Sangamo BioSciences血友病B基因疗法SB-FIX获FDA授予的孤儿药资格

2016-09-14 佚名生物谷

Sangamo BioSciences在基因治疗领域近年来发展十分迅速，近日美国FDA宣布，授予其锌指磷酸酶（ZFN）介导的基因编辑技术SB-FIX—血友病B疗法孤儿药资格。Sangamo计划在今年内开展1/2期临床试验，名为SB-FIX-1501。 Sangamo研发部门的首席执行官Geoff Nichol表示，对于此次FDA的决定，公司表示非常欣慰。SB-FIX作为锌指磷酸酶（ZFN）介导的

Sangamo BioSciences在基因治疗领域近年来发展十分迅速，近日美国FDA宣布，授予其锌指磷酸酶（ZFN）介导的基因编辑技术SB-FIX—血友病B疗法孤儿药资格。Sangamo计划在今年内开展1/2期临床试验，名为SB-FIX-1501。

Sangamo研发部门的首席执行官Geoff Nichol表示，对于此次FDA的决定，公司表示非常欣慰。SB-FIX作为锌指磷酸酶（ZFN）介导的基因编辑技术，能够给将凝血因子IX基因整合入患者基因组，为血友病B患者提供新型的基因治疗。目前公司将首先在成人患者中开展临床试验，然后推进到儿童，相较于成人，儿童能从治疗中取得更好的效果。值得一提的是，这是基因治疗在体内应用的另一大突破。

FDA授予的孤儿药资格认定是为了鼓励那些患者少于20万人的罕见病的药物研发，获得孤儿药资格的项目，企业将会获得一些优惠政策，例如在临床试验设计、药物研发方面获得帮助，临床试验税款减低，上市申请费用减免以及获批后长达七年的市场独占权益等等。

Sangamo的体内基因编辑方法

SB-FIX是治疗血友病B的单一疗法，能够通过基因编辑的方法，使患者稳定持续表达凝血因子IX。Sangamo公司研发的锌指磷酸酶（ZFN）介导的基因编辑技术能够利用白蛋白基因位，白蛋白是肝脏特定的“安全位点”，且能够高效表达，被锌指磷酸酶（ZFN）编辑后，能够有效地接受治疗所用的目的基因并将其表达成蛋白质。采用这一方法，患者的肝脏就能够持续地表达凝血因子IX，达到治疗水平。传统的AAV cDNA基因疗法是非整合式的，有可能随着肝脏细胞的分裂而逐渐被“洗掉”，而Sangamo的基因编辑方法能够将治疗的目的基因稳定整合进入肝脏，持续稳定地表达。

原始出处

Sangamo BioSciences Receives Orphan Drug Designation From The FDA For SB-FIX， The First Application Of Therapeutic In Vivo Genome Editing

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2017-01-17 ymljack

#Sangamo#

59 0
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2017-01-01 sunylz

#Bio#

53 0
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2017-08-05 liubm555

#SB-FIX#

54 0
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2016-09-16 jichang

#SCIE#

57 0
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2016-09-16 fengting8

#FIX#

65 0
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2016-09-15 1dd8a7c5m95(暂无匿称)

学习了，赞一个！！！

88 0
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2016-09-15 1dd8a7c5m95(暂无匿称)

学习了，赞一个！！！

106 0
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2016-09-15 1dd8a7c5m95(暂无匿称)

学习了，赞一个！！！

96 0
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2016-09-15 1dd8a7c5m95(暂无匿称)

学习了，赞一个！！！

100 0

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