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sry,前几天这个网站打不开呀,反正我是进不来,总说在维护,但我看你们又有人上来过,我真是搞不懂。
9月24号arrowhead如约公布了结果,主要内容是下面4点:
1.HBV E-antigen positive (HBeAg-positive) patients on a background of chronic entecavir receiving a 4 mg/kg single-dose of ARC-520 showed a mean maximal 92% (1.2 log) reduction in circulating HBeAg and a best reduction of 98% (1.7 log).
2.Similar mean maximal reductions were also demonstrated in HBV core-related antigen (HBcrAg) from both HBeAg-negative and -positive patients. ARC-520 is designed to silence all gene products expressed by HBV cccDNA, so this data suggests that it may be substantially disrupting additional viral functions.
3.Arrowhead identifies a large target HBV population for ARC-520 and describes a new paradigm for the HBV lifecycle: While it is unknown what impact ARC-520's broad based effects on HBV biology will have on the sero-clearance process in any of the HBV subgroups, the effect on HBsAg in NUC-nave HBeAg-positive patients makes this group especially attractive to study and a key focus for multi-dose studies going forward.
4.Arrowhead expands its HBV portfolio by nominating an additional clinical candidate that is complementary to ARC-520; The Company expects to file an IND or equivalent for ARC-521 by mid-2016.
大家可以借助词霸勉强看一下。(就不翻译了)。
最好的结果乙肝病毒的清除率为98%(不是治愈率),应该说非常不错了。
是好事,但。。。。。。资本市场好象不买帐,股价高开后低走,原因在哪里?
当然有很多人分析,提出了很多原因,我个人脚得可能与“剂量(does)”有关,原来FDA要求的是1mg/Kg,但arrowhead公布的是4mg/Kg的结果,比原来要求的高出了三倍,尽管arrowhead公布的文件也提到了说4mg/Kg是安全的,但这话要FDA说了才算数,市场担心的是FDA有可能不同意4mg/Kg的剂量,(arrowhead前次公布的1mg/Kg病毒清除率才30%)。
在4mg/Kg剂量下病毒清除率98%,这个是我们能够见到的最好结果,找不到比这个更好的了,arrowhead公司必须证明4mg/Kg是安全的,并且FDA认可。
应该坚信一点,攻克乙肝真的快了。
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