OXFORD
BIOMEDICA
ANNOUNCES DETAILS OF ITS FIRST CLINICAL
TRIAL IN CANCER
Breast Cancer to be Targeted
with Novel Gene Therapy
Oxford BioMedica plc has announced
today the details of its first clinical trial now planned
to begin at the end of 1998, a year ahead of schedule.
The trial will evaluate the
safety and preliminary efficacy of a novel gene therapy for
breast cancer. It will involve injecting a retroviral vector
carrying two genes directly into tumour nodules in late stage
breast cancer patients. This will allow a number of entirely
new approaches for managing cancer to be assessed. The outcome
of the trial is set to have an impact on the treatment of
a wide range of solid tumours.
Commenting on the news, Andrew
Wood, Finance Director, said: "This rapid progress is a function
of dedicated in-house research and development activities
and the in-licensing of key technology. If successful these
proposed trials could bring forward the time when the Company
earns revenues."
A maximum of 20 patients will
be involved and recruitment will begin in the fourth quarter
of 1998. It is expected that the trial will be conducted at
the Institute of Molecular Medicine in Oxford and initial
results should be available mid 1999.
The primary aim of the trial
will be to determine the effectiveness of the Company's proprietary
genetic switch, the Hypoxia Response Element (HRE). This will
be achieved by linking a biochemical marker gene to this switch
and determining whether hypoxia control is effective in the
human tumour. In model systems this switch is only activated
in tumour cells and it is designed to ensure that the therapy
is active just where it is needed. This is expected to reduce
the often severe side effects observed with current anti-cancer
therapies. The quantitative readout from this part of the
trial, if successful, will enable the Company to accelerate
the use of this technology in other solid tumour applications.
In addition, the Company intends
to include one of its proprietary therapeutic genes in the
trial. The therapeutic gene has been designed to specifically
kill tumour cells and the effect is expected to be amplified
in the tumour to ensure maximum cell destruction.
"We are very pleased to announce
Oxford BioMedica's first clinical trial which will take place
a full year ahead of schedule. This acceleration substantiates
the Group's commitment to cancer therapy through the development
of innovative strategies and collaborative in-licensing activities.
This significant progress positions Oxford BioMedica's proprietary
gene therapy technology as a competitive force in the field,"
stated Professor Alan Kingsman, Chief Executive.
Notes to Editors:
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. Many current anti-cancer treatments are based on the (incorrect)
assumption that a tumour is a uniform mass of rapidly dividing
cells, each identical in all respects. In fact it has been
demonstrated that 'micro-environments' exist within solid
tumour masses where, in particular, oxygen levels are deficient,
leading to a condition known as hypoxia. Hypoxia is rare in
normal tissues but a common feature of all solid tumours.
The Hypoxia Response Element (HRE) activates the production
of anti-cancer therapeutics in hypoxic conditions.
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