approval from the UK's Gene Therapy Advisory Committee ('GTAC') for
the further development of the MetXia(R) clinical programme. The new trial,
designated BC2, will evolve from the current successful BC1 Phase I/II trial
in breast cancer patients. BC2 will use the MetXia(R) product made from an
enhanced manufacturing process.
In parallel with the current BC1 trial, BioMedica has been developing its
manufacturing technologies for gene therapy products. The primary goal of
these developments has been the configuration of a robust process that could
satisfy market demand should the product gain approval in the future. This has
now resulted in a process that can manufacture MetXia(R) at a 100-fold higher
efficiency than the prototype process used for BC1. The resultant product
delivered to the patients' tumour cells is the same, as is the mode of
delivery.
This new high efficiency process would be the one to be used in commercial
manufacture, therefore the Company has decided to accelerate the testing of
the product from this new process by the initiation of a new clinical trial
designated BC2 that is a development of the BC1 trial. Patients that would
have been recruited into the later stages of BC1 will now be recruited
directly into BC2.
Commenting on this news, Chief Executive Professor Alan Kingsman said:
'The new production method will make a significant difference in terms of the
commercial production of MetXia(R). However, because the product and the mode
of delivery are the same, there is no need to change the fundamental aspects
of the current protocol of the trial - BC1 will simply evolve into BC2. This
is yet another successful application to GTAC and we are pleased to see the
MetXia(R) programme developing in this way.'
Notes to Editors
1. Oxford BioMedica plc
Established in 1995, the Company specialises in the application of gene-based
technology to the development of novel therapeutics. Its three principal
activities are in the fields of gene therapy, immunotherapy and genomics, and
its principal therapeutic areas are in cancer and neurodegenerative diseases.
Oxford BioMedica plc was floated on the Alternative Investment Market of the
London Stock Exchange in December 1996, and upgraded to the United Kingdom
Listing Authority Official List in April 2001 following a successful £35.5
million fund-raising.
Currently Oxford BioMedica has corporate collaborations with Aventis,
AstraZeneca, IDM, Modex Therapeutics, Nycomed Amersham, Valentis, Virbac and
Wyeth. BioMedica has two products in Phase I/II clinical trials: MetXia(R) for
late-stage breast cancer and ovarian cancer, and TroVaxTM for late-stage
colorectal cancer.
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 and
ovarian cancer.
3. BC1 Clinical trial
The Phase I/II BC1 clinical trial of MetXia in patients with late-stage breast
cancer or melanoma, is being conducted at the Churchill hospital in Oxford.
The trial protocol called for the recruitment of up to 20 patients in two
groups. The initial part of the trial was designed to assess safety and to
establish that MetXia(R) results in transfer of the P450 gene to patients'
tumours. In November 2000 BioMedica reported results from the first part of
the trial, confirming that the primary goals of the trial, namely the
confirmation of safety and gene transfer, had been achieved.
4. 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 Control Agency (MCA). On approval by
the MCA, the products can be entered for clinical trials.
5. World Wide Web
This release is also available on the World Wide Web at http://
www.oxfordbiomedica.co.uk