Oxford Biomedica PLC
20 February 2008
For Immediate Release 20 FEBRUARY 2008
OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO
CONTINUE TROVAX(R) PHASE III TRIST STUDY
ACHIEVEMENT TRIGGERS €10 MILLION MILESTONE PAYMENT FROM SANOFI-AVENTIS
Oxford, UK - 20 February 2008: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced today that the independent Data Safety Monitoring
Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has
completed its third planned interim analysis and recommended that the study
continue without modification. TroVax is Oxford BioMedica's novel cancer
immunotherapy product, which is being developed in collaboration with
sanofi-aventis. The continuation of the trial following this interim analysis
triggers a milestone payment to Oxford BioMedica of €10 million.
The role of the DSMB is to evaluate data from the ongoing trial to determine
whether there are safety issues or efficacy issues that would warrant
modification of the protocol or early termination of the study. The DSMB is
independent of Oxford BioMedica and sanofi-aventis and provides no information
beyond its recommendation.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax
in patients with locally advanced or metastatic clear cell renal carcinoma. The
trial is a randomised, placebo-controlled, two-arm study comparing TroVax in
combination with standard of care to placebo with standard of care. TRIST is
being conducted under a Special Protocol Assessment (SPA) agreement from the US
Food and Drug Administration (FDA) and was initiated in November 2006. To date,
over 600 patients have been randomised and more than 100 sites in the USA,
European Union and Eastern Europe are recruiting patients.
Professor Alan Kingsman, Chief Executive of Oxford BioMedica, said: 'The DSMB's
recommendation to continue the TRIST study is another important step in the
Phase III development of TroVax, which is recognised in our collaboration with
sanofi-aventis by a milestone payment. The trial is on track to complete patient
enrolment before the end of this quarter and we anticipate final results in
2009. In addition to further progress of the TRIST study in renal cancer, future
events will include sanofi-aventis commencing its planned Phase III trial of
TroVax in patients with metastatic colorectal cancer.'
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
JPMorgan Cazenove Limited:
James Mitford/ Gina Gibson Tel: +44 (0)20 7588 2828
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000
Buchanan Communications
Scientific/Trade Press Enquiries:
Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020
College Hill Life Sciences
US Enquiries:
Thomas Fechtner Tel: (646) 378 2900
The Trout Group LLC
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. The lead product candidate is TroVax(R),
an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis
for global development and commercialisation. TroVax is in Phase III
development. Oxford BioMedica has three other products in clinical development,
including ProSavin(R), 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(R)
TroVax is Oxford BioMedica's novel cancer immunotherapy product, 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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