OXFORD
BIOMEDICA PLC
GTAC APPROVAL FOR DEVELOPMENT OF METXIA®
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® 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® 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® 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®.
However, because the product and the mode of delivery is 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® programme
developing in this way."
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| 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®
for late-stage breast cancer (BC1) and ovarian cancer
(OC1), and TroVax™ for late-stage colorectal cancer.
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| 2. |
MetXia®
gene therapy for cancer
In gene therapy, the aim is to deliver a gene and its
necessary regulatory elements (the gene construct) to
the cell surface, using a vector to mediate the transfer
across the cell membrane and, in some cases, into the
nucleus. A new and increasingly powerful vector system
is based on lentiviruses, which have similar features
to retroviruses in the ease of manipulation, predictable
integration and reliable gene expression and regulation.
However, their main advantage over retroviruses is the
ability to function in non-dividing cells or cells that
are dividing slowly - a feature of many clinically important
tissues including the central and peripheral nervous system.
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| 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®
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.
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| 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.
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| For
further information please contact: |
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|
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)20 7496 3300 |
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