GC开始进行乙型肝炎治疗的P2试验

StephenW

GC starts P2 trials of hepatitis B treatment

    By Lee Han-soo
    Published 2019.02.15 14:36
    Updated 2019.02.15 15:37
   
GC said Thursday that it has administered the first dose of GC1102, a new recombinant hepatitis B immunoglobulin, to a patient participating in the phase 2a clinical trial for the drug.
GC headquarters in Yongin, Gyeonggi Province.

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.

“Unlike the conventional method of isolating hepatitis B immunoglobulin from the plasmas, the treatment has a high antibody purity and excellent virus neutralization ability due to its recombinant technology,” the company said.

The trial will evaluate the efficacy and safety of GC1102 in 40 patients with chronic hepatitis B at five sites, including Severance Hospital and Seoul National University Hospital.

In particular, the study will treat patients with both GC1102 and conventional nucleic acid derivative oral antiviral agents to maximize the treatment of chronic hepatitis B, which is not yet curable.

“The ultimate goal of GC1102 development is to provide a dramatic change in the quality of life for patients by improving the treatment environment of chronic hepatitis B patients,” GC’s Medical Director Kim Jin said. “As earlier studies have identified the potential for treatment maximization, we will accelerate research to curing the illness.”

According to the company, there are about 300 million chronic hepatitis B patients worldwide.

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StephenW

GC开始进行乙型肝炎治疗的P2试验

    李汉洙
    发表于2019.02.15 14:36
    更新日期2019.02.15 15:37
   
GC周四表示，它已向参与该药物2a期临床试验的患者施用了第一剂GC1102（一种新的重组乙型肝炎免疫球蛋白）。
GC总部位于京畿道龙仁市。

GC1102，也称为Hepabig基因，采用基因重组技术制备的免疫球蛋白作为其主要治疗来源，并预防肝移植后乙型肝炎病毒感染的复发。

“与从血浆中分离乙型肝炎免疫球蛋白的传统方法不同，该治疗具有较高的抗体纯度和优异的病毒中和能力，因为其重组技术，”该公司表示。

该试验将评估GC1102在包括Severance医院和首尔国立大学医院在内的五个地点的40名慢性乙型肝炎患者中的疗效和安全性。

特别是，该研究将用GC1102和常规核酸衍生物口服抗病毒剂治疗患者，以最大限度地治疗尚未治愈的慢性乙型肝炎。

“GC1102开发的最终目标是通过改善慢性乙型肝炎患者的治疗环境，为患者的生活质量带来巨大变化，”GC医学主任Kim Jin说。 “由于早期的研究已经确定了治疗最大化的可能性，我们将加快研究以治愈疾病。”

据该公司称，全球约有3亿慢性乙型肝炎患者。