Archive for the "Bird Flu / Avian" Category

16
Feb

PuriCore (LSE:PURI), the life sciences company focused on the control of infectious pathogens with its novel, safe antimicrobial technology, announces that its Sterilox Solution has been proven highly effective against pandemic H5N1 avian influenza, a highly contagious and lethal outbreak pathogen. The research showed that Sterilox Solution completely inactivated the H5N1 test strain and passed the US Environmental Protection Agency’s recommended hard-surface disinfection test, which requires two-minutes contact time.

The study conducted by ATS Labs, an independent certified laboratory, tested the virucidal activity of the Sterilox Solution in decontaminating H5N1 avian influenza on hard surfaces. Previous PuriCore studies proved the effectiveness of Sterilox Solution against a common surrogate for the pandemic H5N1 avian influenza strain, the human influenza virus, A/Hong Kong 68 Strain. This new H5N1 research builds upon PuriCore’s earlier microbiological research, including published studies last year showing the effectiveness of the Sterilox Solution against major outbreak pathogens such as norovirus, MRSA, and acinetobacter.

The Sterilox Solution mimics the natural anti-microbial hypochlorous acid produced by the human body to fight pathogens. A wide range of markets that depend upon controlling the spread of infectious pathogens-including food retail and foodservice, hospitality, medical device disinfection, and wound therapy-use Sterilox Systems.

“Pandemic avian influenza remains a concern for healthcare providers, governments, and the general population,” said Greg Bosch, CEO of PuriCore. “These study results further demonstrate that our safe and environmentally friendly Sterilox Solution is highly effective against H5N1 and other dangerous pathogens and can be used in a variety of settings including hotels, hospitals, schools, and cruise ships.”

About PuriCore

PuriCore (LSE:PURI) is a life sciences company focused on developing and commercialising proprietary products that safely, effectively, and naturally kill contagious pathogens. PuriCore’s technology provides a solution to a broad range of markets that depend upon controlling contamination, including food safety in retail and foodservice, medical device disinfection, wound therapy, and hospitality. The Company’s proprietary technology mimics the human body’s production of the natural antimicrobial hypochlorous acid, which is highly effective in killing bacteria, viruses, and fungal spores. Deploying hypochlorous acid solutions as soaks, sprays, mists, and in other forms, PuriCore’s technology is designed to limit the spread of infectious disease, including major public health threats of M. tuberculosis, MRSA, E.coli, Norovirus, Avian Influenza, HIV, Polio Virus, Helicobater pylori, and Legionella. PuriCore is headquartered in Malvern, Pennsylvania, with offices in Stafford, UK.

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ’seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

PuriCore

16
Feb

A sixth mute swan, which was collected on January 21st as part of wild bird surveillance in Dorset, England, has tested positive for H5N1, the virulent bird flu virus strain, reports Defra (Department for the Environment Food and Rural Affairs). Defra added that this sixth confirmation is not a surprise.

Defra informs that the area is currently undergoing an “enhanced surveillance” of wild birds.

Authorities say that current evidence does not point in any way to a spreading of the current outbreak. Nevertheless, poultry keepers in the area have been asked to remain watchful and report any signs of disease at once.

The current outbreak only involves wild birds. No domestic birds have been infected, informs Defra. Samples taken from live swans in the area have all tested negative for H5N1 and other avian influenza virus strains.

As of 3pm on 25 January, the limits imposed on the movement of poultry or other captive birds in the Wild Bird Monitoring Area were lifted, and such movements no longer require a license. Movement restrictions in the Wild Bird Control Area continue.

What is Bird Flu (Avian Influenza)>

Bird flu, or avian influenza, is a disease cause by viruses. It is a contagious disease which infects only birds, and sometimes pigs. The avian influenza viruses attack specific species - they have, on occasions jumped the species barrier and infected people. However, this has been quite rare, and continues to be rare (January 2008).

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).

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

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.

The most dangerous strain of the bird flu virus is called H5N1.

Avian influenza (bird flu): Latest situation (Defra)

Written by - Christian Nordqvist
Copyright: Medical News Today

16
Feb

Recent avian influenza outbreaks in 15 countries demonstrate that the H5N1 virus remains a global threat and requires close monitoring and strong control efforts, FAO said.

