Notes
1. Oxford BioMedica, established in 1995, 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, neurobiology
and genetic deficiency. Oxford BioMedica plc was floated on
the UK Alternative Investment Market of the London Stock Exchange
in December 1996.
2. The Company intends to develop its candidate therapeutic
products and take them through their initial phases of clinical
testing. The candidate products are expected to be licensed
to suitable business partners who will then complete the later
phases of clinical trials, and ultimately manufacture and
market the products.
3. The Company also intends to exploit commercial opportunities
arising from its platform technologies with appropriate business
partners.
4. Oxford BioMedica was recently awarded a UK government
grant of £400,000 under the DTI SMART award scheme to support
the Company's first clinical trial programme.
5. This proposed clinical trial of MetXia-P450T will be
a Phase I/II trial in small numbers of late stage cancer patients
at one centre in the UK. As with all early stage clinical
trials, the aim of the trial is to gain safety data before
proceeding to larger scale trials. The design of the trial
also allows the Company to assess the best combination of
components in the product before embarking on later trials,
and may also provide data on efficacy. However, the small
number of patients in these trials means that results would
be unlikely to be statistically reliable.
6. The testing of alternative product configurations is
an important aspect which distinguishes gene therapy clinical
development from that of conventional single molecule drugs.
Oxford BioMedica would therefore expect its clinical programmes
to feature a small number of overlapping phase I/II trials
that will define the best combination of components in the
multi-component system before committing to a final product
specification for later trials.
7. The MetXia-P450T breast cancer trials will test the delivery
of the gene for a human cytochrome P450 enzyme which should
result in localised activation of the established anti-cancer
drug cyclophosphamide. Preclinical data show that this approach
greatly enhances the effectiveness of cyclophosphamide as
an anti-cancer agent. The approach should be applicable to
a range of solid tumour types and positive data from this
trial will facilitate the clinical development of other candidate
products for cancer.
