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【medical-news】禽流感疫苗贴剂获批进行更大范围试验

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Small company gets U.S. go-ahead on bird flu patch

WASHINGTON (Reuters) - A small biotechnology company trying to develop needle-free vaccines won a boost to its efforts on Tuesday with U.S. government approval to test a bird flu skin patch on more people.

Iomai's patch is not a vaccine, but rather delivers what is called an adjuvant -- an immune boosting agent that will be delivered along with a vaccine to try to make it work better.

The vote of confidence from the Health and Human Services Department adds impetus to all of the company's projects.

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," Stanley Erck, president and chief executive officer of Iomai, said in a statement.

HHS, which gave Iomai $128 million to work on the patch last year, said the company could do a phase 2 safety trial -- typically involving a few dozen people to see if a product is safe and whether there is any indication it works.

If a phase 2 trial succeeds, companies can move to phase 3 studies, which are carefully designed to prove a product has the intended effect and are needed for final approval by the U.S. Food and Drug Administration.

Last month, the company reported the skin patch helped boost a bird flu vaccine so well that people appear to be protected by a single dose.

This could help stretch vaccine supply during a pandemic.

Often, adjuvants are mixed right in with a vaccine but Dr. Anthony Fauci of the National Institute for Allergy and Infectious Diseases said there is reason to believe a patch may work better.

"Right beneath the skin are a group of cells called Langerhans cells," Fauci said in a telephone interview.

"When you put the patch on the skin, they take up the adjuvant and go directly to the lymph nodes. The thought is that ... you will get a more robust response."

Current approved vaccines against the H5N1 avian influenza virus require two doses to be fully effective.

The patch, applied after gently scraping the skin with a light, sandpaper-like device, is being used to boost an H5N1 vaccine made by the Belgian drug company Solvay.

The H5N1 avian flu virus is sweeping through flocks of poultry in Asia and sometimes Africa and Europe. It has infected 380 people in 14 countries and killed 240 of them since 2003.

The fear is that the virus might change just enough to pass easily from one person to another, sparking a deadly pandemic.

At least 16 companies are testing H5N1 vaccines. But global flu vaccine production capabilities are limited and if larger doses are needed, fewer people could be vaccinated in a pandemic.

Iomai is also working to use its needle-free technology to make vaccines against anthrax, seasonal influenza and traveler's diarrhea.

Last week, it won a grant of up to $943,856 from the U.S. Army Medical Research and Materiel Command to do preclinical work on a patch-based version of the anthrax vaccine.

The current anthrax vaccine licensed in the United States is given in six different injections over 18 months and must be refrigerated.

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2008-04-16 11:29 浏览 : 942 回复 : 4

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2008-04-16 12:38

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Small company gets U.S. go-ahead on bird flu patch
小公司美国获准禽流感贴剂扩大试验

WASHINGTON (Reuters) - A small biotechnology company trying to develop needle-free vaccines won a boost to its efforts on Tuesday with U.S. government approval to test a bird flu skin patch on more people.
华盛顿（路透社电）-一家小型生物技术公司研发的无针疫苗前景看好，周二美国政府批准扩大该禽流感皮肤贴剂的试验人数。

Iomai's patch is not a vaccine, but rather delivers what is called an adjuvant -- an immune boosting agent that will be delivered along with a vaccine to try to make it work better.
Iomai的贴剂不是疫苗，而是提供一种所谓佐剂-一种免疫促进剂，随疫苗使用，使其效果更好。

The vote of confidence from the Health and Human Services Department adds impetus to all of the company's projects.
卫生和福利部的肯定为公司的所有项目增添动力。

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," Stanley Erck, president and chief executive officer of Iomai, said in a statement. “Iomai的免疫诱导贴剂可能改变我们应对流感大流行的方式，借力此技术我们也能继续快速发展，”Iomai 的总裁兼首席执行官Stanley Erck在一份声明中说。

