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标题: ISIS-HBV患者乙肝病毒感染的II期临床试验 [打印本页]

作者: newchinabok 时间: 2015-4-17 19:00 标题: ISIS-HBV患者乙肝病毒感染的II期临床试验

http://adisinsight.springer.com/trials/700254547

作者: newchinabok 时间: 2015-4-17 19:00

Trial Profile
Phase II trial of ISIS-HBVRx in patients with hepatitis B viral infection
Planning
Phase of Trial: Phase II
Latest Information Update: 10 Mar 2015
At a glance
Drugs ISIS HBVRx (Primary)
Indications Hepatitis B
Focus Therapeutic Use
Sponsors Isis Pharmaceuticals
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作者: newchinabok 时间: 2015-4-17 19:01

试用简介
ISIS-HBV患者乙肝病毒感染的II期临床试验
规划
审判阶段：第二阶段
最新的信息更新：2015年3月10日
一目了然
药物ISIS HBV RX（小学）
主治乙肝
聚焦治疗用药
赞助商伊希斯制药
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作者: 战天斗hbv 时间: 2015-4-17 20:25

推上这个药物提起的人很多、但是本版以前提起的很少

作者: newchinabok 时间: 2015-4-17 20:44

谈的不少，但大家更关注arc520

作者: 战天斗hbv 时间: 2015-4-17 20:52

newchinabok 发表于 2015-4-17 20:44
谈的不少，但大家更关注arc520

至少ARC520目前是有效果的、虽然”目前“的效果不足以单药搞定HBV、但前景很好、正所谓成王败寇、大家关注520多一些也是情理之中啊

作者: newchinabok 时间: 2015-4-17 20:56

Adis Insight数据库各种hbv研发药都知道进度，我提示的是isis-hbvrx进度

作者: zgct 时间: 2015-4-17 21:16

这个药哪里有详细资料

作者: zgct 时间: 2015-4-17 21:16

回复战天斗hbv 的帖子

推上怎样说的？

作者: newchinabok 时间: 2015-4-17 21:28

回复 zgct 的帖子

isis官网，反义药物比rnai药成熟十几年吧

作者: newchinabok 时间: 2015-4-17 21:28

http://ir.isispharm.com/phoenix. ... icle&ID=1911688

作者: newchinabok 时间: 2015-4-17 21:30

本帖最后由 newchinabok 于 2015-4-17 21:30 编辑

回复战天斗hbv 的帖子

你的特推东东说isis-hbv如何？

作者: newchinabok 时间: 2015-4-17 21:32

"Hepatitis B virus infection is a serious health problem that can lead to significant and potentially fatal health conditions, including cirrhosis, liver failure and liver cancer. Chronic HBV infection is one of the most common persistent viral infections in the world. Currently available therapies, although effective in reducing circulating HBV in the blood, do not efficiently inhibit HBV antigen production and secretion, which are associated with poor prognosis and increased risk of liver cancer," said Dr. Stefan Wieland, assistant professor of experimental virology at The Scripps Research Institute.  "These data are encouraging as they demonstrate that antisense drugs are able to efficiently reduce HBV-associated antigens as well as circulating HBV in an animal model of disease.  As such, these results provide support for the development of ISIS-HBVRx for the treatment of patients with chronic HBV infection."

These preclinical data, which will be presented by Dr. Gaetan Billioud from The Scripps Research Institute during a presentation on April 12 at EASL, demonstrate that antisense targeting of HBV RNA could be an effective approach to treating patients with chronic HBV infection.  In this study, an antisense compound targeting HBV produced dose-dependent reductions of HBV-associated antigens, including  HBsAg  (hepatitis B surface antigen), which is present in both acute and chronic infections and is associated with a poor prognosis in patients with chronic HBV infection.  In addition, other measures of viral infection were reduced in both the liver and serum in this mouse model of disease.

"While chronic hepatitis B virus is currently treated with oral antiviral agents or injectable interferons, these treatments do not clear HBV and do not effectively clear HBV antigens from these patients.  As a result, patients are unable to fully control HBV infection and achieve sustained disease remission.  Many of these patients are at elevated risk for severe liver complications such as cirrhosis and primary liver cancer.  By targeting and suppressing viral mRNAs in the liver, treatment with ISIS-HBVRx added to current therapies could result in greater viral inhibition and permit greater immune system activity against the virus," said Richard Geary, Ph.D., senior vice president, development at Isis. "Based on all of the preclinical data, including the animal data that will be presented at EASL, we initiated a Phase 1 study of ISIS-HBVRx late last year, which we plan to complete this year."

The Phase 1 study of ISIS-HBVRx is a randomized, placebo-controlled, dose-escalation study in approximately 30 healthy volunteers.  This study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of ISIS-HBVRx.  ISIS-HBVRx, formerly referred to as ISIS-GSK3Rx, is an investigational drug that is designed to target viral mRNA and reduce the production of viral proteins associated with HBV infection and replication.  ISIS-HBVRx is part of Isis' alliance with GSK.  Isis will develop ISIS-HBVRx to completion of Phase 2 proof-of-concept, after which GSK has an exclusive option to in-license and further develop and commercialize ISIS-HBVRx. Isis has already earned $10 million in milestone payments from GSK for ISIS-HBVRx and is eligible to earn additional pre-licensing milestone payments from GSK as ISIS-HBVRx advances in development.  Isis is also eligible to receive double-digit royalties on sales of ISIS-HBVRx.

