伍珀塔尔,德国,7月18日,2011 / B3C通社 / -第二阶段结果
AiCuris“新型非nucleosidic的单纯疱疹病毒(HSV)抑制剂AIC316揭示生殖器疱疹的人的安全性和有效性。
The data were presented at the 19 th ISSTDR Meeting (International Society for Sexually Transmitted Diseases Research) in
数据在19
日 ISSTDR会议(性病研究国际学会)
Quebec
魁北克
,
,
Canada
加拿大
, by the coordinating investigator of the trial, Professor Anna Wald from the
,协调研究者的审判,从安娜·沃尔德教授
University
大学
of
的
Washington
华盛顿
and
和
Fred
弗雷德
Hutchinson
哈钦森
Cancer
癌症
Research
研究
Center
中心
in
在
Seattle
西雅图
,
,
USA
美国。
156 HSV-2 positive participants (105 women and 51 men) were randomized between May 2010 and October 2010 at seven sites in the
156 HSV-2(105名妇女和51名男性)的积极参与者,2010年5月至2010年10月随机在七个地点
US
美国
.
。
The goal of the trial was to compare the efficacy of four different doses of AIC316 (5, 25, and 75 mg once daily, or 400 mg once weekly) and placebo with respect to the suppression of HSV shedding.
该试验的目的是比较四种不同剂量的AIC316(5日,25日和75毫克,每天一次,或每周一次400毫克)和安慰剂的疗效,抑制单纯疱疹病毒脱落。
All participants received the study drug or placebo daily or weekly for 4 weeks.
所有与会者都收到研究药物或安慰剂,每天或每周4周。
AIC316 was safe and well tolerated at all doses administered and led to a significant reduction of viral shedding in a dose dependent manner.
AIC316是安全的,以及在管理和领导的剂量依赖性显着减少的病毒脱落的所有剂量的耐受性。
The strongest treatment effect was seen in the 400 mg once weekly and the 75 mg once daily dosing groups.
被视为在400毫克,每周一次75毫克,每日一次给药组最强的治疗效果。
Moreover, AIC316 led to a significant reduction of the amount of HSV found.
此外,AIC316导致的单纯疱疹病毒的发现量显着减少。
This highly suppressive effect of AIC316 on viral replication also correlated with a significant clinical benefit: the proportion of days with reported genital lesions was reduced from 13,7 % to 1,1 %; the number of recurrences was substantially reduced as well.
这AIC316高度抑制病毒复制的效果也具有显着的临床益处:天的比例从13.7%降低到1,1%报生殖器病变复发的数量大幅减少,以及相关。
”We are very pleased with these data as HSV therapy has not seen much innovation in more than a decade.
“我们很高兴与这些数据作为单纯疱疹病毒治疗还没有看到多少创新,在十年以上。
Our data confirm an excellent antiviral efficacy in humans, a clear dose response and an overall good safety profile.
我们的数据证实,在人类优秀的抗病毒疗效,一个明确的剂量反应和整体良好的安全性。
The innovative trial design that used shedding was important to show clearly the benefit of our drug and identify doses for further development”, says Prof. Helga Rübsamen-Schaeff, CEO at AiCuris.
教授,,海尔格RübsamenSchaeff,在AiCuris首席执行官说,创新的试验设计,使用脱落重要的是清楚地表明我们的药品的利益,并确定剂量的进一步发展“。
“The significant clinical benefit of reduced lesions and recurrences combined with a good safety profile are very encouraging for the further development of our drug” adds Dr. Marie-Paule Richard, CMO at AiCuris.
结合具有良好的安全性病变和减少复发的显着的临床效益,为进一步发展我们的药物是非常令人鼓舞的“玛丽 - Paule理查德博士补充说,奇美在AiCuris。
About HSV
关于单纯疱疹病毒 Herpes simplex viruses (HSV) are widespread in the human population (seroprevalence up to 100 %, depending on geographic area and population), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2).
单纯疱疹病毒(HSV)的广泛的人口(血清阳性率高达100%,根据地域面积和人口),分为单纯疱疹病毒1型(HSV-1)和2型(HSV-2)。
While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly transmitted sexually.
虽然HSV-1主要引起口腔溃疡,生殖器区域(唇疱疹),HSV-2舱单,主要是通过性传播。
However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries.
然而,过去十年来的HSV-1生殖器感染,现在至少有一半在一些国家,生殖器疱疹的首次发作的增加。
Both oral and genital herpes are generally self-limiting but can recur frequently.
无论是口腔和生殖器疱疹是一般自限性,但可以经常发生。
HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV.
单纯疱疹病毒感染也已与在性收购艾滋病毒的风险增加三倍。
In immunocompromised persons large and painful ulcerations may result, and newborns infected with HSV are at risk of dying from the infection.
大和痛苦的溃疡,可能导致免疫功能低下者,与单纯疱疹病毒感染的新生儿感染死亡的危险。
Currently available herpes drugs share the same mode of action, ie inhibition of a viral enzyme, the DNA polymerase.
目前可用疱疹的药物有着同样的行动模式,即抑制病毒的酶,DNA聚合酶。
They are similar in efficacy and may exhibit cross-resistance.
他们有相似的疗效,并可能会出现交叉耐药性。
Unlike these widely used current drugs, AIC316 acts by a separate and unique mechanism of viral inhibition and hence is also active against resistant virus.
不同于这些目前广泛使用的药物,AIC316由单独的和独特的机制抑制病毒的行为,因此也积极对抗药性的病毒。
About AiCuris
关于AiCuris AiCuris GmbH & Co KG, is a privately held company located in
AiCuris有限两合公司,是一家私人控股公司,位于
Wuppertal
伍珀塔尔
,
,
Germany
德国
.
。
It is devoted to research and clinical development of novel, resistance-breaking drugs for the treatment of HCMV, Herpes, Hepatitis B, HIV and Hepatitis C as well as resistant Gram positive and Gram negative bacterial infections in hospitals.
它是专门研究和临床开发的新型,耐破人巨细胞病毒,疱疹,乙肝,艾滋病毒和丙型肝炎以及抗革兰氏阳性和革兰氏阴性细菌医院感染的治疗药物。
Furthermore, the portfolio comprises two immune modulators.
此外,该产品组合包括两种免疫调节剂。