01 August 2007
Canopus BioPharma's StatC Drug Shows Superior Results for Treatment of Avian Flu and Other Influenzas
Aug 1, 2007: Canopus BioPharma, Inc. (OTC: CBIA), a biotechnology company developing pharmaceutical products and assay methods for patients suffering from infectious disease, bio-terrorism, cancer, and addiction, announced today groundbreaking results in animal trials for its drug candidate StatC against Avian Flu, Spanish Flu and Hong Kong Flu strains. Studies performed using StatC have shown results which are superior to TAMIFLU, the leading influenza antiviral (estimated market size in excess of $2.2 billion) drug distributed in the United States by Roche Pharmaceuticals. Specifically, the research found that Canopus BioPharma's StatC is superior to TAMIFLU in preventing influenza in three different strains of the virus in mouse models.
In extensive animal studies conducted for Canopus BioPharma, it was demonstrated that H5N1 viral load in the lungs of infected mice administered with StatC intranasally as a preventation was more effective than TAMIFLU. Demonstrating significant improvement, 30% of StatC-treated lung samples had virus detected in comparison to 50% of TAMIFLU treated samples. Histopathology which measures lung damage due to influenza infection demonstrated in these studies that mice treated with StatC had statistically significant reduction in lung damage as compared to the group treated with TAMIFLU.
According to the Center for Disease Control (CDC), the flu is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness, and at times can lead to death. The best way to prevent the flu is by getting an annual flu vaccination. Every year in the United States, on average 5% to 20% of the population gets the flu, more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu. Companies developing drugs to compete with TAMIFLU in the fight against various influenzas such as Avian Flu (H5N1) and other strains include Canopus BioPharma of the U.S. and Ireland, GlaxoSmithKline of England, Novartis AG of Switzerland, Novavax, Inc. of the U.S., Sanofi Pasteur of France, and Sinovac Biotech Ltd of China, among others.
Approved by the Food and Drug Administration, TAMIFLU is the leading doctor-prescribed flu medicine (antiviral) and is approved for the prevention and treatment of influenza in adults and children from the age of one. To date, Roche has filled orders from the U.S. federal government and states for 43.7 million TAMIFLU treatment courses. Datamonitor, the world's leading provider of online data, analytic and forecasting platforms for key vertical sectors, forecasts that global market demand for influenza treatments will expand to 370 million doses and a market value of approximately $3.7 billion by 2010.
Canopus BioPharma plans to enter the influenza market with its drug candidate StatC and has shown promising and more efficacious results than existing treatment standards. In the United Stated, Canopus BioPharma initially proved the StatC formulation was effective in a cotton rat model of influenza virus H3N2. These studies were performed in partnership with Virion Systems Inc. of Rockville, MD.
The discovery by Canopus BioPharma brings statins into the arena as a new antiviral for influenza by combining any prescription statin with another FDA-approved molecule readily used by humans which in combination work synergistically to produce an antiviral effect that prevents influenza infection. Furthermore, as compared to TAMIFLU treatment, StatC results show a greater reduction in inflammation of lung tissue, the principle cause of hospitalization and death from influenza infection. The strains tested in animal models by Prof. Jiahai Lu, an internationally recognized published expert on H5N1 animal model studies from the School of Public Health, Sun Yat-sen University in Guangzhou, China, were H5N1 (Avian Flu), H3N2 (Hong Kong Flu) and H1N1 (Spanish Flu).
Providing further international validation, StatC was confirmed in-vitro in culture against H5N1 (Avian Flu) under the guidance of Prof. Paul Chan at The Prince of Wales Hospital, Hong Kong, China. Prof. Chan is a respected research professional and one of the few in the world with experience in confirmatory H5N1 animal model studies. A unique process employed by Prof. Chan is the study of cultures and tests against an H5N1 virus isolated from bird flu infected patient. H5N1 is considered to be a more difficult flu strain to test in a controlled clinical environment because most laboratories are not equipped to handle an airborne virus which is classified as "deadly."
Through March 2007, the total number of confirmed human cases of Avian Flu had amounted to 284, of which 169 (59%) were fatal. Although TAMILFU is the only drug currently recommended for treatment and prevention of Avian Flu, the development of other antiviral drugs against the Avian Flu virus is urgently required in the light of the dire current statistics. Furthermore, findings published in the New England Journal of Medicine noted that four out of eight patients treated in Vietnam for bird flu infections had died despite the use of TAMIFLU. (NEJM, December 22, 2005; 353(25):2667-72. "Oseltamivir (TAMIFLU) resistance during treatment of influenza A (H5N1) infection.")
"Flu prevention and reduced lung tissue inflammation using the StatC drug in our study group was demonstrably superior as compared against results for TAMIFLU," stated Patrick Prendergast, Chief Executive Officer of Canopus BioPharma. "The StatC formulation has proved superior to TAMIFLU in mouse studies carried out in China by Prof. Jiahai Lu and the research results are being prepared for publication. We believe our results will be viewed as an important scientific breakthrough in the global fight to prevent and treat multiple strains of influenza."
For the Hong Kong flu (H3N2), the experiments preformed by Prof. Lu exhibited more successful results for the StatC with no influenza virus present in the StatC treated groups. The histopathology results also indicated that less lung pathology damage was observed in the StatC preventative group when compared to the TAMIFLU.
For the flue strain H1N1 (this flu variant was responsible for the Spanish flu pandemic that killed some 50 million to 100 million people worldwide in 1918 and 1919), Prof. Lu's work also demonstrated that StatC could inhibit the replication of this Influenza strain in the lungs of treated mice and prevent lung damage better than TAMIFLU.
Canopus BioPharma's strategy for developing its StatC drug includes continued animal testing in partnership with its extensive network of European- and Chinese-based biotechnology research laboratories. In addition, a human influenza challenge study will be conducted to compare StatC as a preventative intervention for influenza against other currently available antivirals.
Canopus BioPharma, Inc. (OTC: CBIA) is dedicated to providing the safest, most cost effective and efficacious pharmaceutical products and assay methods to patients suffering from infectious disease, bio-terrorism, cancer, and addiction. With innovative science, proven research and development leadership, and superior products and compounds, Canopus BioPharma has since 2001 been committed to becoming a market trend setter in the new era of healthcare, which is focused on providing affordable therapeutic and diagnostic benefits and pharmaceutical excellence to patients and healthcare professionals worldwide. In addition, the Company is a world leader in the development of novel camelid antibody products to provide unique avenues of progress and improvement in assay methods and monitoring capabilities for physicians, patients and researchers, particularly for food chain protection applications. Canopus maintains staff in Australia, South Africa, Ireland and the USA. Additional information on the Company is available at www.canopusbiopharma.com
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