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Viragen, Inc. (VRA) And AFG Biosolutions, Inc. Report Positive Anti-Viral Drug Data


11/29/2006 11:46:30 AM

PLANTATION, Fla., Nov. 28 /PRNewswire-FirstCall/ -- Viragen, Inc. and its majority-owned subsidiary, Viragen International, Inc. , 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.

Photo: http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-bAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comViragen, Inc.

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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