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2003/OB/15
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Cancer Research
UK Supports Additional TroVax Phase II Trial in Colorectal
Cancer
Oxford
BioMedica announced today that Cancer Research UK has agreed
to conduct and sponsor an open label Phase II trial with Oxford
BioMedica’s leading cancer immunotherapy product, TroVax®,
in colorectal cancer patients who have liver metastases. The
decision by Cancer Research UK follows extensive review of
the successful Phase I/II data of TroVax in colorectal cancer
patients. This study is in addition to the two ongoing Phase
II trials with TroVax in colorectal cancer alongside chemotherapy,
and the planned trials in renal and breast cancer.
The patient
population in the Cancer Research UK Phase II trial will comprise 20 Stage
IV colorectal cancer patients who are to undergo surgery for
resectable liver metastases. Patients will receive injections
of TroVax followed by surgery approximately two weeks later.
Biopsies of the tumour will be taken at surgery and analysed
for TroVax stimulated immune activity. Further vaccinations
will be given after surgery. Patients’ management will
then continue as standard, usually including adjuvant chemotherapy.
Patients will be followed after the final vaccination to assess
immune responses and toxicity and then monitored over the
longer term for clinical benefit.
Commenting on the announcement, Oxford BioMedica’s Chief
Executive, Professor Alan Kingsman said, “Cancer
Research UK is one of the world’s leading cancer research
organisations and is committed to the development of better
cancer treatments for patients. Their involvement in this
project provides further validation of Oxford BioMedica’s
advanced cancer immunotherapeutic”
-Ends-
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| Notes
| 1. |
Oxford
BioMedica |
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Based
in Oxford, UK, Oxford BioMedica is a biopharmaceutical
company specialising in the development of novel gene-based
therapeutics for the treatment of cancer, neuro-degenerative
disease and other disorders with major unmet clinical
needs. The Company was established in 1995 as a spin
out from Oxford University, and is listed on the London
Stock Exchange.
In
addition to its technical research skill-base, Oxford
BioMedica has in-house clinical, regulatory and manufacturing
know-how. The development pipeline includes two novel
anti-cancer products in clinical trials and a gene-based
treatment for Parkinson’s disease, which is in
late preclinical studies. The Company is underpinned
by an extensive preclinical and research portfolio and
over 70 patent families, about quarter of which are
issued.
TroVax®,
which is Oxford BioMedica’s lead cancer immunotherapy
product, is in Phase II trials for colorectal cancer
(see below). MetXia®
is Oxford BioMedica’s lead gene-based cancer therapeutic.
The product is based on a highly engineered retrovirus
gene delivery system expressing a specific human cytochrome
P450 gene. MetXia converts the tumour into a ‘drug
factory’, enabling increased local production
of the anti-tumour, cytotoxic derivative of the pro-drug
cyclophosphamide. MetXia is potentially useful in the
treatment of all solid tumours and their metastases,
particularly those where cyclophosphamide is commonly
used. MetXia is being investigated in a Phase I/II trial
in breast cancer, and regulatory submissions are under
review for trials in pancreactic cancer.
Oxford
BioMedica has a wholly-owned subsidiary in San Diego,
USA. Oxford BioMedica has corporate collaborations with
Wyeth, Intervet, Aliga Pharmaceuticals, Amersham, Arius
Research and Viragen. |
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| 2. |
TroVax |
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TroVax is Oxford BioMedica’s leading cancer immunotherapy
product. It is designed specifically to stimulate an
anti-cancer immune response and has potential application
in most solid tumour types. TroVax targets the tumour
antigen 5T4, which is broadly distributed throughout
a wide range of solid tumours. The presence of 5T4 is
correlated with poor prognosis. The product consists
of a poxvirus (MVA) gene transfer system, which delivers
the gene for 5T4 and stimulates a patient’s body
to produce an anti-5T4 immune response. This immune
response destroys tumour cells carrying the 5T4 protein.
Two
Phase I/II trials with TroVax have been completed in
the UK in late-stage colorectal cancer patients. Following
these successful Phase I/II trials, TroVax has entered
two Phase II trials in Stage IV colorectal cancer patients
receiving 5FU plus either oxaliplatin or irinotecan.
The product is also on target to enter further trials
in colorectal, renal and breast cancer. The renal and
breast cancer trials are to be conducted in the United
States under an Investigational New Drug (IND) application.
Data from the first TroVax Phase II trial is expected
to be available by the end of 2003, in readiness for
Phase III trials in colorectal cancer. |
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| 3. |
Cancer
Research UK |
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Cancer Research UK began operating on 4 February 2002
as a result of the merger between The Cancer Research
Campaign and Imperial Cancer Research Fund. Its vision
is to conquer cancer through world-class research. It
is the largest volunteer-supported cancer research organisation
in the world with a dedicated team of 3,000 scientists
and an annual scientific spend of more than £176
million. Its objectives, amongst others, are to: carry
out world class research into cancer; develop better
treatments for cancer patients; improve the quality
of life of cancer patients; reduce the number of people
getting cancer; improve training and support of cancer
research workers; and provide authoritative information
and advocacy on cancer.
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| For
further information please contact: |
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel: +44 (0)1865 783 000 |
| City/Financial
Enquiries
Mike
Wort/James Chandler
Beattie Financial |
Tel: +44 (0)20 7398 3300
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| Scientific/Trade
Enquiries
Sue
Charles, Katja
Stout,
College Hill - Life Sciences |
Tel:
+44 (0)20 7886 8150 |
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