Chimerix着手开展利用brincidofovir治疗埃博拉病毒研究

今年三月份，生物技术公司Chimerix公司因为一名极度虚弱的儿童而置身于全美媒体的风暴中心。然而迫于FDA关于新药的相关规定，Chimerix公司始终拒绝使用公司未进入临床研究阶段的药物治疗该儿童。此事一经国外媒体披露，立刻引发了社会大众关于医药伦理问题的讨论。随后，Chimerix公司被迫宣布将进行一项先行试验研究公司开发的特效药物brincidofovir治疗新病毒感染的研究。

如今，Chimerix公司计划进一步拓展brincidofovir的应用，研究其对埃博拉病毒的疗效。公司CEO Michelle Berrey表示，公司希望对这一领域展开正式的系统的临床研究，而不是一再的针对个体紧急案例提供先行研究。公司将首先与FDA合作进行针对埃博拉病的初步研究，随后将同欧洲的医药管理部门合作进行进一步的研究。

而本周早些时候，美国达拉斯的一名埃博拉患者就已经开始接受brincidofovir的治疗，这一消息也刺激Chimerix公司股价上扬。而今年以来在西非地区爆发的埃博拉疫情在客观上为Chimerix公司开展brincidofovir治疗埃博拉病毒的临床研究提供了条件。同时Berrey也指出，埃博拉病毒将成为公司研发的一个重要方面，但是就现阶段而言，公司研究业务的重中之重仍然是腺病毒、巨细胞病毒和天花病毒等病毒的治疗。同时，公司并不认为brincidofovir能成为彻底解决埃博拉病毒的一种治疗方案。

Brincidofovir是一种脂质化的西多福韦。西多福韦是由吉利德公司开发的一种特效抗病毒药物。Brincidofovir能够放大西多福韦的抗病毒疗效，同时避免西多福韦对肾脏的毒害作用。相较于西多福韦，这种药物对DNA病毒具有更好的疗效，但是对人体一些增殖迅速的细胞如骨髓中的造血干细胞等会造成危害。目前brincidofovir尚处于临床研发阶段，有一系列问题亟待解决。

详细英文报道：

Back in March, after being thrust into the center stage of a national media storm stirred by the parents of a desperately sick young boy, Chimerix hustled to put together a small Phase III pilot program to test its closely watched antiviral brincidofovir for adenovirus infections. Today, CEO Michelle Berrey says the company is now scrambling to put together another overnight study plan for Ebola rather than risk getting hit with a fresh round of compassionate-use demands.

"The same as adenovirus, we strongly prefer to have clinical trials" rather than provide the antiviral for individual emergency cases, says Berrey. Over the next 24 to 48 hours, she adds, Chimerix plans to hammer out a study plan for Ebola with the FDA and then follow up with officials in Europe.

Earlier this week Chimerix shares ($CMRX) jumped on the news that an Ebola patient in Dallas had been treated with brincidofovir, with physicians saying that more compassionate use cases could follow. But that's exactly the kind of case-by-case emergency use that the company has been trying to avoid for the past two years, as word of the powerful, but experimental, antiviral spread.

By lining up centers for the study in Europe and the U.S. which can stock brincidofovir for use with patients who find themselves infected after returning from the hot zone in West Africa, the company can meet the demand much more efficiently, says Berrey. And the company also expects to clear the study, which can better examine the right dosage as well as the impact on side effects for Ebola patients, with the EMA and individual European countries.

"Ebola is something we don't want to walk away from given the outbreak," says the CEO. But she also doesn't want the work to distract from the company's core focus on CMV, adenovirus and smallpox. "We're not going to be the solution to the Ebola epidemic," but there's also good reason to explore how brincidofovir can be used to prevent the spread of Ebola. Currently there are no plans for the company to mount a large study in Africa.

Brincidofovir is a lipid-conjugated version of cidofovir--one of Gilead's ($GILD) antivirals--that's specifically designed to amp up the antiviral impact with a pill while sparing kidneys from a toxic threat. Its ability to get into cells more effectively than cidofovir has vastly improved its punch against all 5 DNA viral infections but has also raised questions about whether it could prove a threat to all rapidly growing cells, including cells in the bone marrow.

Over the past three months, the biotech's stock has gyrated up 45%.