Since December 2007, Bangladesh, Benin, China, Egypt, Germany, India, Indonesia, Iran, Israel, Myanmar, Poland, Russia, Ukraine, Turkey and Viet Nam have confirmed new H5N1 outbreaks in poultry stocks. Except for a few cases in wild birds in China, Poland and United Kingdom, most of the confirmed outbreaks occurred in domestic poultry, including chickens, turkeys, geese and ducks.

“Globally, much progress has been achieved in keeping the H5N1 avian influenza virus under control. We are better prepared today to deal with the disease than we were three years ago,” said FAO’s Chief Veterinary Officer Joseph Domenech. “Surveillance, early detection and immediate response have improved and many newly infected countries have managed to eliminate the virus from poultry.”

“But the H5N1 avian influenza crisis is far from over and remains particularly worrying in Indonesia, Bangladesh and Egypt, where the virus has become deeply entrenched despite major control efforts,” Domenech said.

Virus persists

Countries should continue to keep a close eye on the evolving situation. “The virus has not become more contagious to humans but has managed to persist in parts of Asia, Africa and probably Europe. It could still trigger a human influenza pandemic,” Domenech warned.

Commenting on individual countries, FAO’s Chief Veterinary Officer said that India is struggling to keep the worst-ever avian influenza outbreak in West Bengal under control.

Indonesia remains one of the worst affected countries with 31 out of 33 provinces infected since 2004, many heavily. The continuing number of human cases gives cause for concern.

“We have observed that new H5N1 avian influenza virus strains have recently emerged in Indonesia with the possible effect that vaccines currently in use may not be fully protecting poultry against the disease. This requires more investigations and the development of better poultry vaccines,” Domenech said.

The government of Indonesia and FAO, on behalf of the network of OIE/FAO international reference laboratories, are working together in implementing a virus monitoring program to examine the problem more carefully.

In Bangladesh, 21 out of 64 districts have been infected with H5N1 and the situation seems to be worsening. The disease appears to be endemic in the country, surveillance and control campaigns have so far not succeeded in interrupting virus transmission between provinces. FAO is strengthening its presence in Bangladesh to support the government in its efforts to bring the disease under control.

Egypt has stepped up the fight against avian influenza, but the recent outbreaks indicate that control efforts need to be strengthened, Domenech noted.

“The reporting of new outbreaks in poultry, disinfection, culling, movement control and biosecurity on farms and markets remain insufficient and need to be improved. Vaccination campaigns had been generally successful on commercial farms, but not among small-scale producers,” Domenech said.

Following the initial success of vaccination on industrial poultry farms, the control measures may have slackened. The disease was thus given an opportunity to reappear in the industrial sector seemingly resulting in a wider redistribution throughout the country. Domenech also confirmed that the potential change of virus strains should be further investigated. FAO is working closely with the government of Egypt in strengthening all aspects of disease detection, control and communication.

In West Africa, Benin, Ghana, Nigeria and Togo have had outbreaks in 2007. There is a serious risk that the virus becomes well-established in the region, Domenech warned. “Virus circulation in Nigeria could be a potential source of infection for neighboring countries despite intense efforts from the Nigerian government to control the disease in poultry,” he said. FAO continues to work closely with the governments in the region in improving disease control.

In Europe, Germany, Poland, the Russian Federation and the United Kingdom reported new avian influenza outbreaks recently.

“The detection and immediate response in all countries, especially in the European Union, is very effective,” Domenech said. “But we are seeing virus infections in poultry that are not transmitted by wild birds. This raises questions about other ways of virus transmission and potential reservoirs of infection, like in free ranging ducks,” he added.

With FAO’s assistance, more than 50 countries have been able to control and eliminate the disease in poultry.

“Surveillance and immediate control interventions, biosecurity, proper vaccination and culling and the strengthening of veterinary services are key elements for successful H5N1 avian influenza control campaigns,” Domenech said.

http://www.fao.org

16
Feb

NanoViricides, Inc. (OTC BB: NNVC.OB), reported that they are on course with the development of nanoviricides™ drug candidates against highly pathogenic avian influenzas (HPAI) including H5N1 bird flu, and common influenza. “We are now ready to begin animal studies on H5N1 at a renowned federal agency,” said Dr. Eugene Seymour, MD, MPH, CEO of the Company. Earlier, the Company had delayed these studies in search of suitable facilities. The work is expected to begin once the contracts are finalized.

