OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING
BOARD RECOMMENDATION TO CONTINUE TROVAX PHASE III TRIST STUDY OF TROVAX
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 Buchanan Communications
Tel: +44 (0)20 7466 5000
Scientific/Trade Press Enquiries:
Gemma Price/ Holly Griffiths/ Katja Stout
College Hill Life Sciences
Tel: +44 (0)20 7457 2020
US Enquiries:
Thomas Fechtner
The Trout Group LLC
Tel: (646) 378 2900
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®,
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®, 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 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.