Oxford Biomedica Regulatory News (OXB)

10 Dec 2007 07:00

Oxford Biomedica PLC10 December 2007 For immediate release 10 December 2007 OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION TO CONTINUE TROVAX(R) PHASE III TRIAL IN RENAL CANCER Oxford, UK: 10 December 2007: 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 second planned interim analysis. The DSMB concluded that the trialshould continue as planned without modification. TroVax is Oxford BioMedica'snovel cancer immunotherapy product, which is being developed in collaborationwith 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, more than 500 patients have beenrandomised of a target enrolment of approximately 700 patients. Over 100 sitesin the USA, European Union and Eastern Europe are recruiting patients. Theprimary endpoint for the trial is overall survival in the TroVax-treated groupversus the placebo group. Secondary endpoints include progression-free survivalat 26 weeks, tumour response rates and quality of life scores. The trial isbeing conducted under a Special Protocol Assessment (SPA) agreement from the USFood and Drug Administration (FDA). The SPA agreement ensures that the design,conduct, analysis and endpoints of the trial are all acceptable to the FDA. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on theDSMB recommendation: "This interim analysis by the DSMB is an important step inthe progress of the TRIST study. It is the first analysis that compares thesafety and efficacy of the TroVax and placebo arms of the study. We aredelighted by the positive recommendation. We remain on track to complete patientenrolment during Q1 2008 and we anticipate final results in 2009." -Ends- For further information, please contact: Oxford BioMedica plc:Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000JPMorgan Cazenove LimitedJames Mitford/Gina Gibson Tel: +44 (0)20 7588 2828City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Tel: +44 (0)20 7466 5000CommunicationsScientific/Trade Press Enquiries:Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020College Hill Life SciencesUS 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 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 two Phase III trials in colorectalcancer are planned. Oxford BioMedica has two other anti-cancer productcandidates in Phase II development for melanoma and pancreatic cancerrespectively. In neurotherapy, the Company has submitted a Clinical TrialApplication to start a Phase I/II trial of its gene-based treatment forParkinson's disease, ProSavin(R). The neurotherapy pipeline also includespreclinical gene-based therapeutics for vision loss, motor neuron disease andnerve 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 an anti-cancer targeted antibodytherapy. The Company also has collaborations with Sigma-Aldrich, MolMed andVirxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKlineand Pfizer. 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. Oxford BioMedica and Sanofi-aventis entered a global development andcommercialisation agreement for TroVax in March 2007. The companies areco-funding a Phase III trial of TroVax in renal cancer and sanofi-aventis isimplementing a Phase III development plan for colorectal cancer. The product hasalso attracted support from Cancer Research UK, the US National CancerInstitute, and the UK clinical trials network, QUASAR. 3. Phase III TRIST study The Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study commencedin November 2006 in patients with locally advanced or metastatic clear cellrenal carcinoma. The trial is a randomised, placebo-controlled, two-arm studycomparing TroVax in combination with standard of care to placebo with standardof care. The standard of care therapies are Sutent(R) (sunitinib),interferon-alpha or interleukin-2. The trial is being conducted at centres inthe USA, European Union and Eastern Europe. The primary endpoint for the trialis survival improvement. The trial, which commenced enrolment in November 2006,is being conducted under a Special Protocol Assessment (SPA) agreement from theUS Food and Drug Administration (FDA). The trial is expected to complete in2009. For more information on the ongoing Phase III TRIST study of TroVax visit:www.trovax.co.uk 4. Renal cancer Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA,accounting for nine out of ten cases of the disease. More than 150,000 peopleare newly diagnosed with RCC worldwide each year. Prognosis is very poor. If RCChas metastasised to other organs at the time of first diagnosis, the five-yearsurvival rate is less than 5%. In the USA and Europe, RCC accounts for more than33,000 deaths each year. Treatment options for patients with kidney cancer arelimited. Surgical removal of the tumour tends only to be successful inearly-stage disease. As the disease progresses, there are several commonly usedtherapies including immunostimulatory cytokines and kinase inhibitors. This information is provided by RNS The company news service from the London Stock Exchange