Bird Flu H5N1 continues to spread over ever-widening geographic regions and is a major cause of concern for potential pandemic influenza, according to the WHO. This year so far bird flu has spread into six districts in West Bengal, India, causing 120,000 birds to be culled in just 5 days, and 194,000 people to be screened for bird-flu-like symptoms, reports Times of India on January 21, 2008. A boy died of bird flu in Indonesia, and the H5N1 virus was found as far away as a Ukrainian village of Rivne and also northern part of Iran, reports Voice of America. Various research articles have appeared which make researchers fear the virus could mutate and become significantly transmissible between humans.

There are currently no effective treatments against H5N1, or the class of pandemic threatening viruses called HPAI. “The broad-spectrum FluCide™, and the HPAI-specific FluCide-HP™, are designed using the virus’s host cell-binding features that do not change even when the virus mutates,” says Anil R. Diwan, Ph.D., President of the Company. This feature would potentially make these two drugs the best current treatment options for development, says the Company. Vaccines and Antibodies could lose effectiveness due to mutations. H5N1 resistance to Tamiflu® is well known, and resistance against other existing same-class (neuraminidase inhibitor) drugs such as peramivir and possibly Relenza® could occur due to virus mutations.

About NanoViricides

NanoViricides, Inc. is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company’s novel nanoviricide™ class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H5N1 bird flu, seasonal influenza, HIV, hepatitis C, rabies, and dengue fever, among others.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of the company to be different from those expressed or implied including the success of the Company’s research and development efforts, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process, described in the “Management’s Discussion and Analysis” section of the Company’s Form 10-KSB and other reports and filings with the Securities and Exchange Commission.

NanoViricides

16
Feb

eFoodSafety.com, Inc.’s (OTCBB: EFSF) representatives will attend the Bangkok International Conference on Avian Influenza 2008, Integration from Knowledge to Control in Bangkok from January 23-25. The conference, organized by the National Center for Genetic Engineering and Biotechnology (BIOTEC), the National Science and Technology Development Agency (NSTDA), and other related organizations, aims to provide an international forum for scientific experts and scientists to discuss avian influenza (bird flu) and to facilitate international collaboration to mitigate threats from this disease.

eFoodSafety’s CitroxinTM is currently undergoing testing at Chulalongkorn University, Thailand, on a chick embryo model, for the product’s ability to safely and effectively eradicate the most virulent form of the bird flu, the H5N1 virus. Chulalongkorn University is one of only a few labs in Asia used by the U.S. Centers of Disease Control to conduct research on treatments of H5N1.

“We are looking forward to attending and participating in this important conference, which addresses such a pertinent health concern not only as it applies to the general population, but also as is applies to eFoodSafety,” says Timothy Matula, Director and Corporate Secretary of eFoodSafety. “This is an opportune time to meet with industry experts and share ideas about how to tackle this harmful disease.”

About eFoodSafety.com

eFoodsafety.com, Inc., based in Scottsdale, Arizona, is dedicated to improving health conditions around the world through its innovative technologies. The company’s Knock-Out Technologies, Ltd. subsidiary has developed an environmentally safe sporicidal product formulated entirely of food-grade components that eradicates anthrax and a germicidal product, Citroxin™ (formerly named Big Six Plus) - EPA Reg. No. 82723-1 that kills six major bacteria: E-coli, Listeria, Pseudomonas, Salmonella, Staphylococcus, and Streptococcus, Avian Influenza, and Black Mold. The sporicidal product has completed its final efficacy laboratory study requisite for EPA registration. In the study, it eradicated both Clostridium Sporogenes and Bacillus Subtilis with 100% efficacy on both hard and porous surfaces. The OraPhyte™ product, which has been tested and shown to be effective at eradicating nematodes by the U.S. Department of Agriculture, is currently at three major universities with outstanding Agricultural Departments undergoing crop-specific research.

