Armed Forces Institute Of Pathology To Conduct NanoViricides Animal Studies Against Bird Fl

NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), announced today that they have executed a Cooperative Research and Development Agreement (CRADA) with the Armed Forces Institute of Pathology (AFIP). This joint R&D effort will enable AFIP scientists to test the effectiveness of several NanoViricides, Inc. anti-viral nanomedicines against deadly bird flu viruses (H5N1) at their facilities.

"We are very excited to study the effectiveness of nanoviricides against the most current strains of H5N1 in animal models," said lead AFIP scientist Dr. Mina Izadjoo.

The H5N1 bird flu virus continues to spread further across the globe every year, while continuing to mutate. The accumulating mutations make a human pandemic ever more likely. Because the virus is continually changing its genomic structure, creating a vaccine against it is very difficult. It has been predicted that six to nine months will be needed to produce an effective vaccine in the case of a pandemic. Broad-spectrum antivirals that continue to be effective in the face of the mutations in the virus strain will therefore be essential for any effective response to a pandemic.

For a concise up-to-date summary, please visit http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/biofacts/avflu_human.html

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Effects Of Influenza A Virus Infection On Migrating Mallard Ducks

Mallard ducks are a main reservoir for low-pathogenic avian influenza virus in nature, yet surprisingly little is known about how infection affects these birds.

We analyzed 10,000 samples from migratory mallards in Sweden for presence of influenza virus and were able to demonstrate that infected birds were leaner than uninfected birds, and that weight loss was related to the amount of virus shed in their faeces.

Although many mallard populations are migratory, the short virus shedding time (often less than a week) imply that individual birds are not long-distance disperser of the virus on a continental scale.

Proceedings of the Royal Society B: Biological Sciences

Proceedings B is the Royal Society's flagship biological research journal, dedicated to the rapid publication and broad dissemination of high-quality research papers, reviews and comment and reply papers. The scope of journal is diverse and is especially strong in organismal biology.

http://www.publishing.royalsociety.org/proceedingsb

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Over 80,000 Chickens To Be Killed In Hong Kong After Bird Flu Found

Authorities in Hong Kong say over 80,000 chickens will be culled after a poultry farm was found to have chickens infected with avian influenza (bird flu). The last time bird flu was detected in Hong Kong was in 2002.

About 60 dead chickens were found in the farm, according to York Chow, Health Secretary. Tests have confirmed the birds died from the H5N1 virus - the most virulent strain. He added that all chickens within a 2-mile (3-km) radius of the infected farm will be culled. Just one other farm is within that area.

Two New Confirmed Human Bird Flu Cases in Indonesia

The Indonesian Ninistry of Health says there are two new confirmed cases of human infection with the H5N1 avian influenza virus.

A nine-year-old girl from Riau Province became ill on November 7th and was hospitalized on November 12th. She made a full recovery and left hospital on November 27th. Laboratory tests confirmed H5N1 infections. Authorities say an investigation points to dead poultry near her home as the source.

A two-year-old girl from East Jakarta developed symptoms on November 18th, and was taken to hospital on November 26th - she died three days later. Tests confirmed H5N1 infection. Investigations indicate she had been possibly exposed at a live bird market.

139 people have become ill with the H5N1 avian influenza virus to date in Indonesia - 113 of them died.

What is Bird Flu (Avian Influenza)?

Bird flu (avian influenza) is a disease caused by viruses. It is a contagious disease which infects only birds, and occasionally pigs. The avian influenza viruses attack specific species - they have sometimes jumped the species barrier and infected people. However, this has been extremely rare, and continues to be rare.

As far as farmed birds are concerned (poultry), there are two main types of avian influenza - one is fairly mild while the other is deadly (for birds).

Scientists fear the H5N1 bird flu strain may eventually mutate and infect humans more easily. If this happens there is a risk of a global pandemic.

Mild

Low pathogenic forms of bird flu may cause a bird to have more ruffled feathers and lay fewer eggs. This form is often undetected among farmed poultry (in many cases the bird is infected, and then gets better and nobody noticed).

Deadly (H5N1)

The highly pathogenic form of bird flu is much more dangerous. It has a mortality rate of virtually 100% and spreads very rapidly among flocks of birds. A bird infected with the more virulent type of bird flu (the highly pathogenic form) experiences deterioration of many internal organs.

