Ziopharm实验性基因治疗药物致一名患者死亡，股价下泻16%

2016-07-18 MedSci MedSci原创

美国生物科技公司Ziopharm Oncology Inc宣布，一名脑癌患者在开始接受公司主要实验性癌症药物Ad-RTS-hIL-12治疗大约两周后，因颅内出血而死亡。消息发布后，周五该股票大跌16%。FDA已授予用于治疗恶性胶质瘤的药物Ad-RTS-hIL-12 + veledimex孤儿药资格。Ad-RTS-hIL-12是一种新型的基因治疗候选药物，用于控制IL-12的基因表达，其为激活抗癌T

美国生物科技公司Ziopharm Oncology Inc宣布，一名脑癌患者在开始接受公司主要实验性癌症药物Ad-RTS-hIL-12治疗大约两周后，因颅内出血而死亡。消息发布后，周五该股票大跌16%。

FDA已授予用于治疗恶性胶质瘤的药物Ad-RTS-hIL-12 + veledimex孤儿药资格。Ad-RTS-hIL-12是一种新型的基因治疗候选药物，用于控制IL-12的基因表达，其为激活抗癌T细胞免疫应答的关键蛋白。

临床试验的11个复发性高级别胶质瘤患者通过脑部肿瘤直接注射基因治疗药物Ad-RTS-hIL-12的同时口服Veledimex治疗至今，在此前研究中，其中的7个病人在最初的试验剂量组（口服veledimex剂量20 mg），4个病人在目前进行的剂量组（口服veledimex剂量40 mg）。口服Veledimex的目的是刺激肿瘤部位IL-12的合成，介导机体免疫反应。在此前研究显示，传统疗法对本次临床试验招募的患者已经无效，通过上述的基因治疗后，其中位生存期明显提高。即使在最低给药剂量情况下，也能检测到血管中IL-12，表明口服veledimex发挥了预期效果。此外，出现药物副作用的患者中断口服veledimex后，副作用症状很快消失。

但此次患者死亡的具体原因还有待进一步调查。

周五早晨，Ziopharm发布公告称，仍在收集和分析有关这起死亡事件的数据。该公司称：“本次一期试验针对晚期复发性胶质母细胞瘤患者，这些患者本身在医学上非常脆弱。”

Ad-RTS-hIL-12由总部位于美国马萨诸塞州的Ziopharm与Intrexon Corp联合开发，该药物直接注入患者肿瘤部位，以激起消灭癌症的免疫应答。Ziopharm还透露，试验中另有两名患者死亡，但死因与该药物无关。

Ziopharm称，本次试验的患者招募工作将继续进行，下一阶段的行动将由公司内部安全评审委员会讨论决定。

该实验性基因疗法正在评估用于治疗胶质母细胞瘤，这是一种常见而又致命的耐药性脑癌。另外，该药物还在进行治疗乳癌的中期试验。

胶质母细胞瘤患者通常会在被诊断出来后的15个月内死亡。目前的主流疗法是手术，其次是放疗和化疗。据美国神经外科医师学会统计，近几十年来推出的最有效疗法也仅仅能使患者存活时间中位数延长3个月左右。

近期实验性抗癌药物频频遭遇挑战。上周，Juno Therapeutics Inc开发的基因工程癌症药物因为导致三名患者死亡被迫暂停临床试验。本周美国食品药品监督管理局批准该公司恢复试验（FDA许可Juno继续进行CAR-T细胞治疗临床试验，化疗药物更换为环磷酰胺（ROCKET试验））。

ZIOPHARM肿瘤制药公司是一家位于马萨诸塞州波士顿市的生物科技公司，致力于通过新型基因表达、控制和细胞技术，为癌症的治疗传递安全、有效和扩展性的细胞治疗方法。同Intrexon公司和MD安德森癌症中心合作的合成免疫肿瘤项目包括嵌合抗原受体T细胞（CAR-T）和其他用非病毒转基因方法来进行传递。Intrexon公司的RheoSwitch 治疗系统®技术，一种用“开关”来精确调节基因表达的开启与关闭的技术，目的是提高治疗指标。公司正加快在多个领域的项目中应用上述技术的开发。公司的渠道包括若干专注于血液病和恶性实体肿瘤临床和临床前测试方面的细胞治疗方法（1亿美金，Intrexon与Ziopharm为CAR-T研究再添一把火！）。

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2016-12-31 jj000001

#Pharm#

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2017-04-02 sunylz

#患者死亡#

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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151110/IMG5641A6F12C0732294.jpg, createdBy=2f901662448, createdName=乐奕11, createdTime=Tue Jul 19 19:04:00 CST 2016, time=2016-07-19, status=1, ipAttribution=)]
2017-06-25 124987c6m46暂无昵称

#IOP#

84 0
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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151110/IMG5641A6F12C0732294.jpg, createdBy=2f901662448, createdName=乐奕11, createdTime=Tue Jul 19 19:04:00 CST 2016, time=2016-07-19, status=1, ipAttribution=)]
2017-05-03 周虎

#治疗药物#

71 0
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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151110/IMG5641A6F12C0732294.jpg, createdBy=2f901662448, createdName=乐奕11, createdTime=Tue Jul 19 19:04:00 CST 2016, time=2016-07-19, status=1, ipAttribution=)]
2016-12-31 lujian

#实验性#

75 0
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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20151110/IMG5641A6F12C0732294.jpg, createdBy=2f901662448, createdName=乐奕11, createdTime=Tue Jul 19 19:04:00 CST 2016, time=2016-07-19, status=1, ipAttribution=)]
2016-09-20 ylzr123

好文章，赞一个！深入学习，探究。

103 0
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2016-08-28 乐奕11

厉害

110 0
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2016-07-24 zzhyy

药物的前期研究最重要

137 0
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2016-07-19 doctorJiangchao

继续学习^_^

126 0
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2016-07-19 乐奕11

实验的结果重要，但过程更重要

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