HHS, which gave Iomai $128 million to work on the patch last year, said the company could do a phase 2 safety trial -- typically involving a few dozen people to see if a product is safe and whether there is any indication it works.
卫生和福利部去年拨给Iomai1亿2800万美元用于该贴剂研究，认为该公司可以做二期临床安全试验-通常在几十人试验，看看产品是否安全，以及是否有任何迹象显示它的作用。

If a phase 2 trial succeeds, companies can move to phase 3 studies, which are carefully designed to prove a product has the intended effect and are needed for final approval by the U.S. Food and Drug Administration.
如果二期临床试验成功，公司可以继续三期临床研究，试验需要精心设计，来证明其产品具有预期的效果，籍此最终获得美国FDA的批准。

Last month, the company reported the skin patch helped boost a bird flu vaccine so well that people appear to be protected by a single dose.
上个月，该公司报告皮肤贴剂有效的提高了禽流感疫苗的作用，单次免疫就使人获得保护。

This could help stretch vaccine supply during a pandemic.
这可能有助于舒缓大流行时的疫苗供应问题。

Often, adjuvants are mixed right in with a vaccine but Dr. Anthony Fauci of the National Institute for Allergy and Infectious Diseases said there is reason to believe a patch may work better.
很多时候，佐剂是和疫苗直接混合使用的，但国立过敏和传染病研究所的医生Anthony Fauci说，我们有理由相信贴剂的效果更好。

"Right beneath the skin are a group of cells called Langerhans cells," Fauci said in a telephone interview.
“皮肤底下是一组称为Langerhans细胞的细胞，”Fauci在接受电话采访时说。

"When you put the patch on the skin, they take up the adjuvant and go directly to the lymph nodes. The thought is that ... you will get a more robust response."
“当你把贴剂贴在肌肤上，皮肤吸收了佐剂，并直接进入淋巴结。观点就是...你会得到一个作用更强的免疫反应" 。

Current approved vaccines against the H5N1 avian influenza virus require two doses to be fully effective.
目前已批准的针对H5N1禽流感病毒的疫苗，需要两剂才能充分发挥效力。

The patch, applied after gently scraping the skin with a light, sandpaper-like device, is being used to boost an H5N1 vaccine made by the Belgian drug company Solvay.
贴剂贴在皮肤上后，用一种轻便的砂纸般的装置，轻轻地刮擦皮肤，可以加强单次H5N1疫苗的效果，该疫苗由比利时Solvay生产。

The H5N1 avian flu virus is sweeping through flocks of poultry in Asia and sometimes Africa and Europe. It has infected 380 people in 14 countries and killed 240 of them since 2003.
H5N1型禽流感病毒席卷了亚洲，非洲和欧洲成群的家禽。从2003年开始，在14个国家它已经感染了380人，死亡 240人。

The fear is that the virus might change just enough to pass easily from one person to another, sparking a deadly pandemic.
令人担心的是，这种病毒可能已经变化得能在人群间轻易传播，从而引发一场致命的瘟疫。

At least 16 companies are testing H5N1 vaccines. But global flu vaccine production capabilities are limited and if larger doses are needed, fewer people could be vaccinated in a pandemic.
至少有16家企业正在测试H5N1病毒的疫苗。但是全球流感疫苗生产能力有限，如果需要较高的剂量，大流行时能接种疫苗的人就更少了。

Iomai is also working to use its needle-free technology to make vaccines against anthrax, seasonal influenza and traveler's diarrhea.
Iomai正致力于用自己的无针技术制造炭疽热、季节性流感和旅行腹泻的疫苗。

Last week, it won a grant of up to $943,856 from the U.S. Army Medical Research and Materiel Command to do preclinical work on a patch-based version of the anthrax vaccine.
上周，它获得美陆军医学研究与物资司令部高达943856美元的资助，用于炭疽疫苗贴剂的临床前工作。

The current anthrax vaccine licensed in the United States is given in six different injections over 18 months and must be refrigerated.
目前美国批准的炭疽疫苗需要注射6次，时间超过18个月，而且必须冷藏。