The company’s Cinnergen™ is a clinically-studied, non-prescription liquid whole food nutritional supplement that promotes healthy glucose metabolism, is available for sale at (http://www.cinnergen.com) and through national retailers; its Cinnechol™ is a multi-faceted nutritional supplement specifically designed to naturally reduce total cholesterol levels without causing any side effects. The company has entered into a joint venture agreement with CK41 Direct, Inc. to launch the PurEffect™ anti-acne skin care system.

The company’s iBoost, Inc. subsidiary is the distributor of the Immune Boost Bar™, a non-dairy, no refined sugar, all-natural and comprehensive multi-nutrient product that helps fortify the body’s immune system. The product contains Citroxin™, eFoodSafety’s proprietary all natural supplement proven effective in fighting several types of harmful bacteria, and forty active compounds that assist with enhancing immunity, detoxification, cleansing, and metabolic efficiency. The Immune Boost Bar™ is available in three delicious flavors: chocolate, oatmeal-raisin, mint and peanut butter and can be purchased at http://www.immuneboost.com.

The company’s MedElite, Inc. subsidiary distributes clinically proven products to physicians who then prescribe the products for their patients. It is the owner of the Talsyn™-CI/bid Scar Cream, a product that has been clinically proven to facilitate and improve the appearance, redness and strength of scars (http://www.talsyn.com), as well as seven (7) other products in the Talsyn™ line.

Safe Harbor Forward-Looking Statements

Statements contained in this release that are not strictly historical are “forward-looking statements.” Such forward-looking statements are sometimes identified by words such as “intends,” “anticipates,” “believes,” “expects” and “hopes.” The forward-looking statements are made based on information available as of the date hereof, and the Company assumes no obligation to update such forward-looking statements. Editors and investors are cautioned that such forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ materially from those in these forward-looking statements. Such risks and uncertainties include but are not limited to demand for the Company’s products and services, our ability to continue to develop markets, general economic conditions, our ability to secure additional financing for the Company and other factors that may be more fully described in reports to shareholders and periodic filings with the Securities and Exchange Commission.

http://www.efoodsafety.com

16
Feb

Aethlon Medical, Inc. (OTCBB: AEMD), a pioneer in developing therapeutic devices for infectious disease, disclosed that researchers have demonstrated the effectiveness of the Aethlon Hemopurifier® in capturing the highly-fatal H5N1 strain of the Avian Flu Virus (Bird Flu). In pre-clinical studies, high concentrations of H5N1 flu virus (approximately 3 million flu virus/ml) were observed to be rapidly depleted from cell culture fluids when circulated through the Hemopurifier®. The study data indicated that during a six-hour testing period, the Hemopurifier® removed up to 99.4 percent of infectious H5N1 flu virus. Verification of viral capture was documented by both real-time PCR and conventional plaque assay (TCID 50) measurements.

“The data provides real hope for a post-infection treatment against pandemic influenza and further reinforces the ability of our Hemopurifier® to address a broad spectrum of viral conditions,” stated James A. Joyce, Chairman and CEO of Aethlon Medical. “Additionally, it appears possible that the use of the Hemopurifier® could open the door for drugs previously considered incapable of providing clinical benefit as a stand-alone therapy.”

The Aethlon Hemopurifier® is a medical device designed for the single-use removal of infectious viral pathogens from blood. The device, which augments the natural immune response of clearing infectious viruses and toxins before cell and organ infection, is positioned to fill a void in treating drug- and vaccine-resistant infectious diseases. In order to further support the use of the Hemopurifier® as a broad-spectrum treatment countermeasure against bioterror and pandemic threats in the United States, Aethlon will include this new data in a forthcoming submission to the U.S. Department of Health and Human Services (HHS) and the newly established Biomedical Advanced Research and Development Authority (BARDA). Based on the significance of the H5N1 data and the continued demonstration of safety in human studies, Aethlon may on a limited basis provide the Hemopurifier® to countries that request the Hemopurifier® as a treatment option for infected citizens. Researchers at the Battelle Biomedical Research Center conducted the H5N1 studies.

