GC Pharma, a South Korean biopharmaceutical company affirmed that it will conduct Phase 2/3 clinical trial for GC1102, the company’s investigational recombinant hepatitis B immune globulin in order to combat recurrence of hepatitis B virus infection post Liver transplantation. The clinical 2/3 trial is expected to take around 5 years to complete, with patient enrollment beginning in early 2018.
According to estimates, HBV infection afflicts up to 350 million patients globally. Chronic hepatitis B patients are at considerably high risk for the development of cirrhosis and hepatocellular carcinoma. Patients grappling with liver failure and hepatocellular carcinoma have to undergo liver transplantation as the only feasible alternative. Approximately 1400 liver transplants are performed annually in South Korea alone. HBV reinfection and hepatitis B recurrence likely to inflict on 80% of the people 6 months after having undergone orthotopic liver transplantation.
EC Huh, Ph. D., president of GC Pharma said “Currently available treatments that are effective for hepatitis B recurrence following liver transplantation are hepatitis B immune globulin derived from human plasma. GC1102 – does not contain plasma-based additives – may offer innovative and more effective alternatives, as there are no other recombinant treatments available.”