Oxford Biomedica Regulatory News (OXB)

10 Mar 2008 07:02

Oxford Biomedica PLC10 March 2008 Simultaneously to the analyst briefing at 10:30am, there will be a live audioweb cast of the results presentation. To connect to the web cast facility,please go to http://mediaserve.buchanan.uk.com/webcasts/livegold/lrframes.htmapproximately 10 minutes (10:20am) before the start of the briefing. In additionto the web cast there will also be a conference call which will include a Q andA session please dial +44 (0)20 8609 1435 and use pin number 131567# For Immediate Release 10 MARCH 2008 OXFORD BIOMEDICA COMPLETES PATIENT RECRUITMENT FOR PHASE III TRIST STUDY OF TROVAX(R) IN RENAL CANCER Oxford, UK - 10 March 2008: Oxford BioMedica (LSE: OXB), a leading gene therapycompany, announced today that it has successfully completed patient enrolment inthe Phase III TRIST study of TroVax in renal cancer. TroVax is OxfordBioMedica's novel cancer immunotherapy product, which is being developed incollaboration with sanofi-aventis. Over 690 patients have been randomisedto-date and a sufficient number of additional patients are being screened forinclusion such that the total enrolment is expected to slightly exceed thetarget of 700 patients. Over 100 sites in the USA, European Union and EasternEurope have recruited patients into the trial. The trial started in November2006, recruitment has been completed on schedule and final results from thestudy are anticipated in the first half of 2009. 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. It is beingconducted under a Special Protocol Assessment (SPA) agreement from the US Foodand Drug Administration (FDA). Oxford BioMedica recently announced that theindependent Data Safety Monitoring Board (DSMB) for the TRIST study completedits third planned interim analysis and recommended that the study continuewithout modification. Dr Mike McDonald, Chief Medical Officer of Oxford BioMedica, said: "Completingrecruitment so rapidly in such a large Phase III trial is a significantachievement for us. We are extremely grateful to the clinicians for theirsupport and, of course, the patients with renal cancer that are participating inthe TRIST study. The trial is on track to reach its final analysis in the firsthalf of 2009. We, together with our partner sanofi-aventis believe that TroVaxcould provide an important treatment option for patients with renal cancer aswell as potentially other common types of cancer. We are delighted that, withinthe next few months, sanofi-aventis will broaden the development programme forTroVax with the start of the first Phase III trial of TroVax in colorectalcancer." -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 5000Buchanan Communications Scientific/Trade Press Enquiries:Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020College Hill Life Sciences US Enquiries:Thomas Fechtner Tel: (646) 378 2900The 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. 3. Phase III TRIST study 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. Recruitmentof approximately 700 patients is complete at over 100 sites in the USA, EuropeanUnion and Eastern Europe. TRIST is being conducted under a Special ProtocolAssessment (SPA) agreement from the US Food and Drug Administration (FDA). This information is provided by RNS The company news service from the London Stock Exchange