50% of liver transplantations are due to Hepatitis C infection
High unmet medical need: Prevention of Hepatitis C virus recurrence in liver transplant
DREIEICH, Germany I August 5, 2013 I Biotest AG has achieved another milestone in the development of intravenous hyperimmune globulins: After treatment with virostatics over several weeks the first patient underwent liver transplantation and subsequently was treated with the Hepatitis C hyperimmune globulin CivacirTM in the Phase III clinical trial. CivacirTM, the 10 % Hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a fully owned subsidiary of Biotest AG, has started a clinical trial in North America in patients undergoing liver transplantation as a consequence of Hepatitis C infection.
End-stage liver disease due to hepatitis C virus (HCV) is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by any Hepatitis C viruses which are still circulating in the patient’s body, resulting in a reinfection rate of around 80 % within 4 weeks after transplantation. Currently, there is no approved treatment available to prevent recurrence of the Hepatitis C virus after surgery since current antiviral regimens can not be safely used after surgery due to toxicities, tolerability issues and drug-drug interactions within the first months after transplantation. Approximately 30% of these patients require a second liver transplantation within 5 years.
The aim of this Phase III clinical trial (Study 988) is to evaluate the efficacy and safety as well as the pharmacokinetics of the agent in the HCV transplant population. The study is being conducted in sites in the US and Canada, with a total up to 90 patients to be enrolled.
Market exclusivity for 7 and 10 years after approval in US and EU respectively is ensured by the Orphan Drug designation.
SOURCE: Biotest
Post Views: 51
50% of liver transplantations are due to Hepatitis C infection
High unmet medical need: Prevention of Hepatitis C virus recurrence in liver transplant
DREIEICH, Germany I August 5, 2013 I Biotest AG has achieved another milestone in the development of intravenous hyperimmune globulins: After treatment with virostatics over several weeks the first patient underwent liver transplantation and subsequently was treated with the Hepatitis C hyperimmune globulin CivacirTM in the Phase III clinical trial. CivacirTM, the 10 % Hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a fully owned subsidiary of Biotest AG, has started a clinical trial in North America in patients undergoing liver transplantation as a consequence of Hepatitis C infection.
End-stage liver disease due to hepatitis C virus (HCV) is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by any Hepatitis C viruses which are still circulating in the patient’s body, resulting in a reinfection rate of around 80 % within 4 weeks after transplantation. Currently, there is no approved treatment available to prevent recurrence of the Hepatitis C virus after surgery since current antiviral regimens can not be safely used after surgery due to toxicities, tolerability issues and drug-drug interactions within the first months after transplantation. Approximately 30% of these patients require a second liver transplantation within 5 years.
The aim of this Phase III clinical trial (Study 988) is to evaluate the efficacy and safety as well as the pharmacokinetics of the agent in the HCV transplant population. The study is being conducted in sites in the US and Canada, with a total up to 90 patients to be enrolled.
Market exclusivity for 7 and 10 years after approval in US and EU respectively is ensured by the Orphan Drug designation.
SOURCE: Biotest
Post Views: 51
