GC Pharma的免疫球蛋白药物在HBV治疗中显示出潜力

StephenW

GC Pharma’s immune globulin drug shows potential in HBV treatment
2018.11.28 15:57:34 | 2018.11.28 15:58:06

   
Results of a phase I study of Hepabig-Gene, an investigational hepatitis B treatment of Green Cross Corporation (GC Pharma), were presented in a poster session at the 69th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held on Nov 9-13 in San Francisco, the Korean biopharmaceutical company announced Wednesday.

Hepabig-Gene, an immune globulin produced by recombinant DNA technology, has a higher level of antibody purity and virus-neutralizing capability than existing plasma-derived treatments.

GC Pharma is developing Hepabig-Gene as a prophylactic to the recurrence of hepatitis B in liver transplant patients, while conducting a clinical trial to evaluate whether the drug is also indicated for the treatment of chronic hepatitis B infection.

The phase I study results confirmed the new drug’s efficacy and safety profile with varying dosages in the treatment of chronic hepatitis B virus infection. No major adverse events were observed even at the maximum dosage, and researchers confirmed the dosage and dose frequency to significantly reduce the amount of hepatitis B surface antigen (HBsAg) that will result in a true cure.

"The phase I study results showed the drug’s potential to maximize the level of curing in patients with yet-incurable chronic hepatitis B and we will evaluate the drug in a phase 2a study to deepen our understanding of how to maximize the treatment through a combination therapy with antiviral drugs,” said Dr. Ahn Sang-hoon, a Severance Hospital professor who has led the study.

By Kim Hye-soon and Minu Kim

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]

StephenW

GC Pharma的免疫球蛋白药物在HBV治疗中显示出潜力
2018.11.28 15:57:34 | 2018.11.28 15:58:06

   
在美国肝病研究协会（AASLD）第69届年会的海报会议上介绍了Hepabig-Gene的第一阶段研究结果，该研究是Green Cross Corporation（GC Pharma）的乙肝治疗研究。这家韩国生物制药公司于11月9日至13日在旧金山宣布。

Hepabig-Gene是一种通过重组DNA技术生产的免疫球蛋白，与现有的血浆衍生治疗相比，具有更高水平的抗体纯度和病毒中和能力。

GC Pharma正在开发Hepabig-Gene作为肝移植患者乙型肝炎复发的预防措施，同时进行临床试验以评估该药物是否也适用于治疗慢性乙型肝炎感染。

I期研究结果证实了新药在慢性乙型肝炎病毒感染治疗中的不同剂量的疗效和安全性。即使在最大剂量下也未观察到主要不良事件，研究人员确认剂量和剂量频率可显着降低乙型肝炎表面抗原（HBsAg）的含量，从而实现真正的治愈。

“I期研究结果显示该药物可以最大限度地提高无法治愈的慢性乙型肝炎患者的治愈水平，我们将在2a期研究中评估该药物，以加深我们对如何通过联合治疗最大化治疗的理解抗病毒药物，“领导这项研究的Severance医院教授Ahn Sang-hoon博士说。

作者：Kim Hye-soon和Minu Kim

[ⓒPulse by Maeil Business News Korea＆mk.co.kr，保留所有权利]

齐欢畅

不错，免疫药

喜从天降

免疫药好啊，不仅将表抗，基本还附带防癌功效

hbv_challenger

GOOD!GOOD!