Response to Press Comment on FDA Ruling
Oxford Biomedica PLC
24 January 2000
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)171 606 1244
Scientific / Trade press Enquiries
Sue Charles / Sarah Pattinson, HCC De Facto Tel: +44 (0)171 496 3300
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 LentiVectorTM 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.'
Notes to Editors
1. 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.
2. 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.
3. Adenoviruses
Adenoviruses cause a common infection in man. Symptoms are usually those of a
severe cold.
4. Worldwide web
This release is also available on the Worldwide Web at
http://www.oxfordbiomedica.co.uk
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