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Working with U.S. Department of Defense, Canopus BioPharma Announces Phase II Human Clinical Trial for Innovative Hepatitis C Drug, CB5300

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Working with U.S. Department of Defense, Canopus BioPharma Announces Phase II

Human Clinical Trial for Innovative Hepatitis C Drug, CB5300

From the PharmaLive.com News Archive - Nov. 04, 2008

LOS ANGELES--(BUSINESS WIRE)--Nov 4, 2008 - 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 Army Medical

Center in Texas and will be directed by Lt. Colonel. on, 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 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.

Contact

Media Contact:

Edge Communications, Inc.

Ken Greenberg, 818-990-5001

ken@...

or

Canopus BioPharma, Inc.

Len Rothstein, President

818-980-5008

Fax: 818-980-5088

len@...

Link to comment
Share on other sites

Working with U.S. Department of Defense, Canopus BioPharma Announces Phase II

Human Clinical Trial for Innovative Hepatitis C Drug, CB5300

From the PharmaLive.com News Archive - Nov. 04, 2008

LOS ANGELES--(BUSINESS WIRE)--Nov 4, 2008 - 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 Army Medical

Center in Texas and will be directed by Lt. Colonel. on, 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 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.

Contact

Media Contact:

Edge Communications, Inc.

Ken Greenberg, 818-990-5001

ken@...

or

Canopus BioPharma, Inc.

Len Rothstein, President

818-980-5008

Fax: 818-980-5088

len@...

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