Oxford Biomedica Regulatory News (OXB)

6 Oct 2006 07:01

Oxford Biomedica PLC06 October 2006 For immediate release 6 OCTOBER 2006 Oxford BioMedica OXFORD BIOMEDICA PRESENTS ENCOURAGING IMMUNOLOGICAL DATA FROM SIX PHASE II TRIALS OF TROVAX(R) IN VARIOUS CANCERS - TroVax induces significant anti-cancer immune responses - Oxford, UK - 6 October 2006: Oxford BioMedica (LSE: OXB), a leading gene therapycompany, announced today that it has presented further encouraging data from sixPhase II trials of TroVax, its lead cancer immunotherapy product, at the 14thInternational Cancer Immunotherapy Meeting, which is sponsored by the CancerResearch Institute and the Academy of Cancer Immunology and is being held from4-6 October 2006, in New York City. http://www.cancerresearch.org/cancerimmunotherapy2006/index.html The presentation comprised an analysis of immune responses induced against the5T4 tumour antigen by TroVax in 63 patients. In addition to immunological datafrom two completed Phase II trials of TroVax with standard chemotherapy incolorectal cancer, the analysis included new data from four ongoing Phase IItrials of TroVax alongside standard therapies in renal cancer and prostatecancer. The results showed that 84% of patients had 5T4-specific antibodyresponses after three injections of TroVax. 5T4-specific cellular responses wereevident in 87% of patients in the two trials in colorectal cancer, andpreliminary analyses also show cellular responses in the renal cancer andprostate cancer trials. These data demonstrate that TroVax can be administeredboth safely and also without loss of immunological efficacy in these three typesof cancer alongside numerous co-medications. Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on theimmunological analysis: "Stimulating a significant and sustainable anti-cancerimmune response has been a challenge for the field of cancer immunotherapy.TroVax has been shown to induce consistently strong immune responses in multiplecancer settings even when administered alongside other therapies. These dataconfirm the breadth of potential application for TroVax and increase ourconfidence in its therapeutic effect as we start Phase III development." -Ends- For further information, please contact: Oxford BioMedica plc:Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Tel: +44 (0)20 7466 5000 Scientific/Trade Press Enquiries:Gemma Bradley/ Susan Yu/ Katja Stout Tel: +44 (0)20 3008 7550Northbank 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. TroVax has attractedexternal support from Cancer Research UK, the US National Cancer Institute andthe UK clinical trials network, QUASAR. Over 150 patients have now been treatedwith TroVax in ten clinical trials (collectively over 500 doses). The Company istargeting colorectal 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 is starting aPhase III trial (TRIST - TroVax Renal Immunotherapy Survival Trial) in 700patients with advanced renal cell carcinoma in the second half of 2006. TheTRIST study received a Special Protocol Assessment from the US Food and DrugAdministration in May 2006. A Phase II trial in prostate cancer is ongoing and atrial in breast cancer is due to start under the auspices of the US SouthwestOncology Group. This information is provided by RNS The company news service from the London Stock Exchange