8th Dec 2006 07:00
Oxford Biomedica PLC08 December 2006 For Immediate Release 8 DECEMBER 2006 OXFORD BIOMEDICA'S TROVAX(R)RECEIVES POSITIVE RECOMMENDATION FOR ORPHAN DRUG DESIGNATION IN RENAL CANCER FROM EMEA Oxford, UK - 8 December 2006: Oxford BioMedica (LSE: OXB), a leading genetherapy company, announced today that it has received positive opinion from theCommittee for Orphan Medicinal Products (COMP) recommending orphan drugdesignation for TroVax for the treatment of patients with renal cancer in theEuropean Union (EU). The COMP is part of the European Medicines Agency (EMEA).Final adoption of the opinion is expected from the European Commission in early2007. European orphan drug designation ensures a ten-year marketing exclusivity forTroVax within the EU. In addition, Oxford BioMedica and its prospective partnerwill benefit from a simplified, accelerated and cost-effective approvalprocedure under the consultative guidance of the EMEA. The Company plans torequest the equivalent orphan drug status in the USA. EU orphan drug designation was designed to encourage the development of productsthat demonstrate promise for the diagnosis, prevention and/or treatment oflife-threatening or very serious conditions that are rare and affect not morethan 5 in 10,000 persons in the EU. Renal cancer represents any malignant tumourwith its origin in the tissues of the kidneys. More than 150,000 people arenewly diagnosed with renal cancer worldwide each year. Prognosis is very poor.If renal cancer 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, renal canceraccounts for more than 33,000 deaths each year. Data from IMS suggest that over5,000 patients in the UK received treatment for metastatic renal cancer in 2005. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on thenews: "This positive recommendation from the EMEA for orphan drug designationadds further momentum to the development of TroVax. It underscores the need foreffective treatments for renal cancer, where treatment options are limited andthe prognosis is poor." Oxford BioMedica commenced a pivotal multi-centre Phase III trial of TroVax inrenal cancer in November 2006. The Phase III trial, denoted TRIST (TroVax RenalImmunotherapy Survival Trial), is designed to evaluate whether TroVaximmunotherapy, added to first-line standard of care therapy, prolongs thesurvival of patients with locally advanced or metastatic clear cell renalcarcinoma. Approximately 700 patients will be recruited from about 120 centresin the USA, EU and Eastern Europe. The primary endpoint for the trial issurvival improvement. Oxford BioMedica received a Special Protocol Assessmentagreement for the TRIST study from the US Food and Drug Administration (FDA).The trial is expected to reach a conclusion in 2008-09, which would support theCompany's objective of reaching product registration in 2009 in the USA and 2010in the EU. Oxford BioMedica has a key strategic objective of securing a major corporatepartner for the ongoing development and commercialisation of TroVax. The Companyhas progressed to negotiations of terms with its lead prospective partners andremains committed to finalising a deal expeditiously. -Ends- For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000 Professor Alan Kingsman, Chief ExecutiveCity/Financial Enquiries: Tel: +44 (0)20 7466 5000 Lisa Baderoon/ Mark Court/ Mary-Jane Johnson BuchananCommunicationsScientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555 Gemma Bradley/ Susan Yu/ Katja StoutNorthbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on oncology andneurotherapy. The Company was established in 1995 as a spin out from OxfordUniversity, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes two clinical candidates and a preclinical targeted antibody therapy,which is being developed in collaboration with Wyeth. The Company has startedPhase III development of its lead cancer immunotherapy product, TroVax, in renalcancer and multiple Phase II trials in various cancer settings are ongoing orplanned. In neurotherapy, the Company's lead product, ProSavin, is expected toenter clinical trials in Parkinson's disease in 2007. The preclinical pipelineincludes gene-based products for vision loss, motor neuron disease and nerverepair. 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 70 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica hascorporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed,Virxsys and Kiadis; and has licensed technology to a number of companiesincluding Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) TroVax is Oxford BioMedica's leading cancer immunotherapy product. It isdesigned specifically to stimulate an anti-cancer immune response and haspotential application in most solid tumour types. TroVax targets the tumourantigen 5T4, which is broadly distributed throughout a wide range of solidtumours. The presence of 5T4 is correlated with poor prognosis. The productconsists of a poxvirus (MVA) gene transfer system, which delivers the gene for5T4 and stimulates a patient's body to produce an anti-5T4 immune response. Thisimmune response destroys tumour cells carrying the 5T4. The Company is targetingcolorectal cancer and renal cell carcinoma as lead indications for thedevelopment of TroVax. Renal cell carcinoma is an indication where TroVax mightachieve a rapid route to product registration. Oxford BioMedica has started aPhase III trial (TRIST - TroVax Renal Immunotherapy Survival Trial) in 700patients with advanced renal cell carcinoma. The TRIST study received a SpecialProtocol Assessment from the US Food and Drug Administration in May 2006. APhase II trial in prostate cancer is ongoing and a trial in breast cancer is dueto start under the auspices of the US Southwest Oncology Group. To date, over 160 patients with colorectal, renal or prostate cancer(collectively over 550 doses) have been treated with TroVax. The product hasattracted support from Cancer Research UK, the US National Cancer Institute, andthe UK clinical trials network, QUASAR. These organisations are alreadyconducting or plan to conduct clinical trials with TroVax. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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