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美国新禽流感高剂量药物安全研究
Fri 29 Sep 2006 20:28:43 BST
(Writes through with BioCryst CEO, previous NEW YORK)
WASHINGTON, Sept 29 (Reuters) - A new drug being developed to fight both bird flu and seasonal flu can be given safely to people in very high doses, BioCryst Pharmaceuticals Inc. <BCRX.O> said on Friday.
The drug, called peramivir, is still in experimental trials but is considered the next-line drug to fight influenza of all sorts, after Tamiflu and Relenza.
Experts want to have several antivirals to choose from in fighting flu because the virus mutates quickly, and because no drug has been completely effective.
"We demonstrated that you can go to very high levels of peramivir in humans," Dr. Charles Bugg, Chairman and Chief Executive Officer of BioCryst, said in a telephone interview.
"We did escalating doses -- starting at a low dose and showing it's safe and going until we have a dose way, way above what we think it takes to inhibit the virus. We can go to very high levels," Bugg added.
They gave more than 60 healthy volunteers intravenous peramivir each day for up to 10 days in doses ranging from about 30 mg to 600 mg.
All doses were well tolerated with no serious adverse effects, researchers independent of the company told a meeting in San Francisco of the American Society for Microbiology.
The U.S. Food and Drug Administration gave peramivir "fast-track status" in January to allow speedy review for approval. The company has said peramivir has shown broad spectrum activity against various strains of flu, including the H5N1 virus that causes bird flu, in animal trials.
The oldest influenza drugs, amantadine and rimantadine, are no longer recommended for use against seasonal flu because the viruses largely resist them.
RESISTANCE TO TAMIFLU
Roche <ROG.VX> and Gilead Sciences Inc.'s <GILD.O> Tamiflu, also known as oseltamivir, also works against both seasonal flu and H5N1 avian influenza. Tamiflu is now routinely given to bird flu victims, but some strains of bird flu have already begun to evolve resistance to Tamiflu.
H5N1 mainly affects birds but experts fear it could mutate into a strain capable of killing millions of people in a global pandemic. It has killed 148 people out of 251 infected in 10 countries since 2003.
Relenza, made by GlaxoSmithkline <GSK.L> <GSK.N> under license from Australia's Biota <BIOT.AX> is an inhaled drug that also appears to treat both types of flu.
"There is really nothing now behind Tamiflu and Relenza as potential agents that could be made available," Bugg said.
He said mutation of the viruses is the reason for testing very high doses of drugs. "You hit them with a drug and they eventually will figure out how to get around the drug. The way you get around this is to go in with huge amounts," Bugg said.
Bugg said peramivir is easier to make than Tamiflu, which requires rare ingredients.
"We can manufacture large amounts of peramivir," he said.
He said one Swiss manufacturer can make one metric ton of peramivir a month, and the company had identified a U.S. facility that can be up and running in seven months.
He estimates that one ton of peramivir would treat 8 million flu patients.
"It is not enough to treat everybody but we have got enough to treat millions and millions per month," Bugg said.
Peramivir can be given either as an infusion or as an injection.
(With additional reporting by Edward Tobin in New York); 认领试试
多谢多谢！ 美国新禽流感高剂量药物安全研究
2006年9月29日星期五 BST时间: 20:28:43
（前纽约BioCryst药厂首席执行官写道）
华盛顿九月二十九日—— 周五 BioCryst药业称，其研制的一种抵御禽流感和季节性感冒的新药，能以高剂量安全地应用。
这种叫作peramivir的新药，尽管尚处于实验阶段，但被认为是在Tamiflu及瑞乐砂之后，用于抵御多种流感的二线用药。
由于流感病毒变异很快，专家们希望在对付流感时 能有多种抗病毒药物以供选择，因为没有一种药物是完全有效的。
在电话采访中，BioCryst的主席兼首席执行官Charles Bugg医生说道：“我们认为，peramivir在人类可用到相当高的剂量。”
“我们从小剂量开始逐步增加，显示这是安全地，直到我们有了这种药的用量标准，它很高，高于抑制病毒的剂量。” Bugg补充道
他们每天对60名以上的健康自愿者静注peramivir，以30到60毫克的剂量持续十天。
所有剂量的耐受性都很好，没有严重的副作用，该公司外的研究人员在旧金山美国微生物协会大会上如是说。
美国食品药品管理局一月 称peramivir是“快速追踪者”，对如此快出现的赞同意见表示支持。该公司称peramivir在动物实验中显示出，对多种流感其抗菌普很广，包括导致禽流感的H5N1病毒。
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作者:admin@医学,生命科学 2010-12-18 05:11
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