PLANTATION, Fla., Jan. 23 /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 (LSE: OXB), today
announced a new achievement with the successful expression of human
interferon alpha-2a in the whites of eggs laid by transgenic hens using the
OVA(TM) System (Avian Transgenic Biomanufacturing). This is the third
therapeutic protein expressed thus far in a series of "proof-of-principle"
studies, which aim to develop the OVA(TM) System as a novel, large-scale
biomanufacturing alternative capable of cost-effectively expressing many
types of therapeutic proteins. Viragen holds the worldwide exclusive
license to commercialize Avian Transgenic Technology as granted by Roslin
Institute.
Alpha interferon is a protein produced by the human immune system that
is fundamental to the body's resistance to disease. This OVA(TM)-expression
study produced interferon alpha-2a, which is the active ingredient in
Roferon(R)-A* (Hoffman-LaRoche Inc.), a drug approved for the treatment of
certain chronic infectious diseases and cancers. Importantly, the team has
previously demonstrated that the OVA(TM) System can repeatedly target
expression to the oviduct and incorporation in the egg, rather than being
expressed throughout the bird, plus the characteristic of protein drug
expression is able to be passed to subsequent generations. This combination
of features is essential for a viable and cost-competitive manufacturing
system.
Viragen has previously reported successful OVA(TM)-expression of a
humanized monoclonal antibody it is developing 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).
The Project's Scientific Leader, Dr. Helen Sang of Scotland's Roslin
Institute, commented, "With each new functional protein that we recover
from transgenic hens' eggs, synthesized as a component of the egg white, we
significantly advance our collective knowledge and experience. We have now
demonstrated synthesis of three different proteins at a consistent level
and will move on to characterize OVA(TM)-expressed interferon alpha to
further refine and optimize the technology."
According to Vice President and Managing Director of Viragen (Scotland)
Ltd., Dr. Karen Jervis, the OVA(TM) System production method differs
dramatically from standard interferon manufacturing methods. "Typically,
single-subtype, recombinant alpha interferon is manufactured in bacterial
or mammalian cells in bioreactors housed in complex and costly facilities.
With the OVA(TM) System, we expect to offer large-scale manufacturing
capabilities in a setting far less capital-intensive and with high levels
of efficiency and quality. Most importantly, OVA(TM)-expressed proteins
will need to adhere to extremely stringent quality standards, and we are
proceeding with comprehensive internal and external studies to fully
characterize the proteins we express through biochemical and functional
testing. These data, if positive, will be pivotal in preparing both a
compelling economical model and a safety/quality case for the regulatory
authorities."
"I congratulate the Viragen, Roslin and Oxford BioMedica teams that all
played key roles in adding another therapeutic candidate to our portfolio
of OVA(TM)-expressed proteins," stated Viragen's President and CEO, Charles
A. Rice. "This alliance continues to pioneer advancements in the field of
transgenic hen protein production, and as we gather additional supporting
evidence, we will pursue strategies designed to expedite a regulatory
pathway for one candidate, which we expect to ultimately lead to key
commercial licenses."
Viragen has no agreements with Hoffman-LaRoche, Biogen Idec or Serono
and did not collaborate with these companies in connection in these avian
expression studies.
* Roferon(R)-A (interferon alpha-2a) is a registered trademark of
Hoffman- LaRoche Inc.
** 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.
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.
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-b)
SOURCE Viragen, Inc.
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http://www.viragen.com
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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
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