Canopus BioPharma's StatC Drug Shows Superior Results for Treatment of Avian Flu and Other Influenzas
August 01 2007 - 12:02PM
Business Wire
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 a 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. With the
exception of historical information contained in this press
release, content herein may contain �forward looking statements�
that are made pursuant to the Safe Harbor Provisions of the Private
Securities Litigation Reform Act of 1995. These statements are
based on management�s current expectations and are subject to
uncertainty and changes in circumstances. In particular, the
Company may not be successful in its efforts commercialize or
attain acceptable clinical results for its products. Investors are
cautioned that forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from the statements made. These factors include general economic
conditions, delays and risks associated with the performance of
contracts and research and development programs, uncertainties as a
result of research and development, consumer and industry
acceptance, litigation and/or court proceedings, regulatory risks
including approval of Food and Drug Administration filings, the
ability to achieve and maintain revenues and profitability in the
Company�s business lines, and other factors discussed in the
Company's filings with the Securities and Exchange Commission.
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