Single Egg Contains Enough Interferon to Treat 15 HCV Patients
PLANTATION, Fla., May 7 /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 significant breakthrough in the development of the
OVA(TM) System, resulting in a more efficient bio-manufacturing platform
for the cost- effective production of human therapeutic proteins. The
OVA(TM) System is Viragen's avian transgenic proprietary technology.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-b )
Viragen reported that its researchers in Scotland and its collaborators
at Roslin Institute were able to significantly increase expression levels
of interferon alpha-2a, a human protein often prescribed for the treatment
of hepatitis C and certain malignant diseases, by at least 10-fold over
previously reported results. The high quantities of active protein now
being recovered from these transgenic hens' eggs builds a compelling case
for using the OVA(TM) System as a primary manufacturing system. Additional
protein drug candidates will be evaluated in confirmatory studies.
"This achievement may be the catalyst to establish the OVA(TM) System
as the leading transgenic manufacturing system for difficult-to-manufacture
proteins that can be enormously expensive to produce," stated Dr. Karen
Jervis, Managing Director of Viragen (Scotland) Ltd. "We first reported the
expression of interferon alpha in the OVA(TM) System back in January, but
we have now further optimized the efficiency of the process by using a
modified proprietary regulatory sequence, resulting in a 10-fold increase
over previous expression levels. We have every reason to believe these
results will translate to other high value therapeutic proteins that we aim
to express using the OVA(TM) System."
A regulatory sequence is a region of DNA associated with a gene that
influences the expression of that gene.
Roslin Institute's Dr. Helen Sang commented, "We are very encouraged to
have made another significant step in advancing the development of the
OVA(TM) System by increasing the yield per egg of interferon alpha ten
fold. We expect to confirm that we can maintain, and even improve upon
these results, for the production of interferon and other protein drugs."
Dr. Elizabeth Elliot, Senior Project Leader at Viragen Scotland,
stressed the potential impact of the increased yields being obtained, "Our
initial studies producing interferon alpha yielded an expression level of
approximately 4 milligrams in each egg. But when we used the new modified
regulatory sequence, we expressed up to 40 milligrams per egg. Based on
these expression levels, each egg contains enough alpha interferon to treat
up to 15 patients suffering from hepatitis C (HCV) for a full year, which
our estimates indicate could be produced at a substantial discount to the
cost compared to traditional recombinant systems. We are proceeding with
additional studies, striving to report abundant expression levels for other
proteins in order to validate such economical benefits."
About the OVA(TM) System:
Viragen has developed the technology underpinning the OVA(TM) System
(Avian Transgenic Biomanufacturing) in collaboration with the Roslin
Institute (Scotland) and now seeks to commercialize the considerable
know-how and proprietary technologies which form the overall manufacturing
process. The technology utilizes the chicken as 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 expected to provide an efficient and economical
alternative to traditional recombinant 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 portfolio includes:
Multiferon(R) (multi- subtype, human alpha interferon) which is uniquely
positioned in valuable niche indications, such as high-risk malignant
melanoma, and other select cancers and infectious diseases; VG102, a novel
monoclonal antibody that binds selectively to an antigen that is
significantly over-expressed on nearly all malignant tumors; and VG106, a
novel cytokine targeting difficult-to-treat cancers. We are also pioneering
the development of The OVA(TM) System with the renowned Roslin Institute,
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
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AP Archive: http://photoarchive.ap.org
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CONTACT:
Douglas Calder, Director of Communications,
Viragen, Inc., +1-954-233-8746, or dcalder@viragen.com
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