Dr. Jiahai Lu, from the School of Public Health, Sun Yat-sen University in Guangzhou, China, has published extensively in the field of avian influenza, and has been researching the breakthrough compound StatC for the past two years on behalf of Canopus Biopharma (OTCPK:CBIA), a Los Angeles corporation that discovered and patented the potential of this antiviral candidate.
"The global distribution of the highly pathogenic H5N1 avian influenza has caused the World Health Organization to show its profound concern regarding the possibility of the virus spreading from human to human in the future," stated Dr. Lu. "Furthermore, the development of resistance to two approved anti-influenza drugs, oseltamivir (Tamiflu®) and zanamivir (Relenza®), as well as the lack of adequate vaccines has increased the need of developing new antiviral drugs. Consequently, I am delighted to be involved in the preclinical research stage of this innovative antiviral candidate, and look forward to continuing our successful collaboration with Canopus Biopharma in this area."
"The results of our study suggest that a statin/caffeine combination may be a viable treatment or preventative against influenza virus infections," said Patrick Prendergast, Chief Executive Officer, Canopus BioPharma. "The synergistic statin/caffeine combination investigated through the study effectively lessened lung damage and inhibited viral replication in animal models for the H5N1, H3N2, and H1N1 influenza viruses.
"With these findings, we will aggressively continue the development of StatC," he said. "It's clear that there's significant global need for a superior, low-cost and plentiful alternative in the fight against various forms of increasingly harmful influenzas."
Dr. Lu and his colleagues have conducted extensive animal studies with StatC against three influenza strains, H5N1 (avian influenza, bird flu), H1N1 (Spanish influenza) and H3N2 (Hong Kong influenza). StatC is a combination of two FDA approved compounds which have been re-formulated by Canopus BioPharma for the prevention and treatment of Influenza. Oseltamivir and ribavirin were used as positive controls in this study. In the H5N1 model, StatC prevented and relieved the symptoms of H5N1 infection, inhibited lung damage and H5N1 virus replication in the lungs of mice, and was as effective as oseltamivir in both prevention and therapy models. There were no animals with positive viral detection in the groups nasally administered with StatC. Likewise, StatC demonstrated similar results against the H3N2 and H1N1 viruses.
"We are encouraged with these findings," said Dr. Lu. "It is possible that higher doses of statin than those used in this study may result in even greater efficacy. StatC also appeared to be more effective when administered preventatively." With current positive results, Canopus BioPharma is looking to form a co-development agreement or licensing arrangements with pharmaceutical companies and Government health authorities interested in providing more economical and universal treatment for their populations in the event of a pandemic.
At the forefront of influenza research in Guangzhou, China, Dr. Lu is perfectly placed to further investigate the synergistic properties of the statin/caffeine combination. "We are also motivated at the potential of this compound in comparison with other currently available anti-influenza medications. It's clear that there is significant global need for a superior, low cost and plentiful alternative in the fight against influenza." added Dr. Lu. While StatC has proven to be highly efficacious against the most virulent strains of influenza, it must be noted that StatC is also extremely effective against non-fatal, human forms of the virus that occur annually.
Approved by the Food and Drug Administration, oseltamivir (Tamiflu) is the leading prescription medicine approved for the prevention and treatment of influenza in adults and children. 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's strategy for developing StatC includes continued animal testing in partnership with its extensive network of American and Chinese based research laboratories. The next step involves a ferret animal model using a lethal strain of influenza to examine the efficacy of StatC. Once completed, Canopus BioPharma's preclinical results will then satisfy the FDA's Animal Efficacy Rule and will make StatC available for Government stockpiling for use in the case of a pandemic.
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Statc™ -- Trial, Overview And Fact Sheet
- Every year, on average, 5 percent to 20 percent of the population is affected by influenza; more than 200,000 people are hospitalized from flu complications, and some 36,000 people die from the flu.
- The global market demand for influenza treatments will expand to 370 million doses, with a market value of approximately $3.7 billion by 2010.
- Due to the high lethality and virulence of "Avian flu" HPAI A (H5N1), the virus is currently the world's largest pandemic threat.
- Through March 2007, the total number of confirmed human cases of Avian flu was 284, of which 169 (59 percent) were fatal.
- The H1N1 virus, also known as the Spanish flu, was responsible for the largest pandemic to date, while H3N2 - the Hong Kong flu - is a major cause of today's seasonal human flu.
What is StatC™?
- StatC™ is a "super generic" statin/caffeine combination drug with a unique synergistic mechanism of action.
- Super generics are FDA-approved but reformulated drugs used for clinical indications that differ from the drug's original purpose.
- StatC ™ is a combination of two of the world's most widely consumed drugs - statins and caffeine - and possesses no known toxicity at the dose required for efficacy.
- StatC™ was developed and reformulated by Canopus BioPharma, Inc. of Los Angeles.
- Canopus' pre-clinical data shows inhibition of three strains of influenza with StatC™
-- H5N1 (Avian flu)
-- H3N2 (Hong Kong flu)
-- H1N1 (Spanish flu)
- StatC™ reduces the viral load significantly and is as effective as TAMIFLU. TAMILFU is the only drug currently recommended for treatment and prevention of Avian flu. 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.
- Initiated by Canopus BioPharma, Inc., the principal investigator for the study was Professor Jiahai Lu -- a specialist in the development of novel anti-flu drugs at the Sun Yat-Sen University in Guangzhou, China.
- The research objective of this study was:
-- Compare the StatC™ compound with oseltamivir (TAMIFLU), ribavirin and equine anti-H5N1 IgG, against H5N1 (Avian flu), H3N2 (Hong Kong flu), and H1N1 (Spanish flu) virus infection in a mouse model.
Key Findings From StatC™ Study
- Particularly at the higher dose of statin 50 µg/caffeine 200 µg and when administered preventatively, the statin/caffeine compound effectively inhibited lung damage, as well as inhibiting H5N1, H3N2, and H1N1 viral replication in the lung.
- It is possible that higher doses of statin (>50 μg) may result in even greater efficacy, as the effect of 50 μg statin/200 μg caffeine on these outcomes was significantly better than statin 25 μg/200 μg caffeine.
- The statin/caffeine combination appeared to be more effective when administered preventatively rather than as treatment, suggesting that a statin/caffeine combination may be a viable treatment or prophylactic against influenza virus infections.
- In a H3N2 animal model, no influenza virus was present in the StatC™ treated groups.
- The histopathology results also indicated less lung pathology damage in the StatC™ preventative group, when compared to TAMIFLU.
- In a H5N1 animal model, the StatC™ treated groups showed a reduction in viral titre, equal to that of TAMIFLU.
- StatC™ groups also showed a greater reduction in inflammation of lung tissue, the principal cause of hospitalization and death from influenza infection.
- In the H1N1 animal model, StatC™ prevented lung damage better than TAMIFLU, in the prophylactic group.
About Canopus BioPharma, Inc.
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 R&D 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. The company is focused on providing affordable therapeutic and diagnostic benefits and pharmaceutical excellence to patients and healthcare professionals worldwide. Canopus maintains staff in Australia, South Africa, Ireland and the USA.
Canopus BioPharma, Inc.