It is feared that the H5N1 strain of avian influenza virus, whose mortality rate in infected humans exceeds 60 percent, will spark a global epidemic should it evolve to allow for an efficient spread of host-to-host infections in humans. The recent discovery that H5N1 avian influenza virus can spread via the bloodstream to organs and other regions of the body typically not attacked by influenza viruses explains, in part, the high virulence of H5N1 infection and why it remains a serious pandemic threat. The ability of H5N1 virus to proliferate in blood represents a causative effect for triggering hypercytokinemia (cytokine storm), a direct parallel to the Spanish Flu of 1918, which reportedly killed up to 40 million people within 20 months. Though governments and health agencies are stockpiling antiviral drugs to treat influenza, these therapies have yet to demonstrate effectiveness against human H5N1 infection. A further complication to drug treatment has arisen from the clinical observation that drug absorption appears impaired in severely ill H5N1 patients, and in H5N1 patients with gastrointestinal symptoms.

Researchers believe the removal of circulating H5N1 hemagglutinin, a surface protein that is deleterious to the host and immune system, combined with the removal of infectious H5N1 virus would be clinically beneficial to infected patients. Corresponding to this belief, the Hemopurifier® targets the rapid removal of both infectious H5N1 virus and immunosuppressive H5N1 hamagglutinin from circulation. As a result, Aethlon believes the Hemopurifier® is positioned to benefit infected patients, both as a stand-alone therapeutic, and as an adjunct treatment able to improve the clinical benefit of other candidate therapies.

About Battelle Biomedical Research Center

Battelle Biomedical Research Center is a research group in the National Security Global Division of Battelle Memorial Institute, an organization that provides solutions to some of the world’s most important challenges through its three global businesses: National Security, Energy Science and Technology, and Health and Life Sciences. Battelle is the world’s largest independent research and development organization with technology contributions that find their way into hundreds of commercial products each year. Conducting multi-billion dollars in global R&D annually, Battelle oversees over 20,000 employees in more than 120 locations worldwide, including five national laboratories that Battelle manages or co-manages for the U.S. Department of Energy. Battelle was recently approved by the Department of Health and Human Services (HHS) under the Select Agent Programs of the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to carry out studies on highly pathogenic avian influenza, including the H5N1 strain. Battelle was established in 1929 as a non-profit charitable trust and is headquartered in Columbus, Ohio. For more information, visit http://www.battelle.org.

About Aethlon Medical

Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® addresses the largest opportunity in infectious disease, the treatment of drug- and vaccine-resistant viruses. The Hemopurifier® is a single use extracorporeal device that converges hollow-fiber filtration technology with immobilized affinity agents to capture viruses and soluble glycoproteins from the blood. The device has been designed to mimic the natural immune response of clearing infectious viruses and immunosuppressive proteins from circulation. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier® are being conducted with researchers at the Government of India’s National Institute of Virology (NIV), The Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the Hemopurifier® in a 24-treatment human study and is now conducting follow-on safety studies at the Fortis Hospital in Delhi, India. The Company has also submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) related to advancing the Hemopurifier® as a broad-spectrum treatment countermeasure against category “A” bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier® technology can be accessed online at http://www.aethlonmedical.com.

Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company’s ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company’s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company’s Securities and Exchange Commission filings.

Aethlon Medical

16
Feb

Progress in the planned culling of 400,000 poultry following recent outbreaks of bird flu in the state of Bengal in India are being hampered by farmers and poultry owners reluctant to co-operate with animal husbandry teams sent to carry out the task.

According to a Reuters news agency photographer, some villagers at the centre of the outbreak said their ducks and chickens were not infected and were refusing to hand them over. Others have released their birds, making it hard for the culling teams to catch and destroy them.

Reporting from Calcutta, the Associated Press news agency said that over 50,000 birds have been culled in the third day of the planned 7 day operation to contain the spread of the virus which has hit districts in West Bengal, and which the World Health Organization has described as the worst bird flu outbreak in India to date.

The state government of Bengal said earlier this week they were planning to cull 400,000 poultry birds in a 5 to 10 kilometre radius of areas affected by the latest outbreak of H5N1 bird flu.

The areas affected are the Birbhum and Dakshin Dinajpur Districts of West Bengal.

According to the Times of India, Chief Minister Buddhadeb Bhattacharjee told the press that:

“We will have to kill four lakh birds in the affected districts. For this, we have decided to increase the strength of the culling teams.”

A lakh is a term used by officials in India to denote 100,000.

