Working with U.S. Department of Defense, Canopus BioPharma Announces Phase II Human Clinical Trial for Innovative Hepatitis C...
05 November 2008 - 12:00AM
Business Wire
Canopus BioPharma, Inc. (OTC:CBIA);(www.canopusbiopharma.com) today
announced that permission has been granted by the U.S. Department
of Defense to initiate a Hepatitis C efficacy and safety human
clinical Phase II trial, testing the patented antiviral drug
CB5300. The 15-patient, Phase II clinical trial will be conducted
at Brooke Army Medical Center in Texas and will be directed by Lt.
Colonel. Stephen Harrison, Ph.D. The study will involve
administering CB5300 orally to individuals with chronic Hepatitis C
who have not previously undergone drug treatment or therapy for the
disease. CB5300 will be administered as a mono-therapy, with
detailed monitoring and reporting of viral load and liver enzymes.
�We are excited to begin the clinical trial with our partners at
the U.S. Department of Defense,� said Patrick T. Prendergast,
Chairman and CEO, Canopus BioPharma. �Our pre-clinical data shows
very promising results, and we expect this clinical trial will
confirm that taking CB5300 translates into a greater quality of
life for those living with Hepatitis C.� CB5300 represents a unique
family of molecules that are non-toxic in nature and are registered
with the FDA as having GRAS (Generally Regarded As Safe) status.
The molecules, which have potent antiviral properties against a
wide range of viruses, were first discovered to be antiviral by
Canopus BioPharma a number of years ago. The company successfully
refined, isolated, and patented the most active molecules as
CB5300. Prior to developing the Phase II trial, Canopus BioPharma
tested CB5300 at the Southern Research Institute in Alabama against
the BVDV Hepatitis (HCV) assay model�the industry accepted standard
laboratory test for anti-HCV activity. The selected CB5300
molecules displayed specific antiviral activity against BVDV and
overall assay performance was validated by the positive control
compound, Recombinant Interferon Alpha, which exhibited the
expected level of antiviral activity. The therapeutic index for
CB5300 was greater than 177, compared to that of the current
prescription interferon alpha for Hepatitis C, which has a
therapeutic index of greater than 55. �There are currently more
than 130 million people infected with Hepatitis C worldwide, and
the annual cost for treatment of Hepatitis C is greater than $2
billion in the US alone,� Prendergast said. With the positive
pre-clinical results and the opportunity to begin a human clinical
trial with the US Department of Defense, Canopus BioPharma is
actively seeking a licensing or co-development partner to assist in
bringing CB5300 to commercialization. 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 in the areas of infectious disease, radiation
protection, 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 a new era of healthcare. 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, initially 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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