小公司美国获准禽流感贴剂扩大试验
华盛顿（路透社电）-一家小型生物技术公司研发的无针疫苗前景看好，周二美国政府批准扩大该禽流感皮肤贴剂的试验人数。

Iomai的贴剂不是疫苗，而是提供一种所谓佐剂-一种免疫促进剂，随疫苗使用，使其效果更好。

卫生和福利部的肯定为公司的所有项目增添动力。

“Iomai的免疫诱导贴剂可能改变我们应对流感大流行的方式，借力此技术我们也能继续快速发展，”Iomai 的总裁兼首席执行官Stanley Erck在一份声明中说。

卫生和福利部去年拨给Iomai1亿2800万美元用于该贴剂研究，认为该公司可以做二期临床安全试验-通常在几十人试验，看看产品是否安全，以及是否有任何迹象显示它的作用。

如果二期临床试验成功，公司可以继续三期临床研究，试验需要精心设计，来证明其产品具有预期的效果，籍此最终获得美国FDA的批准。

上个月，该公司报告皮肤贴剂有效的提高了禽流感疫苗的作用，单次免疫就使人获得保护。

这可能有助于舒缓大流行时的疫苗供应问题。

很多时候，佐剂是和疫苗直接混合使用的，但国立过敏和传染病研究所的医生Anthony Fauci说，我们有理由相信贴剂的效果更好。

“皮肤底下是一组称为Langerhans细胞的细胞，”Fauci在接受电话采访时说。

“当你把贴剂贴在肌肤上，皮肤吸收了佐剂，并直接进入淋巴结。观点就是...你会得到一个作用更强的免疫反应" 。

目前已批准的针对H5N1禽流感病毒的疫苗，需要两剂才能充分发挥效力。

贴剂贴在皮肤上后，用一种轻便的砂纸般的装置，轻轻地刮擦皮肤，可以加强单次H5N1疫苗的效果，该疫苗由比利时Solvay生产。

H5N1型禽流感病毒席卷了亚洲，非洲和欧洲成群的家禽。从2003年开始，在14个国家它已经感染了380人，死亡 240人。

令人担心的是，这种病毒可能已经变化得能在人群间轻易传播，从而引发一场致命的瘟疫。

至少有16家企业正在测试H5N1病毒的疫苗。但是全球流感疫苗生产能力有限，如果需要较高的剂量，大流行时能接种疫苗的人就更少了。

Iomai正致力于用自己的无针技术制造炭疽热、季节性流感和旅行腹泻的疫苗。

上周，它获得美陆军医学研究与物资司令部高达943856美元的资助，用于炭疽疫苗贴剂的临床前工作。

目前美国批准的炭疽疫苗需要注射6次，时间超过18个月，而且必须冷藏。

2008-04-17 11:34

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• 坚持这 4 件小事，免费得用药助手专业版会员

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试编译：
禽流感病毒肆虐，人类大流感山雨欲来。未雨绸缪，多家制药公司致力研发禽流感病毒疫苗。小公司Iomai独辟蹊径，开发禽流感疫苗的免疫佐剂-贴剂，1期临床试验效果良好，目前已被批准扩大临床试验。该增强免疫的贴剂不仅简化了给药方式，还有效增强了H5N1病毒疫苗的免疫效果，二者联合免疫，1次即可获得有效的免疫力，而单用疫苗，则需用2次。因此在全球流感疫苗生产供应有限的情况下，有该贴剂协助，可以有效的降低流感疫苗的免疫剂量，有可能在将来流感爆发时使更多的人得到有效免疫，从而减缓疫苗供应紧张的局面。禽流感疫苗免疫贴剂项目获得美国卫生和福利部上亿美元的资金支持，该项目的进展顺利也有效推动了Iomai公司其他项目的发展。他们计划采用自己的无针免疫贴剂技术研发针对炭疽热、季节性流感和旅行腹泻的疫苗。目前美陆军医学研究与物资司令部资助该公司开发炭疽疫苗的贴剂。

人无我有，人有我优，才是商业的成功之道
Iomai的成功值得小公司学习啊！

2008-04-17 12:16

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