GC Pharma (formerly known as Green Cross Corporation) (KRX: 006280), a South Korean biopharmaceutical company, today announced that it will proceed with a Phase 2/3 clinical trial for GC1102 (also known as Hepabig-gene), the company’s investigational recombinant hepatitis B immune globulin for preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation.
HBV infection remains a major global issue, affecting up to 350 million people world-wide. Chronic hepatitis B patients are at considerably high risk for the development of cirrhosis and hepatocellular carcinoma. Liver transplantation is the treatment option for patients with liver failure and hepatocellular carcinoma. Approximately 1400 liver transplants are performed annually in South Korea alone. In the absence of prophylaxis or treatment, HBV reinfection and hepatitis B recurrence occurs in 80% of people who undergo orthotopic liver transplantation within 6 months.
“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,” said EC Huh, Ph. D., president of GC Pharma. “We believe GC1102 has potential to change the current treatment paradigm for hepatitis B patients.”
The clinical 2/3 trial is expected to take around 5 years to complete, with patient enrollment beginning in early 2018.