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今年美国肝病学会的论文摘要美国肝病学会十月底到十一月初将在波士顿召开的承传。。:
http://www.aasld.org/news/100710/Pages/HEPSupplement.aspx http://www.aasld.org/news/100710/Pages/HEPSupplement.aspx
原文:原文:
482 482
REP 9AC: A POTENT HBSAG RELEASE INHIBITOR THAT回港证9AC:一个强有力的抑制剂,HBsAg的释放
CAN RAPIDLY RESTORE IMMUNOCOMPETENCE IN在迅速恢复免疫功能的CAN总线
PATIENTS WITH CHRONIC HEPATITIS B慢性肝炎患者乙
Mamun A. Mahtab, Michel Bazinet, Andrew Vaillant马蒙答Mahtab,米歇尔Bazinet的,安德鲁威能
Banga-bandhu Sheikh Mujib Medical University, Dhaka, Bangladesh;邦加,谢赫穆吉布医科大学之友,达卡,孟加拉国;
REPLICor Inc., Montreal, QC, Canada REPLICor公司,蒙特利尔,QC,加拿大
BACKGROUND:背景:
Many groups have suggested that HBsAg may许多团体都认为,乙肝表面抗原可能
play a role in suppressing the immune system and may allow发挥抑制免疫系统的作用,并可能允许
the infection to be chronically maintained in the liver.感染要长期保持在肝脏中。 REP 9AC回港证9AC
is a DNA-based amphipathic polymer which has been shown to是一种DNA为基础的两亲性聚合物,已被证明
potently inhibit the release of HBsAg from infected hepatocytes. potently抑制感染的肝细胞表面抗原的释放。
In preclinical studies in DHBV infected ducks, DHBsAg seroclearance鸭乙型肝炎病毒感染在临床前研究,DHBsAg血清廓清
was observed in all ducks after only two weeks of观察所有鸭子只有两个星期后
treatment.治疗。 Four weeks of REP 9AC therapy resulted in 55% of四个星期的Rep 9AC治疗导致55%
ducks achieving a SVR 16 weeks after cessation of treatment.鸭停止治疗后实现一个16周的SVR。
The ability of REP 9AC to treat human patients with chronic hepatitis该能力的Rep 9AC治疗慢性肝炎病人身上
B (CHB) is currently being evaluated in a proof of concept乙(乙肝)目前正在评估在概念证明
clinical trial.临床试验。
METHODS:方法:
All patients were HBeAg+, HBsAg+所有患者为HBeAg +,乙肝表面抗原+
with pre-treatment HBV DNA titers between 10^6 and 10^12与治疗前HBV DNA的10 ^ 6〜10 ^ 12滴度
copies/ml.拷贝/毫升。 Additionally, all patients were shown to have significant此外,所有患者均表现有显着
liver fibrosis as assessed by pre-treatment liver biopsy.作为评估肝纤维化治疗前肝活检。
Patients with CHB were subjected to parenteral REP 9AC therapy.慢性乙型肝炎患者进行治疗以静脉回港证9AC。
Safety and virologic response (HBV DNA, HBsAg, anti-安全和病毒学应答(乙肝病毒脱氧核糖核酸,乙肝表面抗原,抗
HBs) were assessed weekly during treatment, either at the trial哈佛商学院)在治疗期间每周进行了评估,无论是在审判
site or by confirmatory testing (HBsAg, HBeAg, anti-HBs, anti-现场或通过验证测试(乙肝表面抗原,HBeAg,抗- HBs,抗-
HBe) of frozen serum samples at a separate location using the HBe的位置在一个单独的冷冻血清样本)使用
Architect™ testing platform.建筑师™测试平台。
RESULTS:结果:
Interim data shows that 5中期数据显示,5
out of 6 patients treated to date have cleared serum HBsAg and处理,以过时的6例已经清除血清HBsAg和
anti-HBsAg antibodies have been observed in all patients.抗HBsAg抗体已被观察到所有患者。
Clearance of HBsAg and development of anti-HBs have been清除HBsAg和抗- HBs的发展已
observed as early as 7 days and no later than 15 weeks following观察早7天,不晚于15周以下
initiation of treatment at higher doses.治疗开始在更高的剂量。 At the time of当时的
abstract submission, 3 patients have achieved a 3 to 7 log提交论文摘要,3例,取得了3至7日志
reduction in their HBV DNA titers from pre-treatment levels after在他们的血清HBV DNA滴度下降,从治疗前的水平后,
7-13 weeks of treatment. 7-13周的治疗。 Additionally, two other patients have此外,另外两名病人
achieved a complete control of their infection after 23 or 24后达到23或24的感染完全控制
weeks of treatment (HBV DNA -, HBsAg -, HBeAg -, anti-HBs +,周的治疗(乙肝病毒DNA的 - ,乙肝表面抗原 - ,e抗原 - ,抗- HBs +,
anti-HBe +) and are being followed off treatment.抗- HBe +),并正在遵循了治疗。 One of these其中一个
patients is currently maintaining control over his infection 6患者目前维持对他的感染6个控制
months after stopping treatment.个月后停止治疗。
CONCLUSIONS:结论:
These results demonstrate that REP 9AC can rapidly and effectively clear这些结果表明,回港证9AC能快速有效地清除
HBsAg from the serum of infected patients.乙肝表面抗原,从被感染的患者血清。 This rapid HBsAg这种快速乙肝表面抗原
seroclearance appears to allow the restoration of an effective血清廓清似乎允许一个有效恢复
immune response, as evidenced by substantial reductions in免疫反应,这体现在大幅度减少
serum HBV DNA, seroconversion for HBsAg and HBeAg, and血清乙肝病毒的DNA,为HBsAg和HBeAg和血清转换
the achievement of a 6 month SVR in at least one patient to在至少一个病人6个月的成就SVR的到
date.日期。 These results suggest that REP 9AC may become an这些结果表明,回港证9AC可能成为
important new tool in the treatment of chronic hepatitis B.重要的新工具,在治疗慢性乙型肝炎
Disclosures:披露:
Michel Bazinet - Board Membership: REPLICor Inc.; Employment: REPLICor Inc.;米歇尔Bazinet的 - 董事会成员:REPLICor公司;就业:REPLICor公司;
Management Position: REPLICor Inc.; Stock Shareholder: REPLICor Inc.管理岗位:REPLICor公司,股份股东:REPLICor公司
Andrew Vaillant - Employment: REPLICor安德鲁威能 - 就业:REPLICor
The following people have nothing to disclose: Mamun A. Mahtab下面的人没有什么可披露:马蒙答Mahtab |
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