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【medical-news】Dynavax称其乙型肝炎疫苗临床试验优
Dynavax称其乙型肝炎疫苗临床试验优于对照疫苗
Last Updated: 2006-11-29 10:00:06 -0400 (Reuters Health)
LOS ANGELES (Reuters) - Dynavax Technologies Corp. Tuesday said its experimental vaccine for hepatitis B protected 100 percent of adults in a late-stage trial compared with a rival vaccine's rate of about 73 percent.
洛杉矶（路透社）—Dynavax技术公司周四宣布，其公司研制的乙型肝炎疫苗在临床后期试验表明，可100%保护老龄人群，而对照疫苗仅为73%。
The company's shares rose about 32 percent in after-hours trading.
该公司股票在其后交易中攀升32%。
Dynavax said the trial found that three doses of its vaccine, called Heplisav, provided protection against the virus in 100 percent of subjects, compared with 73.1 percent of subjects receiving another vaccine called Engerix-B, made by GlaxoSmithKline Plc.
Dynavax 宣称，Heplisav的临床试验表明三次给药后，100%受试者具有对病毒的保护作用，而葛兰素史克公司的Engerix-B仅为73.1%。
After two doses, Heplisav protected 98.5 percent of those treated, compared with 25 percent for Engerix-B, the company said.
该公司称，二次给药，Heplisav的保护率为98.5%，而Engerix-B为25%。
Berkeley, California-based Dynavax said the results of the trial, which involved 400 adults aged 40 to 70 in Singapore, South Korea and the Philippines, were statistically significant.
位于加州伯可利的Dynavax公司宣称，来自新加坡、韩国和菲律宾的400名年龄在40到70岁的成年参与了该项试验，其试验结果具有显著统计学意义。
"The most striking outcome from the trial is the vaccine's ability to generate 98.5 percent protection after two doses in older difficult-to-immunize adults. This has the potential to drive an important change in the way people are immunized against hepatitis B," Chief Executive Dr. Dino Dina said in a statement.
“该项试验最令人惊喜的结果是，该疫苗二次给药后，能够使98.5%的难以获得免疫力的老年人对乙型肝炎产生免疫保护作用。”执行总裁Dino Dina 博士在报告中说道。
Dynavax said it plans to pursue approval of a two-dose regimen, and expects to initiate international phase 3 trials in Europe, Canada and the United States before the end of this year to compare the two-dose regimen against Engerix-B in patients from 11 to 55 years of age.
Dynavax 称，他们计划将进行二次给药方式的申报批准工作，并且在年底前在欧洲、加拿大和美国启动3期临床试验，与Engerix-B对年龄11到55岁的患者进行二次给药的对照性研究。
These trials are expected to be completed in 2008.
该试验预计2008年完成。
Shares of Dynavax, which closed at $7.40 on Nasdaq, rose to $9.80 in after hours trading.
在宣布后几小时交易中，Dynavax公司的股票由$7.40 飙升至 $9.80 。
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作者:admin@医学,生命科学 2010-09-24 05:11
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