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临床试验 一期临床试验疱疹
Novel, Multi-Valent, HSV-2 Therapeutic Vaccine Generates CD4 + and CD8 + Immune Responses
小说，多价，单纯疱疹病毒2治疗性疫苗产生的CD4 +和CD8 +免疫反应 SALT LAKE CITY--(BUSINESS WIRE)--Jul 27, 2010 - Antigenics (NASDAQ: AGEN) announced positive results with AG-707, an investigational therapeutic vaccine being developed to treat herpes simplex virus-2 (HSV-2), the virus that causes genital herpes, in infected patients.
盐湖城- （商业新闻） - 2010年7月27日- Antigenics（纳斯达克股票代码：阿根）宣布积极的结果与治疗的AG - 707，一种正在研究的治疗性疫苗正在研制单纯疱疹病毒2型（HSV - 2），生殖器疱疹病毒引起，在感染的病人。
Developed by Antigenics, the vaccine triggers a cellular immune response, stimulating both CD4 + and CD8 + T cells.
Antigenics开发的，该疫苗触发细胞免疫反应，刺激CD4 +和CD8 + T细胞。
“I believe these data represent the first finding of their kind in genital herpes treatments—showing a vaccine, AG-707, elicits both CD4 + and CD8 + T-cell responses in humans,” said David Koelle, MD, study investigator and professor of Medicine, Laboratory Medicine and Global Health Medicine, University of Washington.
“我相信这些数据代表了一种疫苗首次发现的一种治疗生殖器疱疹，显示，公司- 707，同时引出的CD4 +和CD8 + T细胞在人体的反应，”戴维说克勒，医师，研究者和教授医学，检验医学与全球医药保健，华盛顿大学。
"We are very encouraged by these results. Recent data suggest both of these arms of immunity are needed for successful treatment of genital herpes.”
“我们非常鼓舞，这些结果。最近的数据显示免疫双臂这些都需要生殖器疱疹治疗成功的。”
Data will be presented at the International Herpes Workshop annual meeting in Salt Lake City, Utah, on July 27 by study investigator, Dr. Koelle.
数据将提交湖城，犹他州，博士克勒7月27日通过调查研究，在国际疱疹研讨会年会在盐。
The full data will be submitted for publication in a peer-reviewed journal.
完整的数据将被提交出版同行评议的期刊。
“The obvious potential of AG-707 is in managing outbreaks and disease transmission in patients with genital herpes,” added Koelle.
“该- 707明显是潜在的公司在管理疱疹与生殖器暴发和传播的疾病的患者补充说：”克勒。
“Being able to impact and possibly decrease the spread of genital herpes would be a huge step in stemming this epidemic.”
“能够影响和可能减少生殖器疱疹的传播将是一个巨大的一步，这种流行病引起的。”
“These results represent proof of concept for our proprietary off-the-shelf infectious disease platform.
“这些结果代表平台传染病的概念，证明我们的专利现成的，货架。
Based on our technology of integrating heat shock proteins with antigenic peptides, we could potentially create therapeutic vaccines for many infectious diseases.
基于我们的技术，蛋白质肽与热休克抗原结合，我们有可能创造传染性疾病对许多治疗性疫苗。
Our next step is to engage a partner to advance the clinical development of AG-707 in genital herpes and to pursue the broader application of the platform technology,” added Garo Armen, PhD, Antigenics chairman and CEO.
我们的下一个步骤是进行一个合作伙伴，推进临床开发的AG - 707的生殖器疱疹，追求更广泛的平台技术的应用，补充说：“加罗阿尔缅，博士，Antigenics公司董事长兼首席执行官。
STUDY RESULTS
研究结果 In this four-arm, phase 1 study, 35 HSV-2 seropositive patients received AG-707+QS-21 Stimulon ® adjuvant (Antigenics proprietary saponin adjuvant), AG-707 alone, QS-21 alone, or placebo.
在这四臂，第1阶段的研究，35的HSV - 2阳性患者的AG - 707 +的QS - 21 Stimulon ®佐剂（Antigenics专有皂素佐剂），公司- 707单独的QS - 21单独或安慰剂。
Patients received three treatments at two-week intervals. The vaccine was well tolerated, with injection site pain as the most common reported adverse event.
患者接受治疗3个星期的时间间隔在两。疫苗耐受性良好的，注射部位疼痛的最常见的不良事件。
All patients who were evaluable for immune response and received AG-707 with QS-21 showed a statistically significant CD4 + T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response (63%; 5/8).
所有患者谁是评价疗效的免疫和获得的QS - 21的AG - 707的显示显着的CD4 + T细胞的反应（100％，7 / 7）对HSV - 2酶联免疫斑点抗原³作为检测伊夫尼，和那些大多数患者表现出了CD8 + T细胞的反应（63％，5 / 8）。
This study is the first to demonstrate that heat shock proteins complexed to viral antigens induce an antigen-specific T cell response in humans.
