Oxford Biomedica Regulatory News (OXB)

25 Jul 2007 07:00

Oxford Biomedica PLC25 July 2007 For Immediate Release 25 JULY 2007 OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO CONTINUE TROVAX(R) PHASE III TRIAL IN RENAL CANCER AS PLANNED Oxford, UK: 25 July 2007: Oxford BioMedica (LSE: OXB), a leading gene therapycompany, announced today that the independent Data Safety Monitoring Board(DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed itsfirst scheduled interim analysis. The DSMB concluded that the trial shouldcontinue as planned without modifcation. The DSMB reviewed safety and anticancerimmune responses from the first 50 patients enrolled. TroVax is OxfordBioMedica's novel cancer immunotherapy product, which is being developed incollaboration with sanofi-aventis. 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 is comprised of leadingclinicians and biostatisticians with relevant expertise in the treatment ofrenal cancer and the conduct of clinical trials. 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. The standardof care therapies are interleukin-2, interferon-alpha or Sutent(R) (sunitinib).The protocol stratifies treatment between the standard of care options to ensurethat the allocation of TroVax and placebo is rigorously balanced. The trial started in November 2006. To date, over 250 patients have beenrandomised of a target enrolment of approximately 700 patients. Approximately100 sites of 150 identified centres in the USA, European Union and EasternEurope are open for recruitment. The primary endpoint for the trial is survivalimprovement and secondary endpoints include progression-free survival, tumourresponse rates and quality of life scores. The trial is being conducted under aSpecial Protocol Assessment (SPA) agreement from the US Food and DrugAdministration (FDA). The SPA agreement ensures that the design, conduct,analysis and endpoints of the trial are all acceptable to the FDA. The trial isexpected to complete in early 2009. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on theDSMB recommendation: "We are pleased that the immunology data from this firstanalysis of the Phase III TRIST study meet the pre-set criteria forcontinuation. The safety profile remains encouraging. Recruitment into TRIST hasbeen rapid and we are on track to complete patient enrolment during Q1 2008." -Ends- For further information, please contact: Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor Alan Kingsman, Chief Executive City/Financial Enquiries: Tel: +44 (0)20 7466 5000Lisa Baderoon/ Mark Court/ Mary-Jane Johnson BuchananCommunications Scientific/Trade Press Enquiries: Tel: +44 (0)20 7268 3002Gemma Price/ Holly Griffiths/ Katja StoutNorthbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment and commercialisation of novel therapeutic vaccines and gene-basedtherapies with a focus on oncology and neurotherapy. The Company was establishedin 1995 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. In oncology, the lead product candidateis TroVax(R), an immunotherapy for multiple solid cancers, which is licensed tosanofi-aventis for global development and commercialisation. A Phase III trialof TroVax in renal cancer is ongoing and sanofi-aventis is implementing adevelopment plan for colorectal cancer. Oxford BioMedica's oncology pipelineincludes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, whichhas completed two clinical trials. In neurotherapy, the Company's lead product,ProSavin(R), is expected to enter clinical development for Parkinson's diseasein 2007. The neurotherapy pipeline also includes preclinical gene-basedtherapeutics for vision loss, motor neuron disease and nerve repair. The Company is underpinned by over 80 patent families, which represent one ofthe broadest patent estates in the field. The Company has a staff ofapproximately 80 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Corporate partnersinclude sanofi-aventis for TroVax and Wyeth for the targeted antibody therapy.The Company also has collaborations with Sigma-Aldrich, MolMed and Virxsys.Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline andPfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) TroVax is Oxford BioMedica's leading cancer immunotherapy product, which isbeing developed in collaboration with sanofi-aventis. It is designedspecifically to stimulate an anti-cancer immune response and has potentialapplication in most solid tumour types. TroVax targets the tumour antigen 5T4,which is broadly distributed throughout a wide range of solid tumours. Thepresence of 5T4 is correlated with poor prognosis. The product consists of apoxvirus (MVA) gene transfer system, which delivers the gene for 5T4 andstimulates a patient's body to produce an anti-5T4 immune response. This immuneresponse destroys tumour cells carrying the 5T4. In 2006, Oxford BioMedica started a Phase III trial of TroVax in renal cancerand sanofi-aventis is implementing a development plan for colorectal cancer. Theproduct has attracted support from Cancer Research UK, the US National CancerInstitute, and the UK clinical trials network, QUASAR. These organisations areconducting or plan to conduct clinical trials with TroVax. 3. Renal cancer Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA.More than 150,000 people are newly diagnosed with RCC worldwide each year.Prognosis is very poor. If RCC has metastasised to other organs at the time offirst diagnosis, the five-year survival rate is less than 5%. In the USA andEurope, RCC accounts for more than 33,000 deaths each year. Data from IMSsuggest that over 5,000 patients in the UK received treatment for metastatic RCCin 2005. This information is provided by RNS The company news service from the London Stock Exchange