Oxford Biomedica Regulatory News (OXB)

2 Aug 2007 07:02

Oxford Biomedica PLC02 August 2007 For Immediate Release 2 AUGUST 2007 OXFORD BIOMEDICA: PUBLICATION OF TROVAX(R) PHASE II CLINICAL TRIAL DATA Oxford, UK: 2 August 2007: Oxford BioMedica (LSE: OXB), a leading gene therapycompany, announced that data from its Phase II clinical trial of TroVax incolorectal cancer patients who were also receiving chemotherapy under the FOLFOXregime has been published in the 1 August 2007 edition of Clinical CancerResearch, a journal of the American Association for Cancer Research ('AACR').AACR has issued the following announcement: "Phase II Study of Therapeutic Vaccine Shows Efficacy in Patients withMetastatic Colorectal Cancer PHILADELPHIA - A therapeutic cancer vaccine has shown effectiveness when givenalongside chemotherapy to patients with metastatic colorectal cancer in a phaseII trial, according to researchers at Oxford BioMedica (UK) Ltd. The study foundthat six of the 17 metastatic colorectal cancer patients in the study showedtumor shrinkage, classified as complete or partial responses followingindependent expert review. The study, reported in the August 1 issue of Clinical Cancer Research, a journalof the American Association for Cancer Research, was designed to demonstrate thesafety and immunogenicity of the vaccine, called modified vacciniaAnkara-encoding 5T4 (TroVax(R)), when used alongside standard chemotherapy. Theresearch was funded by Oxford BioMedica which is developing the vaccine inpartnership with Sanofi-Aventis. Unlike preventative vaccines, such as the human papillomavirus vaccine toprevent cervical cancer, TroVax is a therapeutic vaccine, designed to stimulatethe immune systems of patients who already have cancer. The vaccine consists ofan attenuated (non-disease causing) version of the vaccinia virus modified todeliver the gene for 5T4, a protein found in many tumors. "The idea is that the modified virus enters cells, produces the tumor proteinand stimulates the immune system," said lead study author Richard Harrop, Ph.D.,vice president of clinical immunology at Oxford BioMedica. "To give a vaccinealongside chemotherapy might seem counterintuitive, since chemotherapy canweaken the immune system, but our study shows that TroVax could be complementaryto standard chemotherapy, enhancing the immune response to tumors." The target of this immuno-therapy approach is a tumor antigen called 5T4, aprotein embedded within the membrane of cancer cells. The protein is rarelyfound in normal tissues, but is produced at high levels by a wide range of humancancers, including colorectal, renal, gastric and ovarian. The production of 5T4has been associated with cancer metastasis and poor prognosis for patients. "Typically, the immune system doesn't pay attention to this molecule, so byproducing 5T4 artificially in combination with the 'danger signals' associatedwith a viral infection, we are demanding that the immune system take notice,"Harrop said. "TroVax causes cells at the injection site to produce 5T4 in a waywhich agitates the immune system into producing antibodies and killer T cells.It is hoped that these two components of the immune system then migrate totumors and kill them without harming any normal tissues." "In essence, it's like turning up your stereo in the hopes that it will attractthe police to your neighbor's rowdy party," Harrop said. Harrop and his colleagues administered the vaccine to 17 patients withmetastatic colorectal cancer just before, during and after the patients weretreated with the standard chemotherapy regimen FOLFOX which consists of theagents: 5-fluorouracil, folinic acid and oxaliplatin. Through the course of the study, the researchers monitored the patients for animmune response to 5T4. Eleven of the 17 patients who received the completecourse of vaccinations (six injections) mounted strong immune responses to the5T4 tumor protein. Of these 11 patients, six exhibited significant shrinkage oftheir tumors and one patient no longer had any detectable tumors. Researchersnoted no complications stemming from TroVax vaccination or any other evidencethat would call into question the safety of the vaccine. While the study was not designed to prove that patients survived longer thanwould normally be expected, the researchers noted that, on average, the overallmedian survival was 68 weeks in all 17 vaccinated patients and 118 weeks in the11 patients who received all six vaccinations. According to Harrop, the researchers are currently testing the vaccine in aphase III trial in renal cancer patients in the U.S. and Europe and SanofiAventis is planning a phase III study in colorectal cancer." -Ends- For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor Alan Kingsman, Chief ExecutiveCity/Financial Enquiries: Tel: +44 (0)20 7466 5000Lisa Baderoon/ Mark Court/ Mary-Jane Johnson BuchananCommunicationsScientific/Trade Press Enquiries: Tel: +44 (0)20 7268 3002Gemma Price/ Holly Griffiths/ Katja StoutNorthbank Communications 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 sanofi-aventis is implementing adevelopment plan for colorectal cancer. Oxford BioMedica's oncology pipelineincludes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, whichhas completed two clinical trials. In neurotherapy, the Company's lead product,ProSavin(R), is expected to enter clinical development for Parkinson's diseasein 2007. The neurotherapy pipeline also includes preclinical gene-basedtherapeutics for vision loss, motor neuron disease and nerve 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 the targeted antibody therapy.The Company also has collaborations with Sigma-Aldrich, MolMed and Virxsys.Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline andPfizer. 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. In 2006, Oxford BioMedica started a Phase III trial of TroVax in renal cancerand sanofi-aventis is implementing a development plan for colorectal cancer. Theproduct has attracted support from Cancer Research UK, the US National CancerInstitute, and the UK clinical trials network, QUASAR. These organisations areconducting or plan to conduct clinical trials with TroVax. For more information on the ongoing phase III study of TroVax visit:www.trovax.co.uk This information is provided by RNS The company news service from the London Stock Exchange