The decision was made following a meeting between officials from the Animal Resourcers and Development Department, the Health Department and the Central Livestock Commission.

The birds that died in the outbreaks were carrying the H5N1 strain of bird flu. This was confirmed in a letter from the Ministry of Agriculture, Department of Animal Husbandry, Dairying and Fisheries to the government of West Bengal, dated 15th January.

Samples from birds in the districts affected were sent to two labs for testing: the High Security Animal Disease Laboratory (HSADL) in Bhopal and the National Institute of Virology (NIV) in Pune. At least one sample from each of the two districts tested “positive for H5N1 strain of Avian Influenza in poultry”. The results of the other samples will be sent as soon as they are ready, said the letter.

Bhattacharjee said that a sub-division of Birbhum, called Rampurhat, was the worst affected, followed by Balurghat in West Dinajpur.

The culling is being carried out by 60 teams of animal husbandry workers, accompanied by medical staff to see if any people have been infected.

Local hospitals are on standby with isolation wards ready to receive any patients affected by the outbreak, as are teaching hospitals in nearby districts, said the Chief Minister.

So far India has reported no human cases of H5N1 bird flu.

The state government of Bengal has set aside 30 million rupees for compensation, said the Minister. This is about 750,000 US dollars, nearly 2 dollars a bird.

In terms of damage to business however, compensation per bird is no comparison the the fact poultry owners will effectively not be trading for at least three months, which together with reports that sales of chicken are down to half the normal trading level in the region, will cause severe hardship to many small farmers and poultry owners.

Meanwhile in Bangladesh, the Ministry of Fisheries and Livestock has reported that nearly 300,000 poultry have been culled in over 93 farms in 22 districts, following an outbreak of H5 avian flu on 75 of the farms. No human cases have been reported they told the WHO.

Click here for WHO in India.

Sources: Times of India, Government of India Ministry of Agriculture website, WHO, Reuters, Associated Press.

Written by: Catharine Paddock
Copyright: Medical News Today

16
Feb

Juvaris BioTherapeutics, Inc. announced that The Centers for Disease Control and Prevention and Juvaris BioTherapeutics, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) for the evaluation of a JVRS-100 adjuvanted H5N1 pandemic influenza vaccine. The ability of JVRS-100 to aid in the induction of a protective antibody response to the H5N1 vaccine at low doses of vaccine will be confirmed. This collaborative study will determine if the use of the Juvaris JVRS-100 adjuvant will extend the limited supply of H5N1 vaccines in the event of a pandemic.

In preparation for the possibility of an influenza pandemic caused by an H5N1 avian influenza virus that has obtained the ability to be easily transmitted from person to person, several strains of H5N1 viruses have been used to prepare killed-virus vaccines. Vaccine trials in people testing the immunogenicity of these pre-pandemic vaccines have shown that high vaccine doses are required to produce an antibody response that is believed to be protective. In order to lower the dose of vaccine and extend the supply of available vaccine, a number of immune boosters known as adjuvants are being tested.

“Although the principal commercial value of JVRS-100 will be as a mono-immunotherapy, we are pleased to enter into this CRADA with CDC for testing of the JVRS-100 as an adjuvant for potential extension of the current supply of H5N1 vaccine,” said Martin D. Cleary, Co-founder, President and CEO of Juvaris. “In preclinical studies using seasonal influenza vaccine our adjuvant can decrease the amount of vaccine necessary to induce protective antibody immunity up to fifty-fold, which would be beneficial in case of limited vaccine supply during an influenza pandemic. Furthermore, preclinical experiments with inactivated virus have shown greater cross-protection when our adjuvant is used.”

About Juvaris

Juvaris BioTherapeutics was created in 2003 to develop an immunotherapeutic product platform for the treatment of infectious diseases and cancers using lipid-DNA complexes. Cationic lipids are formulated with non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a lipid-DNA complex, which as a single product will have utility in multiple infectious disease and cancer applications. The JuvImmune product has been shown to be at least 50-times more potent at triggering innate immune activation and interferon release than current immune stimulants.

When combined with disease-specific antigens, the technology creates JuvaVax vaccines capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes (CTL). Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic settings in a variety of mammals including rodents, rabbits, cats, dogs and non-human primates. This platform provides the opportunity to develop many disease-specific immunotherapy products, for which there are significant unmet medical needs.