这项研究首次证明，热休克蛋白络合病毒抗原诱导抗原特异性T细胞在人体的反应。
ABOUT HERPES
关于疱疹 According to the Centers for Disease Control, genital herpes affects more than 60 million Americans—or 1 in 6 people between ages 14 and 49—with an additional 1.5 million new cases each year. 1 This disease normally results in 6 outbreaks per year, but in severe cases more episodes may result. 2 The psychosocial consequences of genital herpes are quite significant, as 57 percent of those infected indicated that herpes had interfered with their sexual relationships, 50 percent felt it was difficult to live with genital herpes, and 37 percent felt that herpes had ruined their lives. 3 Additionally, ongoing research indicates an increasing resistance to currently available genital herpes treatments.
据美国疾病控制中心，生殖器疱疹的影响超过6000万美国人或1 6 1人年龄介乎14和49与增发了150宗个案万新的一年。这种疾病，但通常的结果，每6年爆发在严重情况下可能会导致更多的发作。2生殖器疱疹的心理后果是相当巨大的，百分之57的感染者表示，疱疹干扰了他们的性关系，百分之五十认为这是难以生存与生殖器疱疹，和百分之37认为，疱疹已经毁了他们的生活。 三此外，正在进行的研究表明，越来越耐治疗生殖器疱疹目前可用。
ABOUT AG-707
关于AG - 707 AG-707 is an off-the-shelf therapeutic vaccine for the treatment of genital herpes, which is caused by the herpes simplex virus-2 (HSV-2).
的AG - 707是一种现成的，现成2）治疗性疫苗可用于治疗生殖器疱疹，这是由单纯疱疹病毒2型（HSV。
The vaccine is based on Antigenics' heat shock protein (HSP) platform technology.
该疫苗是基于Antigenics'热休克蛋白（HSP）的平台技术。
Heat shock proteins (HSPs), also called stress proteins, are found in all cells (normal cells, cancer cells and infected cells) and recent research has demonstrated that HSPs play an essential role in the presentation of pieces of proteins (or peptides) on the cell surface to help the immune system recognize diseased cells.
热休克蛋白（HSPs），也称为应激蛋白，是细胞中发现，在所有细胞（正常，肿瘤细胞和感染细胞）和最近的研究表明，热休克蛋白肽发挥）的一个重要的角色提出了件蛋白（或在细胞表面，以帮助免疫系统识别病变细胞。
While the initial focus of development has been in HSV-2, the HSP technology platform can potentially be utilized for off-the-shelf treatment of many types of infectious diseases such as HPV, HIV, hepatitis, malaria and tuberculosis.
虽然最初的重点发展有2个在单纯疱疹病毒，热休克蛋白的技术平台有可能被用于现成的，现成的传染性疾病的治疗多种类型，如人乳头状瘤病毒，艾滋病毒，肝炎，疟疾和结核病。
AG-707 consists of recombinant human heat shock protein-70 complexed with 32 distinct 35-mer synthetic peptides from the HSV-2 proteome.
的AG - 707包括重组人热休克蛋白70与32不同的蛋白质络合35 - 2 Mer的合成肽的单纯疱疹病毒。
This broad spectrum of herpes antigens is intended to allow for more accurate immune targeting and surveillance, reducing the likelihood of immune escape.
这种疱疹广泛逃脱抗原是为了让更多的准确定位和免疫监视，免疫的可能性减少。
Further, the diversity of antigens in AG-707 increases the chance of providing efficacy for a wide segment of the patient population.
此外，增加多样性707抗原在公司，都是人口机会病人疗效提供了一个广泛的领域。
ABOUT QS-21
关于我们的QS - 21 QS-21 is a vaccine adjuvant designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective.
的QS - 21是一种疫苗佐剂，以增强人体的免疫应答的疫苗的抗原，从而使之更为有效。
QS-21 has become a critical component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders.
的QS - 21已成为传染病预防中的重要组成部分的发展正在研究的疫苗制剂品种的跨宽，似乎是必要的治疗癌症疾病和退行性几个研究性治疗性疫苗的打算。
Currently, QS-21 is being studied in clinical trials in approximately 15 vaccine indications, of which several are in late-stage clinical trials by Antigenics' licensees, including GlaxoSmithKline and Janssen Alzheimer Immunotherapy, a wholly owned subsidiary of Johnson & Johnson.
目前的QS - 21是正在研究在临床试验中，在大约15个疫苗迹象，其中几个阶段的后期临床试验和约翰逊所Antigenics'的授权，包括葛兰素史克和詹森约翰逊附属免疫治疗阿尔茨海默氏症，一间全资拥有。
ABOUT ANTIGENICS
关于ANTIGENICS Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases.
Antigenics（纳斯达克：阿根）是一家生物技术公司合作开发治疗癌症及其他疾病的传染。
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