PLANTATION, Fla., Jan. 16 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA; VRA.U; VRA.WS) and its collaborative partners in the field of
avian transgenics, Roslin Institute and Oxford Biomedica Plc (LSE: OXB),
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.
SOURCE Viragen, Inc.
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Related links:
http://www.viragen.com
http://news.bbc.co.uk/2/hi/science/nature/6261427.stm
http://www.PNAS.org
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-b
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Douglas Calder, Director of Communications of
Viragen, Inc., +1-954-233-8746, or Fax, +1-954-233-1414, or
dcalder@viragen.com
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