Canopus Biopharma (PK) (USOTC:CBIA)
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From Oct 2019 to Oct 2024
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.