Oxford Biomedica Regulatory News (OXB)

20 Feb 2008 07:00

Oxford Biomedica PLC20 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 genetherapy company, announced today that the independent Data Safety MonitoringBoard (DSMB) for the Phase III TRIST study of TroVax in renal cancer hascompleted its third planned interim analysis and recommended that the studycontinue without modification. TroVax is Oxford BioMedica's novel cancerimmunotherapy product, which is being developed in collaboration withsanofi-aventis. The continuation of the trial following this interim analysistriggers a milestone payment to Oxford BioMedica of €10 million. The role of the DSMB is to evaluate data from the ongoing trial to determinewhether there are safety issues or efficacy issues that would warrantmodification of the protocol or early termination of the study. The DSMB isindependent of Oxford BioMedica and sanofi-aventis and provides no informationbeyond its recommendation. TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVaxin patients with locally advanced or metastatic clear cell renal carcinoma. Thetrial is a randomised, placebo-controlled, two-arm study comparing TroVax incombination with standard of care to placebo with standard of care. TRIST isbeing conducted under a Special Protocol Assessment (SPA) agreement from the USFood 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'srecommendation to continue the TRIST study is another important step in thePhase III development of TroVax, which is recognised in our collaboration withsanofi-aventis by a milestone payment. The trial is on track to complete patientenrolment before the end of this quarter and we anticipate final results in2009. In addition to further progress of the TRIST study in renal cancer, futureevents will include sanofi-aventis commencing its planned Phase III trial ofTroVax 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 000JPMorgan Cazenove Limited: James Mitford/ Gina Gibson Tel: +44 (0)20 7588 2828City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000Buchanan CommunicationsScientific/Trade Press Enquiries: Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020 College Hill Life SciencesUS 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 incancer immunotherapy and gene-based therapies. The Company was established in1995, as a spin-out from Oxford University, and is listed on the London StockExchange. The Company has a platform of gene delivery technologies, which are based onhighly 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-aventisfor global development and commercialisation. TroVax is in Phase IIIdevelopment. Oxford BioMedica has three other products in clinical development,including ProSavin(R), a novel gene-based treatment for Parkinson's disease, ina Phase I/II trial. The Company is underpinned by over 80 patent families, whichrepresent one of the broadest patent estates in the field. The Company has astaff of approximately 85. Oxford BioMedica has collaborations withsanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licenseesinclude 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 beingdeveloped in collaboration with sanofi-aventis. It is designed specifically tostimulate an anti-cancer immune response and has potential application in mostsolid tumour types. TroVax targets the tumour antigen 5T4, which is broadlydistributed throughout a wide range of solid tumours. The presence of 5T4 iscorrelated with poor prognosis. The product consists of a Modified VacciniaAnkara vector, which delivers the gene for 5T4 and stimulates a patient's bodyto produce an anti-5T4 immune response. This immune response destroys tumourcells carrying the 5T4. This information is provided by RNS The company news service from the London Stock Exchange