Re: arc-520: 治愈乙肝的新药? (转载)# ChineseMed - 中医
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【 以下文字转载自 Biology 讨论区 】
发信人: shendoc (shendoc), 信区: Biology
标 题: Re: arc-520: 治愈乙肝的新药?
发信站: BBS 未名空间站 (Tue Aug 12 16:27:04 2014, 美东)
看起来还行吧
ARC-520 Phase 2a Study Update
Completed dosing of 1 mg/kg and 2 mg/kg dose cohorts
Initial blinded data suggest that the magnitude of HBsAg knockdown is
similar to non-human primate studies, including the chronically infected
chimpanzee reported on previously
Duration of knockdown appears to be substantially more sustained than in non
-human primates, with patients in the 2 mg/kg group still demonstrating
substantial knockdown after 8 weeks, which is the most recent time point
available
HBsAg levels appear to continue to decline in a number of patients at the 8
week time point in the 2 mg/kg group
Based on initial review, dosing less frequent than once monthly will be
explored in Phase 2b
ARC-520 continues to be well tolerated, with no dropouts or serious adverse
events reported
The overall rate of AEs has been lower in the Phase 2a than in the Phase 1
normal volunteer study and safety labs continue to show no indication of end
organ toxicity
Enrolled and dosed additional subjects at 3 mg/kg in the still open normal
volunteer study and the dose performed well, without detected differences
from safety and tolerability results at the other doses. Overall AEs do not
appear to be increasing in frequency or severity with dose
Received IRB and DSMB approvals to proceed and began enrolling an additional
dose cohort at 3 mg/kg in the Phase 2a patient study
发信人: shendoc (shendoc), 信区: Biology
标 题: Re: arc-520: 治愈乙肝的新药?
发信站: BBS 未名空间站 (Tue Aug 12 16:27:04 2014, 美东)
看起来还行吧
ARC-520 Phase 2a Study Update
Completed dosing of 1 mg/kg and 2 mg/kg dose cohorts
Initial blinded data suggest that the magnitude of HBsAg knockdown is
similar to non-human primate studies, including the chronically infected
chimpanzee reported on previously
Duration of knockdown appears to be substantially more sustained than in non
-human primates, with patients in the 2 mg/kg group still demonstrating
substantial knockdown after 8 weeks, which is the most recent time point
available
HBsAg levels appear to continue to decline in a number of patients at the 8
week time point in the 2 mg/kg group
Based on initial review, dosing less frequent than once monthly will be
explored in Phase 2b
ARC-520 continues to be well tolerated, with no dropouts or serious adverse
events reported
The overall rate of AEs has been lower in the Phase 2a than in the Phase 1
normal volunteer study and safety labs continue to show no indication of end
organ toxicity
Enrolled and dosed additional subjects at 3 mg/kg in the still open normal
volunteer study and the dose performed well, without detected differences
from safety and tolerability results at the other doses. Overall AEs do not
appear to be increasing in frequency or severity with dose
Received IRB and DSMB approvals to proceed and began enrolling an additional
dose cohort at 3 mg/kg in the Phase 2a patient study