Oxford Biomedica Announces Publication Of Avian Transgenic Results In Leading U.S. Scientific Journal

Announced that the Proceedings of the National Academy of Sciences of the United States of America (PNAS), a leading scientific journal, has published an article profiling the avian transgenic (OVA™) system’s ability to express two therapeutic proteins in the whites of eggs of transgenic hens.

OXFORD, UK |  Jan 16, 2007 |
Oxford BioMedica (LSE: OXB), a leading gene therapy company, and its collaborative partners in the field of avian transgenics, Viragen, Inc. (AMEX: VRA) and Roslin Institute, today announced that the Proceedings of the National Academy of Sciences of the United States of America (PNAS), a leading scientific journal, has published an article profiling the avian transgenic (OVA™) system’s ability to express two therapeutic proteins in the whites of eggs of transgenic hens. The OVA™ System is being developed as a novel, large-scale biomanufacturing alternative, capable of cost-effectively expressing many types of therapeutic proteins.

The article, entitled, “Oviduct-specific expression of two therapeutic proteins in transgenic hens”, reports on the production of two protein drug candidates: a humanized monoclonal antibody being developed by Viragen for advanced malignant melanoma and interferon beta-1a, which is currently marketed under two competing brand names for the treatment of Multiple Sclerosis (MS), as Avonex® (Biogen Idec) and Rebif® (Serono).

Article Summary:
Recent advances in avian transgenesis have led to the possibility of utilizing the laying hen as a production platform for the large-scale synthesis of pharmaceutical proteins. Ovalbumin constitutes more than half of the protein in the white of a laid egg, and expression of the ovalbumin gene is restricted to the tubular gland cells of the oviduct. Here we describe the use of lentiviral vectors to deliver transgene constructs comprising regulatory sequences from the ovalbumin gene designed to direct synthesis of associated therapeutic proteins to the oviduct. We report the generation of transgenic hens that synthesize functional recombinant pharmaceutical protein in a tightly regulated tissue-specific manner, without any evidence of transgene silencing after germ-line transmission.

According to Viragen Vice President, Dr. Karen Jervis, who is Managing Director of Viragen’s Scotland operations, additional avian transgenic milestones are expected shortly: “We are very pleased that the PNAS article chronicles our ‘proof-of-principle’ studies resulting in successful germline transmission of two therapeutic proteins, and we expect to report excellent new results with a third protein-drug candidate by the end of this month, assuming positive confirmations,” stated Dr. Jervis.

Professor Alan Kingsman, Oxford BioMedica’s Chief Executive Officer commented: “We are delighted by the progress of our collaborative partners towards the commercialisation of the OVA™ System. This technology could address a substantial need in the biopharmaceutical industry for efficient, high-volume production of biological products.”

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1. Oxford BioMedica plc

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.

Oxford Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes two clinical candidates and a preclinical targeted antibody therapy, which is being developed in collaboration with Wyeth. The Company has started Phase III development of its lead cancer immunotherapy product, TroVax, in renal cancer and multiple Phase II trials in various cancer settings are ongoing or planned. In neurotherapy, the Company's lead product, ProSavin, is expected to enter clinical trials in Parkinson's disease in 2007. The preclinical pipeline includes gene-based products for vision loss, motor neuron disease and nerve repair.

The The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec, GSK and Pfizer.

Further information is available at www.oxfordbiomedica.co.uk
2. The OVA™ System
Viragen holds the worldwide exclusive license to commercialize the OVA™ System (Avian Transgenic Biomanufacturing) as granted by the Roslin Institute (Scotland). The project is designed to develop the chicken into a pharmaceutical bioreactor, one that can meet the growing need for protein-based human therapeutics. Based on the creation of lines of transgenic hens which have been engineered to produce a target protein in their eggs using the LentiVector® gene delivery system licensed from Oxford BioMedica plc, this technology is being developed as an efficient and economical alternative to standard bio-manufacturing techniques, having many apparent advantages in ease of scale-up, lower costs of production and quality of product produced.

This project has been funded in part from a grant awarded by the Scottish Executive’s “SPUR Plus Program”, designed to support significant technological advances being made in Scotland.

To view BBC News reports on OVA™ System, please visit: http://news.bbc.co.uk/2/hi/science/nature/6261427.stm
3. Proceedings of the National Academy of Sciences (PNAS)

PNAS is one of the world's most-cited multidisciplinary scientific serials. Since its establishment in 1914, it continues to publish cutting-edge research reports, commentaries, reviews, perspectives, colloquium papers, and actions of the Academy. Coverage in PNAS spans the biological, physical, and social sciences. PNAS is published weekly in print, and daily online in PNAS Early Edition. For more information, please visit: http://www.PNAS.org

Patient enrolment commenced in November 2006. Approximately 700 patients will be recruited from about 120 centres in the USA, European Union and Eastern Europe. The primary endpoint for the trial is survival improvement and secondary endpoints include progression-free survival, tumour response rates and quality of life scores. A Safety and Efficacy Monitoring Board (SEMB) will assess the safety and potential efficacy of the drug combinations at various time points during the trial. In May 2006, Oxford BioMedica received a Special Protocol Assessment agreement for the TRIST study from the US Food and Drug Administration.

Median survival for patients with advanced or metastatic renal cell carcinoma is approximately 11 months. The duration of the trial will be determined by the number of survival events (deaths) in the study group and it is expected to reach a conclusion in 2008-09.
4 Viragen, Inc.
With international operations in the U.S., Scotland and Sweden, we are a bio-pharmaceutical company engaged in the research, development, manufacture and commercialization of therapeutic proteins for the treatment of cancers and viral diseases. Our product and product candidate portfolio includes: Multiferon® (multi-subtype, human alpha interferon) which is uniquely positioned in valuable niche indications, such as high-risk malignant melanoma, other niche cancer indications and selected infectious diseases; VG101, a humanized monoclonal antibody that binds selectively to an antigen over-expressed on Stage IV malignant melanoma tumors; and VG102, a highly novel humanized monoclonal antibody that binds selectively to an antigen that is over-expressed on nearly all solid tumors. We are also pioneering the development of the OVA™ System (Avian Transgenics), with the renowned Roslin Institute, the creators of “Dolly the Sheep”, as a revolutionary manufacturing platform for the large-scale, efficient and economical production of human therapeutic proteins and antibodies, by expressing these products in the egg whites of transgenic hens.

For more information, please visit: http://www.Viragen.com

SOURCE: Oxford BioMedica

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