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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