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Vical Pandemic Influenza Vaccines Achieve T-Cell Responses And Cross-Clade Reactivity In Humans

Vical Incorporated (Nasdaq: VICL) announced that the company's Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines induced T-cell responses against a matching strain of influenza virus and demonstrated cross-clade antibody responses against a different strain in a Phase 1 clinical trial. The company previously reported that the vaccines had achieved potentially protective levels of antibody responses in up to 67% of evaluable subjects in the trial's higher dose cohorts. Vical researchers presented the expanded data, as well as new nonclinical data from the company's RapidResponse(TM) DNA vaccine manufacturing program, this week at the DNA Vaccines 2008 Conference (Las Vegas - December 9-11).

H5N1 Pandemic Influenza Vaccine Phase 1 Trial Update

New data presented at the conference indicates that the company's monovalent Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccine induced T-cell responses against the H5 antigen in 75% to 100% of evaluable subjects in the various cohorts. T-cell responses could be important in protecting against serious disease and in limiting the spread of disease during an outbreak.

The monovalent vaccine, which was based on the H5N1 influenza virus strain, A/Vietnam/1203/04, also induced antibody responses against the H5N1 influenza virus strain, A/Hong Kong/156/97 from a different clade, in 50% of responders. Cross-clade responses could be important in providing protection against emerging strains of influenza before a matching vaccine could be deployed.

Antibody and/or T-cell responses against the matching H5 antigen and the conserved NP and M2 antigens were detected in a majority of subjects receiving the trivalent vaccine. Responses against conserved antigens could provide protection against serious disease or death during an outbreak of a new strain of influenza for which a vaccine had not yet been developed.

Vical had previously reported that the monovalent vaccine achieved potentially protective levels of antibody responses (H5 hemagglutination inhibition, or HI, titers of at least 40 and at least a four-fold increase from baseline) in at least 50% and up to 67% of evaluable subjects in a 100-subject Phase 1 trial. In the two monovalent vaccine cohorts receiving the highest H5 DNA dose (1 mg), 80% to 100% of the responders had sustained responses through Day 182.

Vical's monovalent vaccine contained a plasmid (a closed loop of DNA) encoding the hemagglutinin (HA) surface protein from the H5N1 influenza virus strain, A/Vietnam/1203/04. It was designed primarily to elicit antibody responses against the H5 protein but could elicit T-cell responses against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus separate plasmids encoding consensus sequences of two highly conserved influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2). The trivalent vaccine was designed to elicit a combination of T-cell and antibody responses against all three proteins. Both vaccines were formulated with the company's Vaxfectin(R) adjuvant, which has demonstrated effectiveness with a variety of DNA vaccines in multiple animal models as well as dose-sparing and immune-enhancing ability in animals with a conventional seasonal influenza vaccine.

RapidResponse(TM) DNA Vaccine Manufacturing Update

New data presented at the current conference indicates that a single injection of a Vaxfectin(R)-formulated influenza vaccine produced by the company's RapidResponse(TM) manufacturing system provided complete protection of mice against challenge with highly lethal doses of H3N2 influenza virus. A dose response was apparent, as mice vaccinated with decreasing doses below a threshold level were afforded decreasing protection. The ratio of Vaxfectin(R) adjuvant to DNA in the vaccine also affected the protective efficacy of the vaccine. In separate tests, the use of alternative PCR primers, an integral part of the RapidResponse(TM) manufacturing process, did not significantly affect the protective efficacy of the resulting product.

The RapidResponse(TM) system is designed to allow extremely rapid and large-scale production of DNA vaccines with low capital requirements. The company is proceeding with the development of the RapidResponse(TM) platform under the second year of grant funding awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs.

Additional information on Vical is available at http://www.vical.com.

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Vaccines Against Avian Flu - AmVac AG Cooperates With National Health Research Institutes In Taiwan

Swiss AmVac AG establishes comprehensive collaboration with the National Health Research Institutes in Taiwan to combat H5N1. H5N1/Influenza A is a flu virus known colloquially as "avian flu". "Avian flu" first occurred in Asia, and was transmitted to humans in a number of cases.

