8th May 2007 07:03
Oxford Biomedica PLC08 May 2007 For Immediate Release 8 MAY 2007 OXFORD BIOMEDICA'S COLLABORATORS IN TRANSGENICS ACHIEVE EXPRESSION BREAKTHROUGH USING OVA(TM) SYSTEM FOR THERAPEUTIC PROTEIN PRODUCTION Single Egg Contains Enough Interferon to Treat 15 Patients with Hepatitis C Oxford, UK: 8 May 2007: Oxford BioMedica (LSE: OXB), the leading gene therapycompany, announced today that its collaborative partners in the field of aviantransgenics, Viragen, Inc. (AMEX: VRA) and Roslin Institute, have reported asignificant breakthrough in the development of the OVA(TM) System, resulting in a more efficient bio-manufacturing platform for the cost-effective production ofhuman therapeutic proteins. The OVA(TM) System is Viragen's avian transgenicproprietary technology, which uses the LentiVector(R) gene delivery systemlicensed from Oxford BioMedica to create transgenic hens that produce a targetprotein in their eggs. Viragen reported that its researchers in Scotland and its collaborators atRoslin Institute were able to significantly increase expression levels ofinterferon alpha-2a, a human protein often prescribed for the treatment ofhepatitis C and certain malignant diseases, by at least ten-fold over previouslyreported results. The high quantities of active protein now being recovered fromthese transgenic hens' eggs builds a compelling case for using the OVA(TM)System as a primary manufacturing system. Additional protein drug candidateswill be evaluated in confirmatory studies. "This achievement may be the catalyst to establish the OVA(TM) System as theleading transgenic manufacturing system for difficult-to-manufacture proteinsthat can be enormously expensive to produce," stated Dr. Karen Jervis, ManagingDirector of Viragen (Scotland) Ltd. "We first reported the expression ofinterferon alpha in the OVA(TM) System back in January, but we have now furtheroptimised the efficiency of the process by using a modified proprietaryregulatory sequence, resulting in a ten-fold increase over previous expressionlevels. We have every reason to believe that these results will translate toother high value therapeutic proteins that we aim to express using the OVA(TM)System." A regulatory sequence is a region of DNA associated with a gene that influencesthe expression of that gene. Roslin Institute's Dr. Helen Sang commented, "We are very encouraged to havemade another significant step in advancing the development of the OVA(TM) Systemby increasing the yield per egg of interferon alpha ten-fold. We expect toconfirm that we can maintain, and even improve upon these results, for theproduction of interferon and other protein drugs." Dr. Elizabeth Elliot, Senior Project Leader at Viragen Scotland, stressed thepotential impact of the increased yields being obtained, "Our initial studiesproducing interferon alpha yielded an expression level of approximately fourmilligrams in each egg. But when we used the new modified regulatory sequence,we expressed up to 40 milligrams per egg. Based on these expression levels, eachegg contains enough alpha interferon to treat up to 15 patients suffering fromhepatitis C for a full year, which our estimates indicate could be produced at asubstantial discount compared to the cost of traditional recombinant systems. Weare proceeding with additional studies, striving to report abundant expressionlevels for other proteins in order to validate such economical benefits." -Ends- For further information, please contact: Oxford BioMedica plc:Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 Viragen, Inc:Director of Communications, Doug Calder Tel: (954) 233 8746 City/Financial Enquiries:Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000Buchanan Communications Scientific/Trade Press Enquiries:Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7268 3002Northbank 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 the areas of oncology and neurotherapy. The Companywas established in 1995 as a spin-out from Oxford University, and is listed onthe London Stock Exchange. 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 beingdeveloped and commercialised in collaboration with Sanofi-Aventis. TroVax is inPhase III development for renal cancer 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. Inaddition, the Company has a platform technology for therapeutic vaccines forinfectious diseases. 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 75 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Corporatepartnerships include the collaboration on TroVax with Sanofi-Aventis and on atargeted antibody therapy with Wyeth. Intervet, Sigma-Aldrich, Viragen, MolMedand Virxsys are also corporate partners. Technology licensees include Merck &Co, Biogen Idec, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. The OVA(TM) System Viragen has developed the technology underpinning the OVA(TM) System (AvianTransgenic Bio-manufacturing) in collaboration with the Roslin Institute(Scotland) and now seeks to commercialise the considerable know-how andproprietary technologies which form the overall manufacturing process. Thetechnology utilises the chicken as a pharmaceutical bioreactor, one that canmeet the growing need for protein-based human therapeutics. Based on thecreation of lines of transgenic hens, which have been engineered to produce atarget protein in their eggs using the LentiVector(R) gene delivery systemlicensed from Oxford BioMedica, this technology is expected to provide anefficient and economical alternative to traditional recombinantbio-manufacturing techniques, having many apparent advantages in ease ofscale-up, lower costs of production and quality of product produced. This project has been funded in part from a grant awarded by the ScottishExecutive's "SPUR Plus Program", designed to support significant technologicaladvances being made in Scotland. 3. Viragen, Inc. With international operations in the U.S., Scotland and Sweden, Viragen is abio-pharmaceutical company engaged in the research, development, manufacture andcommercialisation of therapeutic proteins for the treatment of cancers and viraldiseases. The product portfolio includes: Multiferon(R) (multi-subtype, humanalpha interferon) which is uniquely positioned in valuable niche indications,such as high-risk malignant melanoma, and other select cancers and infectiousdiseases; VG102, a novel monoclonal antibody that binds selectively to anantigen that is significantly over-expressed on nearly all malignant tumours;and VG106, a novel cytokine targeting difficult-to-treat cancers. Viragen isalso pioneering the development of The OVA(TM) System with the Roslin Institute,creators of "Dolly the Sheep", as a revolutionary manufacturing platform for thelarge-scale, efficient and economical production of human therapeutic proteinsand antibodies, by expressing these products in the egg whites of transgenichens. For more information, please visit http://www.Viragen.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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