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【drug-news】FDA再次为因病人死亡而暂停的关节炎
Gene Therapy Study to Resume After Patient Death
Posted by Jacob Goldstein
The FDA has given the go-ahead for a gene therapy study that was paused after a 36-year-old arthritis patient died this summer, according to Targeted Genetics, the company that ran the study.
Investigations by company scientists, a National Institutes of Health expert panel and doctors at the University of Chicago, where the patient was transferred before she died, found no evidence that the treatment was at fault, the Washington Post reports.
The drug is injected into the joints of patients with rheumatoid arthritis. About 35 people are still eligible to get one more injection as part of the study, according to the WaPo, though it’s unclear how many will choose to do so.
Though the circumstances were quite different, the patient’s death was a reminder of the 1999 death of a teenager in a gene therapy trial at the University of Pennsylvania. Both evoke scientists’ long struggle to bring gene therapy into common use.
Targeted Genetics will probably still have to do a late-stage study before applying for FDA approval of its treatment. And, despite the findings of the NIH panel and others, the death of a patient this summer can’t be good news for the drug’s ultimate chances of approval.
Update: The Health Blog spoke with Targeted Genetics CEO Stewart Parker. “This is vindication for the drug, for the company and for the field, which has been hammered so dramatically from this tragic but coincidental event,” she said. “Gene therapy has taken a while to proven its mettle, but there are a number of studies in various diseases … and they’re all moving along very nicely. We’re just glad that in this study we’ve been able to show that this is not a gene-therapy issue.” 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 November 26, 2007, 9:41 am
Gene Therapy Study to Resume After Patient Death
Posted by Jacob Goldstein
2007年11月26日，上午09时41分
基因治疗病人死亡后研究恢复
发布者Jacob Goldstein
The FDA has given the go-ahead for a gene therapy study that was paused after a 36-year-old arthritis patient died this summer, according to Targeted Genetics, the company that ran the study.
今年夏天在一名接受基因靶向治疗36岁的关节炎病人死亡后暂停了发展中的基因治疗研究，美国食品药品管理局批准该研究的公司继续研究。
Investigations by company scientists, a National Institutes of Health expert panel and doctors at the University of Chicago, where the patient was transferred before she died, found no evidence that the treatment was at fault, the Washington Post reports.
华盛顿邮报报道，美国国家卫生研究院专家小组和病人在死亡之前的治疗单位芝加哥大学的医生等组成的科学家小组的调查没有发现任何证据表明治疗存在问题。
The drug is injected into the joints of patients with rheumatoid arthritis. About 35 people are still eligible to get one more injection as part of the study, according to the WaPo, though it’s unclear how many will choose to do so.
这种药物注射到类风湿关节炎患者的关节。约35人仍可以选择作为研究的一部分的一至多种注射液，根据该华盛顿邮报报道，尽管它目前还不清楚有多少人会选择这样做。
Though the circumstances were quite different, the patient’s death was a reminder of the 1999 death of a teenager in a gene therapy trial at the University of Pennsylvania. Both evoke scientists’ long struggle to bring gene therapy into common use.
虽然该事件的背景颇为不同，但该病人的死亡使得人们想起了 1999年在美国宾州大学进行的一个基因治疗试验中去世的一名少年。两例事件唤起了科学家使基因疗法成为普通疗法的长期奋斗。
Targeted Genetics will probably still have to do a late-stage study before applying for FDA approval of its treatment. And, despite the findings of the NIH panel and others, the death of a patient this summer can’t be good news for the drug’s ultimate chances of approval.
靶向基因疗法可能还需要做后期研究，然后才申请FDA批准其治疗。此外，尽管国家卫生研究院小组和其他科学家的调查结果，今年夏天一名患者的死亡对药物能够得到最终的批准的机会不是一个好消息。
Update: The Health Blog spoke with Targeted Genetics CEO Stewart Parker. “This is vindication for the drug, for the company and for the field, which has been hammered so dramatically from this tragic but coincidental event,” she said. “Gene therapy has taken a while to proven its mettle, but there are a number of studies in various diseases … and they’re all moving along very nicely. We’re just glad that in this study we’ve been able to show that this is not a gene-therapy issue.”
报道追踪：基因靶向治疗的首席执行官Stewart Parker在健康博客中发言： "这是对该药物，公司和该领域的辩护，它已经这个惨痛的但偶然的事件打击得够厉害了 "她说。 "基因治疗已经历了一段时间证明其实力，但也确有一些在各种疾病的研究报告，他们也进展的不错。我们只是高兴在这项研究中我们已经能够证明这不是一个基因治疗的问题" 。 编译（共591字）：
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作者:admin@医学,生命科学 2011-03-12 23:52
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