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2004/OB/01
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Oxford
BioMedica Announces that Cancer Research UK has Received
Approval to Start a Phase II Trial with TroVax® in
Colorectal Cancer
Oxford
BioMedica announced today that Cancer Research UK (CR UK)
had received approval from the Gene Therapy Advisory Committee
(GTAC) to conduct a Phase II study of TroVax in colorectal
cancer patients who are to undergo surgery for resectable
liver metastases.
Twenty
Stage IV patients will receive injections of TroVax followed
by surgery approximately ten days 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 and they will be followed after the
final vaccination to assess immune responses and toxicity
and then monitored over the longer term for clinical benefit.
In August
2003, Oxford BioMedica announced that Cancer Research UK
had agreed to conduct and sponsor this open
label Phase
II trial. The decision by Cancer Research UK followed
extensive review of the successful Phase I/II data of TroVax
in colorectal
cancer patients.
Commenting
on the news Oxford BioMedica's Chief Executive,
Prof. Alan Kingsman said "This is the third
Phase II TroVax study that has been approved by GTAC
and we are delighted
to be working with Cancer Research UK in this important
aspect of colorectal cancer".
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ends -
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Return to the News
| Notes
| 1. |
Oxford
BioMedica plc |
| |
Oxford
BioMedica (LSE: OXB) is a biopharmaceutical
company specialising in the development
of gene-based products for a range of
unmet medical needs with an emphasis
on new cancer products, which combine
novel mechanisms of action with very
low side effects, and innovative neurotherapy
products, which address large and, in
several areas, untapped markets. The
products are all protected by multiple
patents comprising a total intellectual
property portfolio of some 69 patent
families, which represents one of the
broadest patent estates in the field.
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.
Oxford BioMedica has a wholly owned subsidiary
in San Diego, USA. Oxford BioMedica has
corporate collaborations with Wyeth, Intervet,
Amersham, Arius Research, Kiadis and Viragen.
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| 2. |
TroVax® cancer
immunotherapy |
 |
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 the UK in
Stage IV colorectal cancer patients receiving
5FU plus either oxaliplatin or irinotecan.
The product is also expected 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. The renal cancer trial in
the US is expected to start enrolment in
early 2004. Initial data from the first
TroVax Phase II trial in colorectal cancer
have confirmed the product’s safety
profile. Full results from the colorectal
cancer Phase II trials are anticipated
in 2004.
|
| 3. |
Cancer
Research UK |
| |
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. |
| |
| For
further information please contact:
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|
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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
|
| Scientific/Trade
Press Enquiries
Sue
Charles, Katja
Stout,
College Hill - Life Sciences |
Tel:
+44 (0)20 7886 8150 |
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