The Company recently completed a Series A financing with Kleiner Perkins Caufield & Byers as the sole investor. It plans to start up to four clinical studies in 2008. The first will be a prophylactic vaccine for Influenza A, the second a therapy for chronic Hepatitis B, the third for chronic Hepatitis C and a fourth for Acute Myelogenous Leukemia (AML).

Juvaris BioTherapeutics, Inc.
http://www.juvaris.com

16
Feb

Carrington Laboratories, Inc. (OTC Bulletin Board: CARN) announced that its wholly owned DelSite Biotechnologies, Inc. subsidiary has successfully completed preclinical toxicology studies of its GelVac(TM) nasal powder influenza vaccine under FDA-reviewed protocols. Successful toxicology studies in two animal models using the H5N1 (bird flu) antigen were required in order to proceed with a planned Phase I clinical trial later this year. The bird flu antigen used in these preclinical studies was from a non-egg-based source.

This vaccine candidate is believed to be the only nasal powder vaccine under development that, if approved, could be shipped without refrigeration to peoples’ homes and self-administered in the event of a pandemic outbreak of avian bird flu.

The toxicology studies were conducted at Charles River Laboratories, Preclinical Services, Wilmington, MA, a contract research organization well known for its work in preclinical studies of viral antigens. After administering one or two doses to test subjects at the highest dose tested, testing results showed the vaccine is safe and nontoxic and thus established the base for moving into the Phase I clinical study of the vaccine in humans subject to normal FDA regulatory procedures.

Separately, DelSite successfully completed its second pre-IND meeting with the FDA last November, which was held at the request of the FDA to discuss and clarify protocols related to the use of the H5N1 antigen. Previously, a Phase I human safety study on the GelVac(TM) platform (without an antigen) showed the delivery platform was safe and well tolerated. The GelVac(TM) nasal powder formulation with the H5N1 vaccine antigen is planned to enter a Phase I study in 2008.

“The successful completion of these preclinical toxicology studies is a major milestone in developing this H5N1 vaccine based on our GelVac(TM) nasal powder technology,” stated Carlton E. Turner, PhD, president and CEO of Carrington. “In addition, the completion of the second pre-IND meeting has clearly laid out the development path toward clinical studies. These developments further demonstrate the feasibility of the GelVac(TM) nasal powder platform technology which can greatly expand the availability and coverage of vaccines with its distinct advantages over current liquid needle-based and nasal mist formulation technologies.”

Dr. Turner added, “There is a true paradigm shift underway in vaccines from the classical needle delivery to a more user-friendly application. FluMist(R) by MedImmune started the shift, and I believe our nasal powder technology will complete the shift to a patient-friendly vaccination formulation and will open up markets that cannot be served by current vaccines systems.”

Dr. Yawei Ni, chief scientific officer of DelSite, added, “Our nasal powder vaccine platform has been shown to work with many antigens, is stable at room temperature, requires no needles, no preservatives, and no cold storage, and can be shipped free of the restrictive cold chain distribution systems associated with vaccines. Moreover, our system is particularly well suited for influenza pandemic preparedness, bio-defense applications, and vaccine coverage in areas lacking basic infrastructures.”

GelVac(TM) powder platform possesses other distinct, practical features. The GelSite(R) polymer used in the formulation is derived from a natural source and is stable over four years at room temperature. The polymer binds to and stabilized proteins and peptides. An influenza vaccine incorporating a, non-egg based, H1N1 antigen in the GelVac(TM) formulation has been stable at ambient room temperature for 36 months.

The nasal cavity is increasingly recognized as the ideal immunization route since most infectious diseases enter the body through mucosal surfaces such as those found in the nasal cavity, the lungs, and the intestines. Nasal immunization not only induces a systemic response, but also induces mucosal response, providing protection at the entry point. GelVac(TM) is a novel in- situ gelling powder formulation for nasal delivery. The GelSite(R) polymer enables in-situ gelling of the vaccine powder, which changes into gel particles upon exposure to nasal fluids present in the nasal passage. This gel adheres to the mucosal lining and provides prolonged residence time and sustained antigen release that, in turn, increase antigen delivery.

