RNS Number : 9707Y
Oxford Biomedica PLC
14 July 2008
FOR IMMEDIATE RELEASE 14 JULY 2008
Oxford BioMedica
OXFORD BIOMEDICA RECEIVES COMMITMENT FOR INDEPENDENT PHASE III TRIAL OF TROVAX® IN
ADJUVANT COLORECTAL CANCER
Oxford, UK - 14 July 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy company,
announced today that the Oncology Clinical
Trials Office (OCTO) remains committed to progress its Phase III trial of TroVax in adjuvant
colorectal cancer. The proposed trial, called
QUASAR V, is being coordinated by OCTO, which is part of the Clinical Pharmacology Department
of Oxford University. TroVax is Oxford
BioMedica's novel therapeutic cancer vaccine, which is being developed in collaboration with
sanofi-aventis.
OCTO issued its statement regarding the use of TroVax in the QUASAR V trial following the
recommendations of the Data Safety Monitoring
Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer, which was announced on
11 July. The statement was signed by Professor
David Kerr, Director of OCTO, and Dr Rachel Midgley, Clinical Director of OCTO. The statement
is as follows:
"Our understanding of the Data Safety Monitoring Board's recommendations issued in
relation to the TRIST study in renal cancer does not
impact on our enthusiasm to progress the QUASAR V TroVax study in adjuvant colorectal cancer.From both a scientific and clinical
perspective we feel that TroVax should be tested in the adjuvant setting of colorectal cancer
and remain committed to the study."
http://octo-oxford.org.uk/TroVax
QUASAR, which stands for QUick And Simple And Reliable, is a collaborative clinical trials
group focused on colorectal cancer. The
proposed QUASAR V study is a randomised, placebo-controlled Phase III trial of TroVax in
patients with Stage II/III colorectal cancer who
have had surgical resection of their primary tumours and been treated with adjuvant
chemotherapy. It is expected to enrol approximately
3,000 patients and has been designed with a primary endpoint of three-year disease-free
survival. The funding of QUASAR trials derives from
a variety of sources, including the UK Medical Research Council and the Department of Health.
Oxford BioMedica and its partner, sanofi-aventis, are reviewing the development plan for
TroVax, including the QUASAR V study and the
proposed Phase III trial in metastatic colorectal cancer.
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Mike McDonald, Chief Executive Officer Tel: +44 (0)1865 783 000
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Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in cancer
immunotherapy and gene-based therapies. The Company
was established in 1995, as a spin-out from Oxford University, and is listed on the London
Stock Exchange.
The Company has a platform of gene delivery technologies, which are based on highly
engineered viral systems. Oxford BioMedica also has
in-house clinical, regulatory and manufacturing know-how. TroVax® is the Company's
therapeutic vaccine, which is in clinical development for
multiple solid cancers. The product is licensed to sanofi-aventis for global development and
commercialisation. Oxford BioMedica has three
other products in clinical development, including ProSavin®, a novel gene-based treatment for
Parkinson's disease, in a Phase I/II trial.The Company is underpinned by over 80 patent families, which represent one of the broadest
patent estates in the field. The Company has a
staff of approximately 85. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth,
Sigma-Aldrich, MolMed and Virxsys. Technology
licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is
available at www.oxfordbiomedica.co.uk
2. TroVax®
TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, which is being developed in
collaboration with sanofi-aventis. 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 Modified Vaccinia Ankara vector, 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 antigen.
3. Oncology Clinical Trials Office
The Oncology Clinical Trials Office (OCTO) is concerned with the practical application of
high-quality clinical research into innovative
and effective cancer therapies particularly in the field of gastrointestinal cancer. OCTO's
key aims are to improve both survival rates and
the quality of life of cancer patients by contributing to the evidence-base that will underpin
cancer services now and in the future; and to
bring about major and continuing improvements in the quality of practice in clinical research.These aims will be achieved in partnership
with academic-led research communities, with industry and with patients and their carers. OCTO
is part of the Clinical Pharmacology
Department of Oxford University. Further information is available at
http://octo-oxford.org.uk/
This information is provided by RNS
The company news service from the London Stock Exchange
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