AmVac's CSO Prof. Michel Klein attended the opening ceremony of the pilot plant Vaccine Centre of the National Health Research Institutes in Taiwan. It was resolved to launch a joint collaboration with the aim of developing a new avian flu vaccine. The Taiwanese scientists have decided to use the vaccine adjuvant MALP-2 from AmVac AG for this. The AmVac adjuvant is eminently suitable for absorption through the mucosal membranes. Thus, for the first time, a nasal spray that is safe and at the same time easy to handle, could be feasible as a vaccination product. Through the use of this innovative and highly potential adjuvant, AmVac AG is making a decisive contribution to the development of a novel H5N1 vaccine: the immune system is strengthened effectively and permanently. At the same time, the implementation of the adjuvant makes it possible to reduce the quantity of the antigen used, which is often expensive. Therefore, large quantities of vaccine can be produced more quickly and at a lower price. This is essential, particularly in case of a possible pandemic.

Prof. Michel Klein, CSO of AmVac AG: "Mucosal vaccination via the mucous membranes is the most efficient strategy to elicit both strong local and systemic immunity against respiratory viruses. Intranasal immunization against flu would allow for the production of protective antibody responses at the site of entry of the virus."

Up to now, the development of a flu vaccine spray has been hampered by the lack of a safe adjuvant capable of enhancing strong mucosal immunity. AmVac has acquired exclusive rights to the adjuvant MALP-2 (Macrophage Activating Lipopeptide-2), developed by Prof. C. Guzman at the Helmholtz Center for Infection Research in Braunschweig, for all infectious diseases worldwide. This synthetic, well-tolerated class of adjuvants acts as a "Toll-like" receptor agonist in activating cells of the immune system and thus at central sites in mediation of the immune response. Animal models have already shown strong antibody and cellular responses. Preliminary results in mice have revealed that the pandemic H5N1 flu vaccine combined with MALP-2, elicits flu-specific antibodies following intranasal immunization. The first clinical studies on the H5N1 vaccine will start in 2009, while the implementation of the combination with the adjuvant is planned for the clinical setting in 2011.

AmVac AG

AmVac AG is a biopharmaceutical company situated in Switzerland. The company focuses on the vaccine market with its above-average growth figures. There are two therapeutic vaccines in the pipeline, which are soon to be launched in the fields of gynecology and urology. Further innovative vaccines and technologies are at the development stage. The renowned market research company Frost & Sullivan awarded AmVac AG the coveted prize "Enabling Technology of the Year Award" in 2007.

AmVac AG

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Fate And Effects Of The Drug Tamiflu In The Environment

The research council FORMAS in Sweden has granted 574 000 euro to a new research project that will study the environmental fate and effects of the anti-viral drug Tamiflu on the development on influenza resistance.

Tamiflu is being stockpiled all over the world for use in fighting the next influenza pandemic. However, there are growing signs that influenza viruses may develop resistance to this vital pharmaceutical, because it is routinely prescribed for seasonal influenza.

- This research project is interdisciplinary and will combine studies on the environmental fate of the drug with in vivo studies of the development of Tamiflu resistant viruses say the project leader Björn Olsen at the Department of Medical Sciences Uppsala University.

This research project presents an innovative approach to studying the development of Tamiflu resistance in influenza viruses caused by environmental contamination which is a potential threat to one of our few defences against a future influenza pandemic.

Scientists from Uppsala University, Umeå University and Karolinska Institute will investigate the potential problem from an environmental chemical, virological and infectious diseases aspect.

A wide range of topics will be addressed; studies of the degradation of Tamiflu in sewage treatment plants will be combined with screening of the environmental levels in surface water in Japan. Japan is one of the world's top-per-capita consumers of Tamiflu and it has been estimated that approximately 40% of those that are infected by influenza viruses are treated with Tamiflu. This makes Japan one of the "Hot Spots" in the world and the research project has established collaboration with scientists at Kyoto University and several field sampling campaigns in Japan has been scheduled. Detected environmental levels will then be used in an in vivo Mallard infection model for detailed studies on the development of Tamiflu resistance in low pathogenic avian viruses. This will be combined with a screening study of the occurrence of resistant viruses in faecal samples from wild ducks in the vicinity of Japanese sewage treatment plants.

UPPSALA UNIVERSITET
P.O. Box 256
SE-751 05 Uppsala
http://www.uu.se

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