DSMB Interim Analysis-TroVax

Oxford Biomedica PLC 25 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 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 first scheduled interim analysis. The DSMB concluded that the trial should continue as planned without modifcation. The DSMB reviewed safety and anticancer immune responses from the first 50 patients enrolled. TroVax is Oxford BioMedica's novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. 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 is comprised of leading clinicians and biostatisticians with relevant expertise in the treatment of renal cancer and the conduct of clinical trials. 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. The standard of care therapies are interleukin-2, interferon-alpha or Sutent(R) (sunitinib). The protocol stratifies treatment between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced. The trial started in November 2006. To date, over 250 patients have been randomised of a target enrolment of approximately 700 patients. Approximately 100 sites of 150 identified centres in the USA, European Union and Eastern Europe are open for recruitment. The primary endpoint for the trial is survival improvement and secondary endpoints include progression-free survival, tumour response rates and quality of life scores. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA. The trial is expected to complete in early 2009. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the DSMB recommendation: 'We are pleased that the immunology data from this first analysis of the Phase III TRIST study meet the pre-set criteria for continuation. The safety profile remains encouraging. Recruitment into TRIST has been 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 783 000 Professor Alan Kingsman, Chief Executive City/Financial Enquiries: Tel: +44 (0)20 7466 5000 Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Scientific/Trade Press Enquiries: Tel: +44 (0)20 7268 3002 Gemma Price/ Holly Griffiths/ Katja Stout Northbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development and commercialisation of novel therapeutic vaccines and gene-based therapies with a focus on oncology and neurotherapy. 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. In oncology, the lead product candidate is TroVax(R), an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. A Phase III trial of TroVax in renal cancer is ongoing and sanofi-aventis is implementing a development plan for colorectal cancer. Oxford BioMedica's oncology pipeline includes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, which has completed two clinical trials. In neurotherapy, the Company's lead product, ProSavin(R), is expected to enter clinical development for Parkinson's disease in 2007. The neurotherapy pipeline also includes preclinical gene-based therapeutics for vision loss, motor neuron disease and nerve repair. 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 80 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners include 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 and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) TroVax is Oxford BioMedica's leading 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 poxvirus (MVA) gene transfer system, 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. In 2006, Oxford BioMedica started a Phase III trial of TroVax in renal cancer and sanofi-aventis is implementing a development plan for colorectal cancer. The product has attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR. These organisations are conducting 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 of first diagnosis, the five-year survival rate is less than 5%. In the USA and Europe, RCC accounts for more than 33,000 deaths each year. Data from IMS suggest that over 5,000 patients in the UK received treatment for metastatic RCC in 2005. This information is provided by RNS The company news service from the London Stock Exchange
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