About DelSite

Carrington’s wholly owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs and vaccines. DelSite is currently developing a nasal powder vaccine using its GelVac(TM) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from NIAID (National Institute of Allergy and Infectious Diseases) of NIH (National Institutes of Health) under the Department of Health and Human Services.

A Drug Master File (DMF) has been filed with the FDA for GelSite(R) polymer which may be made in kilogram quantities under cGMP guidelines in an ISO-certified facility.

About Carrington

Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company currently utilizing naturally-occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. Carrington’s DelSite Biotechnologies subsidiary is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs. Carrington’s technology is protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. For more information, visit http://www.carringtonlabs.com.

Certain statements in this release concerning Carrington may be forward-looking. Actual events will be dependent upon a number of factors and risks including, but not limited to: subsequent changes in plans by the Company’s management; delays or problems in formulation, manufacturing, distribution, production and/or launch of new finished products; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company’s filings with the Securities & Exchange Commission.

Carrington Laboratories, Inc.
http://www.carringtonlabs.com

16
Feb

Anadis Limited (ASX:ANX; OTC: ANDIY), announced major progress in its anti-flu virus antibody program. The milk- derived anti-flu virus antibodies are all-natural and will provide immediate-acting immune enhancement once deposited topically on mucosal surfaces that come in contact with the influenza virus. Results from human trials are anticipated within 18 months. Addressing both seasonal and avian influenza (bird flu) virus strains, Anadis plans to introduce products using these antibodies (Flubodies) into the market within 2-3 years. This decision follows several successful animal trials with mice, conducted by Anadis and an internationally-recognized influenza research group at the University of Melbourne led by Professor Lorena Brown, using recognized pathways for development of anti-avian flu virus treatments. The dairy derived anti-flu virus antibody significantly decreased disease mortality and were significantly interrupting the disease process after challenges with lethal doses of virus. Anadis prototype milk-derived hyperimmune antibody preparation (”flubody”) improved the survival rate of infected mice (exposed to lethal flu) from 0% in non-treated mice to up to 60% in treated mice. In other trials, it was shown that the progress of disease could be delayed for days with a single application of the prototype formulation.

“This series of new preclinical tests gives us the comfort level to accelerate and the commercialization of our revolutionary Flubody approach for halting viral spread, utilizing our patent pending antibody formulations to provide immediate acting immunity,” said Dr Zeil Rosenberg, Anadis CEO. “Antibody and other protein-based solutions represent the next generation in the fight against influenza and Anadis, with its rapid development effort and extremely low manufacturing cost for harvesting antibodies, is well-positioned to benefit from this trend.” Influenza affects 15-60 million people in the United States each year, causing an estimated 44,000 deaths and 186,000 hospitalizations annually. Pandemic influenza has occurred three times over the last century. The 1918 outbreak alone killed more than 40 million people worldwide. Avian influenza (bird flu) is a lethal influenza strain that has created worldwide concern because its infection can be transferred among humans. The mortality rate among humans exceeds 50%.

Dr. Oren Fuerst, VP of Business Development of the company said: “Benefiting from our years of experience in the harvesting of polyclonal antibodies and other fractions of dairy derived immune milk (colostrum), we aim to be first to market with an effective and patented formulation for both the routine and avian flu markets. With our unique approach, we plan to become world leaders in the influenza market that today already exceeds $5 billion worldwide.”

Anadis Limited (ASX: ANX; OTC: ANDIY) is a biopharmaceutical company focused on antigen-primed, dairy-derived health products. Anadis’ proprietary, rapid manufacturing technology has enabled it to develop a product pipeline of polyclonal antibody-based solutions to a range of important infectious and immune-mediated diseases. The all-natural colostrum-derived platform, and its regulatory classification as GRAS (Generally Regarded as Safe) when administered orally, allows for a significantly shorter time-frame from bench to market compared with typical biotechnology products. The platform also possesses dramatically lower manufacturing costs and higher scalability compared to typical antibody-based solutions. Anadis is addressing existing market opportunities sized in excess of US$30 billion. Leveraging a technology platform that has been carefully developed over a decade, the company expects to become the leading provider of proprietary polyclonal antibody-based solutions worldwide.

Anadis Limited