By Lee Han-soo
Published 2019.02.26 16:07
Updated 2019.02.26 16:07
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GC said Monday that it has presented the phase 1 clinical trial results for GC1102, a new recombinant hepatitis B immunoglobulin, at the annual Asian Pacific Association for The Study of the Liver Conference.
Professor Lee Hae-won presents the phase 1 clinical trial for Hepabig-gene, at the 2019 Asian Pacific Association for the Study of the Liver Conference held in the Philippines.
GC1102, also known as Hepabig-gene, employs immunoglobulins made from genetic recombination technology as its primary treatment source and prevents the recurrence of hepatitis B virus infection following liver transplantation.
In the presentation, the company unveiled a result confirming the efficacy and safety of the drug against chronic hepatitis B patients.
In particular, there were no severe side effects when the company increased the dose of Hepabig-gene to a maximum, and the dose and frequency of administration. The company also confirmed that the treatment could significantly reduce hepatitis B surface antigen.
“Participants in the meeting were interested in the possibility of improving the treatment level of chronic hepatitis B with Hepabig-gene,” said Professor Lee Hae-won of the department of gastroenterology at Severance Hospital who presented the study. “We will specify a method of maximizing treatment through a combination treatment of Hepabig-gene and antiviral drug during the phase 2 clinical trial.”
The company reportedly had administered the first dose of GC1102 to a patient participating in the phase 2a clinical trial on Feb. 15. 作者: StephenW 时间: 2019-2-28 17:31
乙型病毒性肝炎(viral hepatitis type B，简称乙肝)系由乙肝病毒(HBV)引起，以乏力、食欲减退、恶心、呕吐、厌油、肝大及肝功能异常为主要临床表现。部分病例有发热和黄疸；少数病例病程迁延转为慢性，或发展为肝硬化甚至肝癌；重者病情进展迅猛可发展为重型肝炎；另一些感染者则成为无症状的病毒携带者。乙肝病毒感染仍是一个非常重要的全球性问题，在全球范围内影响多达3.5亿人。慢性乙肝患者具有发生肝硬化和肝细胞癌的高危风险。肝脏移植乃是针对肝脏衰竭和肝细胞癌患者的治疗方案。仅在韩国，每年就开展了大约1400例肝脏移植手术。由于缺少预防/治疗，乙肝病毒感染和乙肝在原位肝脏移植患者6个月内的复发率高达80%。