Oxford Biomedica PLC
16 January 2004
16 January 2004
OXFORD BIOMEDICA ANNOUNCES THAT CANCER RESEARCH UK HAS RECEIVED APPROVAL TO
START A PHASE II TRIAL WITH TROVAX(R) IN COLORECTAL CANCER
Oxford, UK: 16 January 2004 - 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'.
-Ends-
For further information, please contact:
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: Northbank Communications Tel: +44 (0)20 7886 8150
Notes to editors
1. Oxford BioMedica
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.
Further information is available at http://www.oxfordbiomedica.co.uk
2. TroVax(R) 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.
This information is provided by RNS
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