24th Jan 2007 07:02
Oxford Biomedica PLC24 January 2007 For Immediate Release 24 January 2007 Oxford BioMedica Reports AVIAN TRANsGENIC Milestone: Interferon Alpha Expressed in Eggs Oxford, UK - 24 January 2007: Oxford BioMedica (LSE: OXB), a leading genetherapy company, and its collaborative partners in the field of aviantransgenics, Viragen, Inc. (AMEX: VRA) and Roslin Institute, today announced anew achievement with the successful expression of human interferon alpha-2a inthe whites of eggs laid by transgenic hens using the OVA(TM)System (AvianTransgenic Biomanufacturing). This is the third therapeutic protein expressedthus far in a series of "proof-of-principle" studies, which aim to develop theOVA(TM)System as a novel, large-scale biomanufacturing alternative capable ofcost-effectively expressing many types of therapeutic proteins. Viragen holdsthe worldwide exclusive license to commercialize Avian Transgenic Technology asgranted by Roslin Institute. Alpha interferon is a protein produced by the human immune system that isfundamental to the body's resistance to disease. This OVATM-expression studyproduced interferon alpha-2a, which is the active ingredient in Roferon(R)-A(Roche), a drug approved for the treatment of certain chronic infectiousdiseases and cancers. Importantly, the team has previously demonstrated that theOVA(TM)System can repeatedly target expression to the oviduct and incorporationin the egg, rather than being expressed throughout the bird, plus thecharacteristic of protein drug expression is able to be passed to subsequentgenerations. This combination of features is essential for a viable andcost-competitive manufacturing system. Viragen has previously reported successful OVATM-expression of a humanizedmonoclonal antibody it is developing for advanced malignant melanoma andinterferon beta-1a, which is currently marketed under two competing brand namesfor the treatment of Multiple Sclerosis (MS), as Avonex(R) (Biogen Idec) andRebif(R) (Merck Serono). The Project's Scientific Leader, Dr. Helen Sang of Scotland's Roslin Institute,commented, "With each new functional protein that we recover from transgenichens' eggs, synthesized as a component of the egg white, we significantlyadvance our collective knowledge and experience. We have now demonstratedsynthesis of three different proteins at a consistent level and will move on tocharacterize OVATM-expressed interferon alpha to further refine and optimize thetechnology." According to Vice President and Managing Director of Viragen (Scotland) Ltd.,Dr. Karen Jervis, the OVA(TM)System production method differs dramatically fromstandard interferon manufacturing methods. "Typically, single-subtype,recombinant alpha interferon is manufactured in bacterial or mammalian cells inbioreactors housed in complex and costly facilities. With the OVA(TM)System, weexpect to offer large-scale manufacturing capabilities in a setting far lesscapital-intensive and with high levels of efficiency and quality. Mostimportantly, OVATM-expressed proteins will need to adhere to extremely stringentquality standards, and we are proceeding with comprehensive internal andexternal studies to fully characterize the proteins we express throughbiochemical and functional testing. These data, if positive, will be pivotal inpreparing both a compelling economical model and a safety/quality case for theregulatory authorities." "I congratulate the Viragen, Roslin and Oxford BioMedica teams that all playedkey roles in adding another therapeutic candidate to our portfolio ofOVATM-expressed proteins," stated Viragen's President and CEO, Charles A. Rice."This alliance continues to pioneer advancements in the field of transgenic henprotein production, and as we gather additional supporting evidence, we willpursue strategies designed to expedite a regulatory pathway for one candidate,which we expect to ultimately lead to key commercial licenses." Professor Alan Kingsman, Oxford BioMedica's Chief Executive Officer commented:"The collaboration with Viragen and the Roslin Institute to develop an effectiveavian transgenic system for biomanufacturing goes from strength to strength.This milestone further demonstrates the commercial potential of thistechnology." -Ends- For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000 Professor Alan Kingsman, Chief ExecutiveViragen, Inc: Tel: (954) 233 8746 Director of Communications, Doug CalderCity/Financial Enquiries: Tel: +44 (0)20 7466 5000 Lisa Baderoon/ Mark Court/ Mary-Jane Johnson BuchananCommunicationsScientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7550 Gemma 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. The OVA(TM)System Viragen holds the worldwide exclusive license to commercialize the OVA(TM)System(Avian Transgenic Biomanufacturing) as granted by the Roslin Institute(Scotland). The project is designed to develop the chicken into a pharmaceuticalbioreactor, one that can meet the growing need for protein-based humantherapeutics. Based on the creation of lines of transgenic hens which have beenengineered to produce a target protein in their eggs using the LentiVector(R)gene delivery system licensed from Oxford BioMedica plc, this technology isbeing developed as an efficient and economical alternative to standardbio-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, we are abio-pharmaceutical company engaged in the research, development, manufacture andcommercialization of therapeutic proteins for the treatment of cancers and viraldiseases. Our product and product candidate portfolio includes: Multiferon(R)(multi-subtype, human alpha interferon) which is uniquely positioned in valuableniche indications, such as high-risk malignant melanoma, other niche cancerindications and selected infectious diseases; VG101, a humanized monoclonalantibody that binds selectively to an antigen over-expressed on Stage IVmalignant melanoma tumors; and VG102, a highly novel humanized monoclonalantibody that binds selectively to an antigen that is over-expressed on nearlyall solid tumors. We are also pioneering the development of the OVA(TM)System(Avian Transgenics), with the renowned Roslin Institute, the creators of "Dollythe Sheep", as a revolutionary manufacturing platform for the large-scale,efficient and economical production of human therapeutic proteins andantibodies, by expressing these products in the egg whites of transgenic hens. 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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