PLANTATION, Fla., Jan. 16 /PRNewswire-FirstCall/ -- Viragen, Inc. and its collaborative partners in the field of avian transgenics, Roslin Institute and Oxford Biomedica Plc , 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 OVA(TM) System’s ability to express two therapeutic proteins in the whites of eggs of transgenic hens. The OVA(TM) 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(R)* (Biogen Idec) and Rebif(R)** (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.
To view BBC News reports on OVA(TM) System, please visit: http://news.bbc.co.uk/2/hi/science/nature/6261427.stm
About 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 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(R) 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.
*Avonex(R) (interferon beta-1a) is a registered trademark of Biogen Idec, Inc.
** Rebif(R) (interferon beta-1a) is a registered trademark of Serono, Inc.
Viragen has no agreements with Biogen Idec or Serono and did not collaborate with either company in connection with these avian expression studies.
About 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
About 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(R) (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(TM) 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 Viragen, Inc. Corporate Contact: Douglas Calder, Director of Communications Phone: (954) 233-8746; Fax: (954) 233-1414 E-mail: dcalder@viragen.com
The foregoing press announcement contains forward-looking statements that can be identified by such terminology such as “believes,” “expects,” “potential,” “plans,” “suggests,” “may,” “should,” “could,” “intends,” or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management’s expectations regarding future research, development and/or commercial results could be affected by, among other things, uncertainties relating to clinical trials and product development; availability of future financing; unexpected regulatory delays or government regulation generally; the success of third- party marketing efforts; our ability to retain third-party distributors; our ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. Forward-looking statements speak only as to the date they are made. The Company does not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.
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CONTACT: Douglas Calder, Director of Communications of Viragen, Inc.,+1-954-233-8746, or Fax, +1-954-233-1414, or dcalder@viragen.com