Recombinant Product in Clinical Development for Most Common Liver Transplantation Risk
YONGIN, South Korea I August 27, 2014 I Green Cross, a South Korean biopharmaceutical company, today announced initiation of a Phase II clinical trial to evaluate the safety and efficacy of ‘Hepabig-gene’, Green Cross’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 700 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. ‘Hepabig-gene’ does not contain plasma-based additives,” said Hyi-Jeong Ji, Ph. D., senior vice president of Green Cross Corporation. “The initiation of ‘Hepabig-gene’ Phase II clinical trial represents an important step forward as the product. It may lead to an alternative treatment choice for physicians and patients who undergo orthotopic liver transplantation.”
Green Cross has a plan to assess the safety and effectiveness of ‘Hepabig-gene’ through global clinical trials. Both the European Medicine Agency and the U.S Food and Drug Administration granted orphan drug designation for ‘Hepabig-gene’ last year.
About Green Cross
Green Cross provides total healthcare solutions that address the evolving needs of human health. Headquartered in Yongin, South Korea, Green Cross specialises in the development and manufacture of plasma-derivatives, vaccines and recombinant proteins.
SOURCE: Green Cross
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Recombinant Product in Clinical Development for Most Common Liver Transplantation Risk
YONGIN, South Korea I August 27, 2014 I Green Cross, a South Korean biopharmaceutical company, today announced initiation of a Phase II clinical trial to evaluate the safety and efficacy of ‘Hepabig-gene’, Green Cross’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 700 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. ‘Hepabig-gene’ does not contain plasma-based additives,” said Hyi-Jeong Ji, Ph. D., senior vice president of Green Cross Corporation. “The initiation of ‘Hepabig-gene’ Phase II clinical trial represents an important step forward as the product. It may lead to an alternative treatment choice for physicians and patients who undergo orthotopic liver transplantation.”
Green Cross has a plan to assess the safety and effectiveness of ‘Hepabig-gene’ through global clinical trials. Both the European Medicine Agency and the U.S Food and Drug Administration granted orphan drug designation for ‘Hepabig-gene’ last year.
About Green Cross
Green Cross provides total healthcare solutions that address the evolving needs of human health. Headquartered in Yongin, South Korea, Green Cross specialises in the development and manufacture of plasma-derivatives, vaccines and recombinant proteins.
SOURCE: Green Cross
Post Views: 101
