Working with U.S. Department of Defense, Canopus BioPharma Announces Phase II Human Clinical Trial for Innovative Hepatitis C...

  
    
  
  
    
      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.