Preliminary clinical results suggest that Civacir® reduces the hepatitis C virus recurrence rate after liver transplantation in an impressive way to 5% (1 out of 21 patients)
Preclinical data shows activity of Civacir® against different hepatitis C virus variants
DREIEICH, GermanyI April 23, 2015 I Biotest announces today clinical and preclinical data on Civacir®, presented at The 50th International Liver Congress 2015 in Vienna, Austria.
Currently, there is no approved treatment available to prevent hepatitis C virus recurrence during and after liver transplant surgery. Although direct acting antivirals (DAAs) have the potential to reduce viral load prior to liver transplantation, hepatitis C virus recurrence is frequent. There is still a very high medical need for treatment options preventing reinfection during the critical time during and immediately after transplantation. Data presented at the congress are phase III clinical study data. The study is a randomized, open-label trial conducted in 24 clinical centers in the United States.
All patients in the study received antiviral treatment prior to transplantation, mainly new recently approved antivirals. Patients who were treated with the study drug Civacir® obtained either 200 mg/kg or 300 mg/kg body weight during and immediately after transplantation. The control group received the standard of care (no antiviral treatment after transplantation).
The clinical data shows that 1 out of 21 (5%) reinfection was observed in the high dose group. In contrast 6 out of 20 (30%) and 7 out of 22 (32%) reinfections occurred in the low dose and control group, respectively. Civacir® has been well tolerated and no serious adverse events were related to the study drug. More than two-thirds of the planned patients have been enrolled in the ongoing clinical trial.
“Civacir® represents a novel prophylactic approach to prevent hepatitis C virus recurrence in liver transplant recipients. If the presented results are also confirmed after the conclusion of the study, this would be a relevant therapy option for the treatment of transplant patients with hepatitis C.” said Dr. Bernhard Ehmer, CEO of Biotest AG.
The preclinical study presented demonstrates activity of Civacir® against different hepatitis C virus escape variants. The data shows that Civacir® may potently and dose-dependently neutralize all virus variants tested including variants resistant to neutralizing host antibodies.
“The data supports that the antibody diversity of Civacir® translates into neutralization of all viral variants analysed. Other therapies are limited by rapid viral evasion. This differentiates our polyclonal hepatitis C immune globulin approach from other therapy options.” said Dr. Jörg Schüttrumpf, Global Research of Biotest AG.
About Civacir®
Civacir® is an intravenous immune globulin preparation with a high titer of hepatitis C (HCV) antibodies. It is currently being investigated for the prevention of hepatitis C virus recurrence in patients undergoing liver transplantation. Civacir® is administered during the critical time during and after liver transplantation, when patients are receiving immunosuppressive therapy and treatment with approved antiviral therapies is not indicated.
Civacir® is developed by Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG), the only manufacturer of an investigational Hepatitis C immune globulin worldwide. Civacir® is produced from plasma of hundreds of donors with high titers of anti-HCV antibodies.
SOURCE: Biotest
Post Views: 97
Preliminary clinical results suggest that Civacir® reduces the hepatitis C virus recurrence rate after liver transplantation in an impressive way to 5% (1 out of 21 patients)
Preclinical data shows activity of Civacir® against different hepatitis C virus variants
DREIEICH, GermanyI April 23, 2015 I Biotest announces today clinical and preclinical data on Civacir®, presented at The 50th International Liver Congress 2015 in Vienna, Austria.
Currently, there is no approved treatment available to prevent hepatitis C virus recurrence during and after liver transplant surgery. Although direct acting antivirals (DAAs) have the potential to reduce viral load prior to liver transplantation, hepatitis C virus recurrence is frequent. There is still a very high medical need for treatment options preventing reinfection during the critical time during and immediately after transplantation. Data presented at the congress are phase III clinical study data. The study is a randomized, open-label trial conducted in 24 clinical centers in the United States.
All patients in the study received antiviral treatment prior to transplantation, mainly new recently approved antivirals. Patients who were treated with the study drug Civacir® obtained either 200 mg/kg or 300 mg/kg body weight during and immediately after transplantation. The control group received the standard of care (no antiviral treatment after transplantation).
The clinical data shows that 1 out of 21 (5%) reinfection was observed in the high dose group. In contrast 6 out of 20 (30%) and 7 out of 22 (32%) reinfections occurred in the low dose and control group, respectively. Civacir® has been well tolerated and no serious adverse events were related to the study drug. More than two-thirds of the planned patients have been enrolled in the ongoing clinical trial.
“Civacir® represents a novel prophylactic approach to prevent hepatitis C virus recurrence in liver transplant recipients. If the presented results are also confirmed after the conclusion of the study, this would be a relevant therapy option for the treatment of transplant patients with hepatitis C.” said Dr. Bernhard Ehmer, CEO of Biotest AG.
The preclinical study presented demonstrates activity of Civacir® against different hepatitis C virus escape variants. The data shows that Civacir® may potently and dose-dependently neutralize all virus variants tested including variants resistant to neutralizing host antibodies.
“The data supports that the antibody diversity of Civacir® translates into neutralization of all viral variants analysed. Other therapies are limited by rapid viral evasion. This differentiates our polyclonal hepatitis C immune globulin approach from other therapy options.” said Dr. Jörg Schüttrumpf, Global Research of Biotest AG.
About Civacir®
Civacir® is an intravenous immune globulin preparation with a high titer of hepatitis C (HCV) antibodies. It is currently being investigated for the prevention of hepatitis C virus recurrence in patients undergoing liver transplantation. Civacir® is administered during the critical time during and after liver transplantation, when patients are receiving immunosuppressive therapy and treatment with approved antiviral therapies is not indicated.
Civacir® is developed by Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG), the only manufacturer of an investigational Hepatitis C immune globulin worldwide. Civacir® is produced from plasma of hundreds of donors with high titers of anti-HCV antibodies.
SOURCE: Biotest
Post Views: 97
