夜未眠!Seattle Genetics白血病新药SGN-CD33A爆重大安全隐患

2017-01-03 佚名 生物谷

对于Seattle Genetics公司来说,提起精神来面对刚刚到来的2017是件有点困难的事。原因是公司处于早期开发阶段的白血病药物vadastuximab talirine (SGN-CD33A)在临床早期研究中爆出重大安全隐患。有4名患者在临床研究中意外死亡。这一结果也令公司股价遭受重挫,下跌15%之多。为此,FDA已经宣布暂停了公司两项关于治疗急性粒细胞白血病的临床1/2期研究。此外,另外

对于Seattle Genetics公司来说,提起精神来面对刚刚到来的2017是件有点困难的事。原因是公司处于早期开发阶段的白血病药物vadastuximab talirine (SGN-CD33A)在临床早期研究中爆出重大安全隐患。有4名患者在临床研究中意外死亡。这一结果也令公司股价遭受重挫,下跌15%之多。

为此,FDA已经宣布暂停了公司两项关于治疗急性粒细胞白血病的临床1/2期研究。此外,另外两项临床I期研究也已经被部分暂停(不得招募新受试者,现有受试者可以继续进行研究)。

公司表示,在临床研究中已经有6名患者出现严重肝损伤,其中4名已经死亡。Seattle Genetics公司目前正在积极配合FDA,研究SGN-CD33A疗法是否引起肝毒性并积极修改现有治疗方案以保证患者安全。

抗体药物偶联技术(ADC)是Seattle Genetics公司的核心技术。此次出现问题的vadastuximab talirine也是基于这一技术开发的。事实上,ADC技术一直被认为是靶向治疗的最佳选择之一。包括艾伯维、安斯泰来、拜耳、基因泰克、葛兰素史可以及辉瑞公司都在这一领域与Seattle Genetics公司建立起了广泛合作。

此前早些时候公司开发的抗体偶联药物SGN-LIV1A在治疗三阴性乳腺癌(一种治疗难度很高的乳腺癌类型)的临床I期研究中取得不错的效果。目前公司最广为人知的产品是Adcetris (brentuximab vedotin),这种药物五年前被批准作为治疗典型性霍奇金氏淋巴瘤的二线用药。2017年Seattle Genetics是否能够否极泰来,我们还需要拭目以待。

原始出处:

Investors restless in Seattle as biotech halts leukemia tests after deaths

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    2017-02-15 huperzia
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    2017-10-29 canlab
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    2017-06-14 仁医06
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    2017-10-11 jxrzshh
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    2017-10-21 howi
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    2017-08-09 cy0324
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    2017-01-05 智智灵药