10th Jan 2007 07:01
Oxford Biomedica PLC10 January 2007 For Immediate Release 10 January 2007 Oxford BioMedica's Phase III trial of TroVax(R) in renal cancer adopted by UK clinical trial network Oxford, UK - 10 January 2007: Oxford BioMedica (LSE: OXB), a leading genetherapy company, today announced that the Phase III TRIST trial of its novelcancer immunotherapy, TroVax, in patients with renal cancer, has been adopted bythe UK National Cancer Research Network (NCRN). The NCRN provides the UK National Health Service (NHS) with the infrastructureto support cancer clinical trials. The NCRN's adoption of Oxford BioMedica'sTRIST trial means that various NHS centres are able to participate in the study,which should facilitate rapid recruitment of patients in the UK. The UKDepartment of Health established the NCRN in April 2001 and it has alreadysucceeded in more than tripling national recruitment into cancer clinicaltrials. In reaching its decision to adopt the TRIST trial, the Renal CancerClinical Studies Group of the NCRN evaluated TroVax and the trial design, andconcluded that the product offers potential improvement in patient care for theNHS. There are no financial obligations or loss of commercial rights throughNCRN's involvement. TRIST (TroVax Renal Immunotherapy Survival Trial) is a multi-centre Phase IIItrial of TroVax in patients with advanced or metastatic renal cell carcinoma.The first patient was treated in the TRIST study in November 2006. Sites arecurrently open in the European Union and Eastern Europe. Oxford BioMedicaanticipates US sites to start recruiting patients shortly. The target is torecruit 700 patients in total and the trial is expected to reach a conclusion in2008-09, which would support the Company's objective of reaching productregistration in 2009. Professor Barry Hancock, Chairman of the Renal Clinical Studies Group, said: "Weare very pleased to support this study. TroVax appears particularly welltolerated and is effective at inducing a significant immune response against aprotein which marks out tumour cells. There is a real need for novel, safe andeffective treatments for this aggressive form of cancer. We aim to facilitaterapid patient recruitment through the participation of our network of centres inthe UK." Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on theNCRN news: "The involvement of NCRN in the first Phase III trial of TroVax is astrong endorsement of the product and the trial design. Patient recruitment isnow underway in several countries but we are particularly pleased that, throughthe NCRN, we will have the participation of additional UK centres." Professor Alan Kingsman, Oxford BioMedica's Chief Executive Officer commented:"We are delighted that NCRN has adopted TRIST in the UK. The ongoing recruitmentcontinues to enhance the value of the TroVax portfolio as we make progresstowards a deal for this exciting product." -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 3008 7550Gemma Bradley/ Holly Griffiths/ 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, GSK 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. Oxford BioMedica has started a Phase III trial (TRIST) inadvanced renal cell carcinoma. A Phase II trial in prostate cancer is ongoingand a trial in breast cancer is due to start under the auspices of the USSouthwest 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. 3. Phase III TRIST Trial TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial that isdesigned to evaluate whether TroVax immunotherapy, added to first-line standardof care therapy, prolongs the survival of patients with locally advanced ormetastatic clear cell renal carcinoma. The trial is a randomised,placebo-controlled, two-arm study that will compare TroVax in combination withstandard of care to placebo with standard of care. The standard of caretherapies will be interleukin-2, interferon-alpha or Sutent(R) (sunitinib). Theprotocol stratifies treatment between the standard of care options to ensurethat the allocation of TroVax and placebo is rigorously balanced. Patient enrolment commenced in November 2006. Approximately 700 patients will berecruited from about 120 centres in the USA, European Union and Eastern Europe.The primary endpoint for the trial is survival improvement and secondaryendpoints include progression-free survival, tumour response rates and qualityof life scores. A Safety and Efficacy Monitoring Board (SEMB) will assess thesafety and potential efficacy of the drug combinations at various time pointsduring the trial. In May 2006, Oxford BioMedica received a Special ProtocolAssessment agreement for the TRIST study from the US Food and DrugAdministration. Median survival for patients with advanced or metastatic renal cell carcinoma isapproximately 11 months. The duration of the trial will be determined by thenumber of survival events (deaths) in the study group and it is expected toreach a conclusion in 2008-09. 4. The National Cancer Research Network The National Cancer Research Network (NCRN) was created in response to the needto improve the infrastructure within the UK National Health Service (NHS) forclinical research in cancer and to ensure that research is better integratedwith cancer care as outlined in the 2000 Report of the Science and TechnologyCommittee on Cancer Research. The NCRN provides the NHS with the infrastructureto support cancer clinical trials in England. Its aim is to improve the speed,quality and integration of research with the ultimate aim of improving patientcare. NCRN was established by the Department of Health in April 2001 and hasalready succeeded in more than tripling national recruitment into cancerclinical trials. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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