OXFORD BIOMEDICA
Oxford Biomedica Commences
Clinical Trial of TroVax
Oxford, UK -2
January 2001: Oxford BioMedica ("BioMedica") announced today that
the Medicines Control Agency (the 'MCA'), the division of the National
Health Service which regulates the safety, quality and efficacy
of all medicines in the UK market, has approved BioMedica's cancer
vaccine, TroVaxT for a Phase I/II clinical trial in patients with
colorectal cancer.
TroVaxT is a
gene-based therapeutic vaccine that is designed to stimulate the
patient's immune system to mount a powerful anti-cancer response.
The immune system plays a key role in fighting infections and disease.
However with cancer, the patient's immune system often fails to
react to the existence of a tumour and as a result an immune response
is not triggered. TroVax is designed to stimulate a patient's
immune system to recognise and destroy cancer cells in this situation.
The product
is based on a gene that encodes a protein that exists only on the
surface of tumour cells and not on normal cells - such proteins
are known as Tumour Associated Antigens (TAAs). When this gene is
expressed by Oxford BioMedica's highly engineered virus-based delivery
system, it induces a potent anti-tumour response. This means that
cells and antibodies of the immune system seek out tumour cells
carrying the TAA and destroy them. In preclinical model systems
the results have been very striking, with TroVaxT breaking immune
tolerance to tumours and protecting against further tumour growth.
TroVaxT will be trialled on patients with late stage colorectal
cancer, at the Christie Hospital, Manchester, one of the UK's leading
cancer centres.
BioMedica is
already in Phase I/II clinical trials with MetXiaŽ, its first anti-cancer
gene therapy product. During 2000, the Company also completed two
collaborative agreements based on TroVaxT and its related technology.
In the first collaboration, a veterinary version of TroVaxT was
licensed to the major European veterinary company, Virbac SA for
development to treat cancer in 'companion' animals e.g. dogs. The
second agreement was with Nycomed Amersham to develop a tumour imaging
agent based on a proprietary antibody to the TAA targeted by TroVaxT.
Commenting on
the announcement, Professor Alan Kingsman, Chief Executive of Oxford
BioMedica, said:
"This is a very significant development. Already TroVaxT and
its related technology have attracted substantial commercial interest
and are the subject of 2 important collaborations. The strength
of our preclinical results together with the potentially broad applicability
of TroVaxT to treat a wide range of cancers make this a leading
product in BioMedica's portfolio, either for use on its own as a
cancer vaccine or in conjunction with other treatments. However,
we should recognise that our successes to date have been in model
systems for cancer and while these results were the best we could
have hoped for, the evaluation of TroVaxT in clinical trials will
be key to determining the future for this product."
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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 and immunotherapeutics
for the treatment of disease in the areas of Oncology, Neurobiology
and Viral Infection and in Gene Discovery. Oxford BioMedica plc
was floated on the Alternative Investment Market of the London
Stock Exchange in December 1996.
Currently
Oxford BioMedica has corporate collaborations with Aventis, AstraZeneca,
IDM, Modex Therapeutics, Nycomed Amersham, Valentis and Virbac.
BioMedica's first clinical product, MetXiaŽ is in Phase I/II clinical
trials for late-stage breast cancer (BC1) and ovarian cancer (OC1).
TroVaxT is the Company's second product in clinical trials.
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