OXFORD BIOMEDICA
Response to Press Commentary on FDA Ruling
on Philadelphia Gene Therapy Trials
Following recent
press coverage regarding the University of Pennsylvania's adenoviral
gene therapy trial, the Directors of Oxford BioMedica would like
to clarify that the Company does not have any clinical programmes
that involve administration of adenoviral vectors to patients.
Oxford BioMedica
has developed a range of vectors to deliver therapeutic genes into
patients' cells, which have been specifically selected for their
safety and efficacy. Unlike some other gene therapy companies and
academic research groups BioMedica has focused on developing gene
transfer vectors from viruses that do not cause diseases in man,
and which have been engineered so that there is no possibility of
toxic viral proteins being made in the body. The most notable of
these is BioMedica's proprietary LentiVector system, which
is based on the horse virus, equine infectious anaemia virus (EIAV),
with which the Company has recently reported enhanced gene delivery
to tumours in vivo.
The Company
currently has its cancer product, MetXia-P450, undergoing clinical
trials and other products going through the pre-clinical regulatory
process. In all cases the Company's procedures for clinical trials
conform to the stringent criteria of the Gene Therapy Advisory Committee
(GTAC) and the Medicines Control Agency (MCA) of the United Kingdom
and they represent some of the most rigorous gene therapy research
protocols worldwide. The trials are also managed by and report to
an independent clinical trial organisation.
Alan Kingsman,
Chief Executive of Oxford BioMedica plc, said:
"One of
the technical concerns over the use of adenoviral vectors has been
that we all have adenovirus infections during our lives. As a result
of these infections our immune systems are primed to react against
this virus or gene delivery vectors derived from it. A strong immune
reaction to a high dose of vector can trigger adverse effects in
patients and this may have been what happened in the University
of Pennsylvania case. It is, in part, for this reason that Oxford
BioMedica does not use adenoviral vectors for direct administration
to patients and has instead developed vectors from viruses that
do not infect man."
"We see no
reason why our product development programmes should be affected
by these unfortunate events. The UK's overseeing body, the Gene
Therapy Advisory Committee, is not making any changes to any trials
and our trials are progressing on course. It is conceivable that
some gene therapy companies in the USA, that use adenoviral vectors,
may have trials delayed by the FDA while protocols are reviewed
but that should not affect Oxford BioMedica's programmes."
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Notes
to Editors
- Oxford
BioMedica plc
Established in 1995, the Company 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 and neurodegenerative disease. Oxford
BioMedica plc was floated on the UK Alternative Investment Market
of the London Stock Exchange in December 1996.
- Lentivirus
vector systems
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 potentially very
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. In addition
they show no detectable adverse inflammatory responses. 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.
- Adenoviruses
Adenoviruses cause a common infection in man. Symptoms are usually
those of a severe cold.
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
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+44 (0)1865 783000 |
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