ABOUT ISIS PHARMACEUTICALS, INC.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners.  Isis' broad pipeline consists of 31 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer.  Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in the United States and other countries for the treatment of patients with homozygous FH.  Isis' patents provide strong and extensive protection for its drugs and technology.  Additional information about Isis is available at www.isispharm.com.

ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding Isis' collaboration with GSK, the discovery, development, activity, therapeutic potential and safety of ISIS-HBVRx and the therapeutic potential of discovering a drug to treat chronic HBV infection.  Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2013, which is on file with the SEC. Copies of this and other documents are available from the Company.

In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.  KYNAMRO® is a registered trademark of Genzyme Corporation.

Logo - http://photos.prnewswire.com/prnh/20130807/LA60006LOGO

SOURCE Isis Pharmaceuticals, Inc.

For Isis Pharmaceuticals: D. Wade Walke, Ph.D., Vice President, Corporate Communications and Investor Relations, 760-603-2741, Amy Blackley, Ph.D., or Associate Director, Corporate Communications, 760-603-2772

作者: 战天斗hbv 时间: 2015-4-17 21:33

newchinabok 发表于 2015-4-17 21:30
回复战天斗hbv 的帖子

你的特推东东说isis-hbv如何？

推上也是更看好arc520、birinapant这两个、说实在的、我感觉老外确实对衣壳抑制剂兴趣不大

作者: newchinabok 时间: 2015-4-17 21:33

“乙型肝炎病毒感染是一个严重的健康问题，可导致显著和潜在致命的健康状况，包括肝硬化，肝功能衰竭和肝癌。慢性HBV感染是世界上最常见的持续性病毒感染的一种，目前可用的治疗，虽然有效地降低血液中的循环HBV，不能有效抑制HBV抗原的产生和分泌，这是与预后不良，增加肝癌的风险，“斯特凡·威兰博士，实验病毒学助理教授斯克里普斯研究所表示，。 “这些数据是令人鼓舞的，因为它们表明，反义药物能有效地降低的HBV相关抗原以及在疾病的动物模型循环的HBV，因此，这些结果对于ISIS-HBVRx的发展的治疗提供支持慢性HBV感染。“

这些临床前的数据，这将是加埃唐Billioud博士斯克里普斯研究所4月12日介绍，在EASL时出示，证明了反义RNA HBV的目标可能是一个有效的方法来治疗慢性HBV感染。在这项研究中，靶向的HBV的反义化合物所产生的剂量依赖性降低的乙型肝炎病毒相关抗原，包括的HBsAg（乙型肝炎表面抗原），这是目前在急性和慢性感染以及与不良预后的慢性HBV相关联感染。此外，还减少了在这两个中疾病的该小鼠模型中的肝脏和血清病毒感染的其他措施。

“虽然慢性乙型肝炎病毒目前与口服抗病毒剂或可注射的干扰素治疗，这些治疗没有明确HBV和执行从这些患者没有有效地清楚的HBV抗原。其结果是，患者无法完全控制HBV感染和实现持续病缓解。许多这些患者是在升高的风险为严重的肝脏的并发症，如肝硬化和原发性肝癌。通过在肝脏靶向并抑制病毒mRNA，用ISIS-HBVRx治疗加到目前的治疗方法可能会导致更大的病毒抑制和容许更大的针对该病毒的免疫系统的活动，“理查德·基尔博士，高级副总裁，发展的伊希斯说。 “基于所有的临床前数据，包括动物实验数据，将在EASL提交的，我们发起ISIS-HBVRx去年年底，我们计划完成今年的第1阶段的研究。”

ISIS-HBVRx的第一阶段研究是一项随机，安慰剂对照，剂量递增约30名健康志愿者的研究。这项研究旨在评估安全性，耐受性，以及单个和多个剂量的ISIS-HBVRx的药代动力学。 ISIS-HBVRx，以前称为ISIS-GSK3Rx，是一个研究药物被设计为靶向病毒mRNA，降低了生产与HBV感染和复制有关的病毒蛋白质。 ISIS-HBVRx是伊希斯“与GSK联盟的一部分。 ISIS将开发ISIS-HBVRx到第2阶段概念验证的完成，之后GSK拥有独家选择的许可，并进一步开发和商业化ISIS-HBVRx。伊希斯已经赚了1000万美元的里程碑付款从GSK的ISIS-HBVRx并有资格获得额外的预售许可的里程碑款项GSK为ISIS-HBVRx的发展进步。 ISIS也有资格获得两位数的特许权使用费在销售ISIS-HBVRx的。

作者: zgct 时间: 2015-4-17 22:07

回复战天斗hbv 的帖子

对，请问推上多讲了什么

作者: 战天斗hbv 时间: 2015-4-17 22:25

zgct 发表于 2015-4-17 22:07
回复战天斗hbv 的帖子

对，请问推上多讲了什么

认为其不如热门的几个药物、我继续看好birinapant

作者: crysalechain 时间: 2015-4-18 07:51

不管哪种药，希望它能快点脱颖而出，只要最终能彻底治愈，我就认为它最牛！

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