Biotest commences phase III trial of hepatitis C therapy

Biotest has commenced a phase III clinical trial of Civacir, a new ten percent hepatitis C hyperimmune globulin therapy.

The first patient has been enrolled in the North American study, which assesses the benefits of the drug as a therapy for patients undergoing liver transplantation as a consequence of hepatitis C infection.

End-stage liver disease due to hepatitis C virus is a common indicator for liver transplantation, but because newly transplanted livers can be rapidly infected by any viruses that are still circulating in the body, reinfection occurs in around 80 percent of cases within four weeks of transplantation.

Currently, there are no approved treatments for the prevention of recurrent infections of this kind, leading regulators in the US and EU to grant Civacir an orphan drug designation.

This will ensure that the drug will benefit from market exclusivity for seven and ten years respectively after approval in the two territories.

Biotest employs around 1,700 people in major European countries and has been operating in the UK for more than 30 years.