打开APP

两种抗病毒药物将进入治疗埃博拉病毒快速临床研究阶段

  1. brincidofovir
  2. Chimerix
  3. favipiravir
  4. Fujifilm
  5. 埃博拉
  6. 抗病毒

来源:生物谷 2014-11-15 15:39

今年世界医药健康领域最为重大的事件莫过于爆发在西非的埃博拉疫情。这一疫情造成了数以千计的患者死于非命。而这一疫情,也迫使生物医药产业和世界各国政府开始正视目前治疗埃博拉病毒药物空白的这一事实。

2014年11月15日讯 /生物谷BIOON/ --今年世界医药健康领域最为重大的事件莫过于爆发在西非的埃博拉疫情。这一疫情造成了数以千计的患者死于非命。而这一疫情,也迫使生物医药产业和世界各国政府开始正视目前治疗埃博拉病毒药物空白的这一事实。

最近,研究人员宣布,两种有望治疗埃博拉病毒的药物即将进入临床研究阶段。这两种药物分别是Chimerix公司的brincidofovir和Fujifilm公司的favipiravir。根据研究人员估计,这些研究最快将于下个月启动。如果一切顺利的话,研究人员将于2015年二月份获得初步的研究结果。而这一速度也得益于相关医药管理部门对这一研究的应急审核机制。

牛津大学将领衔brincidofovir的临床研究,而法国国家健康中心则负责牵头favipiravir的临床研究。而比利时的The Antwerp Institute of Tropical Medicine同期也将进行关于埃博拉病人恢复期的治疗方案研究。

相关人士表示,这三个研究计划将有助于在短时间内找到治疗埃博拉病毒的最佳疗法并探索治疗这种疾病的联合疗法方案。

Fujifilm公司的favipiravir主要是通过阻断病毒核酸复制的方法来抑制病毒增殖的。在今年抗击埃博拉疫情的战役中,这种药物被紧急用来治疗埃博拉患者并取得了良好的效果。目前favipiravir在日本已经获批上市,而在美国也有一项用于治疗流感的研究正处于临床三期研究阶段。而Chimerix公司的brincidofovir更是在今年的埃博拉疫情中大放异彩。最近几个月,Chimerix公司正在进行brincidofovir治疗埃博拉的临床二期研究,这一研究招募了50名埃博拉患者。此前Chimerix公司CEO Michelle Berrey曾专门与FDA接洽,商议加速brincidofovir研究的可能性。(生物谷Bioon.com)

详细英文报道:

Two experimental antivirals are about to undergo snap clinical trials in Africa as doctors scramble to find an effective remedy for the lethal outbreak of Ebola. Doctors Without Borders says that it plans to launch studies of brincidofovir from Chimerix ($CMRX) as well as Fujifilm's favipiravir.

The nonprofit group plans to launch the studies next month with results available as early as February 2015. And they plan to respond quickly to any signs of progress, including adapting the trials to include combination treatments. So far the Ebola virus has killed more than 5,000 people in West Africa.

The University of Oxford will lead the Wellcome Trust-funded brincidofovir study while the French National Institute of Health and Medical Research will manage a trial using favipiravir in Guéckédou, Guinea. The Antwerp Institute of Tropical Medicine will lead a trial of convalescent whole blood and plasma therapy at the Donka Ebola centre in Conakry, Guinea.

"These three trials are part of the first phase of a research aimed at finding the best treatment to cure patients with Ebola," said Professor Denis Malvy, who will lead one of the trials in Guinea. "The three trial boards will therefore be coordinated in a very reactive way, so that any new fact can be discussed rapidly and our research plans can be adapted accordingly. Strengthening the link between our teams is all the more important as there is the possibility that, should our trials give positive results, the next phase could consist of combining interventions."

Fujifilm's antiviral, which halts viral gene replication, has already been used to successfully treat four Ebola patients, spurring new studies of the antibody cocktail and a plan to gain an emergency approval sometime next year. The treatment is already approved in Japan and is in the final stages of gaining an approval as a flu therapy in the U.S.

Durham, NC-based Chimerix, meanwhile, is pursuing its own rushed Phase II study aimed at healthcare workers infected with the Ebola virus. In recent weeks the biotech has added details on its study design listed on clinicaltrials.gov. The trial calls for 50 patients aged 2 months to 75 years old who test positive for the lethal Ebola virus. The biotech plans to start off Ebola patients with a 200-mg dose of brincidofovir (CMX001), to be followed up with four 100-mg doses over the next two weeks. The study is slated to wrap up a little more than a year from now.

Back at the beginning of October Chimerix garnered headlines around the world when the antiviral was used in a failed attempt to save a newly diagnosed--and very sick--patient in Dallas. Another case involved freelance journalist Ashoka Mukpo, who did recover. More compassionate use requests were expected, and Chimerix CEO Michelle Berrey immediately returned to the FDA to see if they could rush out a design for a formal study that could be added to their development plans for the program.

 

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->