Study Suggests Utility of Multiferon(R) Against Smallpox
PLANTATION, Fla., Nov. 28 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA; VRA.U; VRA.WS) and its majority-owned subsidiary, Viragen
International, Inc. (OTC Bulletin Board: VGNI), today announced results
from a preliminary, in vivo, anti-viral drug study conducted by AFG
BioSolutions, Inc., a prominent biodefense consultant to the U.S. Federal
Government. The study evaluated the use of Viragen's Multiferon(R)
(multi-subtype, human alpha interferon) and a vaccine-product chosen by
AFG. The study demonstrated that both products, alone and in combination,
were able to protect 100% of rabbits from rabbitpox virus (RPV) infection,
suggesting that these products possess potent anti-viral properties and are
ideal candidates to evaluate as preventatives for human smallpox.
AFG BioSolutions, headquartered in Germantown, Maryland, is committed
to discovering therapeutic solutions to combat biological weapons - threats
such as smallpox virus which, while largely eradicated decades ago, still
poses bioterrorism risks.
According to Dr. Ken Alibek, AFG's President and Chief Scientific
Officer, and author of Biohazard, "There are highly virulent strains of
smallpox that have been designed as bioweapons that could infect 60% to 90%
of a targeted population, with a subsequent death rate of 30% to 50% for
unvaccinated individuals. And while effective vaccines do exist against
known strains, there are insufficient doses available in the United States
to deal with an emergency situation in major cities. Furthermore, there
would be a delay between identifying a new, engineered strain and creating
an effective vaccine. Therefore, AFG is evaluating select anti-viral
products with the aim of making biodefense recommendations to the U.S.
Government, and in this early study, we targeted rabbitpox because it
serves as an excellent preliminary model for the development of therapies
for human smallpox."
The Study:
Small groups of rabbits were infected with a lethal dose of RPV intra-
nasally, and then treated intra-nasally with Multiferon(R) and/or a vaccine
that resembles the RNA of infectious viruses and is used to stimulate the
production of interferon by the immune system.
The study found several treatment regimens resulted in 100% survival of
the animals including: 1) high doses of Multiferon(R) alone; 2) vaccine
alone; and 3) Multiferon(R) and vaccine combined at different dose ranges.
Dr. Alibek elaborated on the findings, "While each product worked
alone, we found that a combination of the two products was more effective
at alleviating RPV symptoms including reducing the weight loss and fever.
While additional confirmatory studies will be necessary, these findings
support the concept for the development of a human alpha interferon nasal
spray combined with an interferon inducer, such as the vaccine we used, as
a highly effective therapeutic and/or prophylactic for viral threats, such
as smallpox." AFG BioSolutions intends to publish complete results of the
study.
These and potential future research studies represent preliminary
evaluations, and success cannot be guaranteed, therefore, Viragen is not
yet prepared to recommend Multiferon(R) as a prophylactic, preventive or
treatment for any biodefense application. However, continued mounting
scientific evidence will confirm or refute the Company's belief that
Multiferon(R) shows immuno-protective and anti-viral activity against
multiple viral targets, and holds the potential to be more effective than
other anti-viral products.
About AFG BioSolutions, Inc.:
AFG Biosolutions, located in Germantown, Maryland, is a research and
development company with unique capabilities for developing lead candidates
for vaccines, antibodies and other therapeutic and prophylactic
preparations. Using proprietary Rev-VAT(TM) technology, AFG intends to
extend its approach for developing antibody and vaccine candidates against
biological weapons - threats such as anthrax, smallpox, plague, and
tularemia into the area of naturally occurring infectious diseases,
cancers, and autoimmune diseases. AFG (formerly known as Advanced
Biosystems, Inc.) was founded in 1999 as a subsidiary of the Analex
Corporation (formerly known as Hadron, Inc.). In November 2004, AFG
co-founders Dr. Kenneth Alibek, Vaughn Forrest, and Dr. C.W. Gilluly
completed a management buyout of the company from Analex.
For more information, please visit: http://www.afgbio.com
About Multiferon(R):
Alpha interferon is produced by the human immune system and helps
improve the body's natural resistance to disease.
Multiferon(R) differs from single-subtype recombinant alpha interferon
drug products in that it contains a unique mixture of multiple subtypes of
human interferon (a1, a2, a8, a10, a14, a21). It is believed that each
subtype, some of which are glycosylated, employs a specific biological
activity, but more importantly, the subtypes act synergistically to elicit
an overall effect.
In February 2006, Multiferon(R) was approved in Sweden for the
first-line adjuvant treatment of high-risk malignant melanoma. Viragen is
proceeding with a regulatory strategy targeting approvals throughout the
broader European Union.
For more on prescription information, please visit:
http://www.Multiferon.com
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) 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 Company's 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://www.afgbio.com http://www.Multiferon.com
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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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