ACB News《澳华财经在线》报道,墨尔本沃尔特伊莉莎医学研究所(Walter and Eliza Hall Institute)乙肝新疗法临床I期试验获得成功,疗法结合了抗病毒药物entecavir和抗癌药物birinapant(美国生物科技公司TetraLogic Pharmaceuticals研发),于2014年12月进入临床I期试验,近期完成的试验证实对乙肝病毒清除率高达100%。 研究成果目前已发布于顶级综合性学术期刊PANS(美国科学院院刊),II期临床试验将在墨尔本、珀斯、阿德莱德相继展开。 乙肝病毒通常可在宿主细胞内生存长达数月、数年之久,传统疗法靶向病毒本身,容易引起抗药性。乙肝新疗法研究负责人佩莱格里尼 (Marc Pellegrini )博士表示,新疗法靶向受乙肝病毒感染的细胞信号通路,引导乙肝病毒宿主细胞直接摧毁自身,并保证其他健康肝细胞完好无损,病毒清除率得以大幅提升。并且,该疗法可扩展应用于艾滋病、肺结核等其他慢性传染病。
目前,全球乙肝病毒感染者超过20亿,约4亿人罹患慢性乙肝。乙肝病毒可诱发肝硬化、肝癌等多种并发症,每年造成约78万人死亡。
Clinical Trials
In July 2015, we announced that we intend to initiate a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects. These subjects will not be taking other antiviral medication. In the single ascending dose phase of the trial, subjects will be given a single dose of birinapant. The dose of birinapant will be escalated until at least one of the subjects shows evidence of activity, defined as an increase in liver transaminases and/or a decline in circulating viral DNA. At that point the cohort will be expanded and additional subjects will each receive four weekly administrations, at that dose, of birinapant. The starting dose of birinapant will be 2.8 mg/m2. We have retained a clinical research organization and currently expect to initiate this trial at multiple sites in India in early 2016. Timing of results will depend upon enrollment rates and upon the cohort in which activity, if any, is seen.作者: certainn 时间: 2015-11-8 11:56