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发表于 2015-11-1 19:51 |只看该作者

ARC-520 inhibited cccDNA-derived mRNA with protein knockdown up to 99%...

Arrowhead Late-Breaker Abstract Accepted for Presentation at the AASLD Liver Meeting 2015

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that additional clinical data on ARC-520, its RNAi therapeutic candidate for the treatment of chronic hepatitis B infection, will be presented in the late-breaking poster session at The Liver Meeting® 2015, the 66th Annual Meeting of the American Association for the Study of Liver Disease (AASLD) being held on November 13-17, 2015, in San Francisco.

The late-breaking abstract details results from the Heparc-2001, Phase 2 study of ARC-520 in combination with entecavir (ETV). Key findings include the following:

    Naïve patients reduced viral DNA up to 4.3 log (mean 2.2 log)
    Naïve e-antigen (HBeAg) positive patients reduced surface antigen (HBsAg) up to 1.9 log (mean max 1.1 log)
    ARC-520 reduced HBeAg up to 1.7 log (mean max 1.2 log)
    ARC-520 therapy was well tolerated with no adverse events rated serious, severe, drug-related or causing withdrawal from the trial
    15 patients are continuing in follow-up and additional results may be available to report at The Liver Meeting

Christopher Anzalone, Ph.D., president and CEO of Arrowhead, said, "In the Phase 2 study, ARC-520 effectively inhibited cccDNA-derived mRNA with protein knockdown up to 99% or 1.9 logs observed. This is the highest knockdown ever reported using RNAi in humans. Our clinical program and our study in chronically infected chimps continue to teach us a lot about HBV and we are thrilled to get the opportunity to make three presentations at The Liver Meeting next month."

With the addition of the late-breaking poster, Arrowhead has the following three abstracts accepted for presentation at the Liver Meeting:

November 15, 3:15 p.m. PST - Christine Wooddell, Ph.D., group leader will deliver an oral presentation titled, "Reductions in cccDNA under NUC and ARC-520 therapy in chimpanzees with chronic hepatitis B virus infection implicate integrated DNA in maintaining circulating HBsAg"

November 16, 8:00 a.m. - 5:30 p.m. PST - Man-Fung Yuen, M.D., Ph.D., chair of gastroenterology and hepatology, The University of Hong Kong, and deputy chief of service, Queen Mary Hospital department of medicine, Hong Kong, will deliver a late-breaking poster presentation titled, "ARC-520 produces deep and durable knockdown of viral antigens and DNA in a phase II study in patients with chronic hepatitis B"

November 17, 8:00 a.m. - 12:00 p.m. PST - Christine Wooddell, Ph.D., group leader will deliver a poster presentation titled, "Monthly dosing of ARC-520 in chronically hepatitis B virus infected chimpanzees produces rapid, deep and durable reductions in circulating viral antigens"

Additional details including presentation abstracts can be found on the AASLD website by clicking this link. A copy of presentation materials can be accessed by visiting the Events section of the Arrowhead website after the presentations conclude.

About ARC-520

Arrowhead's RNAi-based candidate ARC-520 is being investigated in the treatment of chronic HBV infection. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. Arrowhead has completed a Phase 1 single ascending dose study in normal volunteers and the company is conducting single dose Phase 2a studies and multiple dose Phase 2b studies in chronic HBV patients. Approximately 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

About Arrowhead Research Corporation

Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate™ delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead's pipeline includes ARC-520 and ARC-521 for chronic hepatitis B virus, ARC-AAT for liver disease associated with alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and thromboembolic diseases, and ARC-HIF2 for renal cell carcinoma.

For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadresearch.com/alerts.cfm.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research Corporation.

The Liver Meeting is a registered trademark of the American Association for the Study of Liver Disease.

Source: Arrowhead Research Corporation

View source version on businesswire.com: http://www.businesswire.com/news/home/20151020005585/en/

Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
[email protected]
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Chad Rubin, 646-378-2947
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Source: Arrowhead Research Corporation

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发表于 2015-11-1 20:17 |只看该作者

ARC520... Based on the current situation, the FDA approval is in late 2018

Based on the current situation, we estimate top line data from the Phase IIb trial will be available in mid-2006. We expect Arrowhead will be able to initiate pivotal Phase III trial of ARC-520 in late 2016, and data should be available in mid-2017. NDA could be filed in late 2017, and the FDA approval is in late 2018.
Don't waste precious energy on gossip, energy vampires, issues of the past, negative thoughts or things you cannot control. Instead invest your energy in the positive present moment.
别把宝贵的精力浪费在流言蜚语、白耗精力的事情、过去的问题、消极的想法或你不能控制的事情上,而是把精力放在积极的当下。

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1173
发表于 2015-11-1 20:17 |只看该作者
箭头晚断路器摘要在AASLD肝病会议2015年接受演示

加利福尼亚州帕萨迪纳 - (BUSINESS WIRE) - 箭头研究公司(纳斯达克股票代码:ARWR),一家生物制药公司开发有针对性的RNA干扰疗法,今天宣布,ARC-520更多的临床数据,RNA干扰治疗的候选人为慢性肝炎的治疗病毒感染,就会在肝脏Meeting®2015年了最新的海报会议上提出,对肝病的研究的美国协会(AASLD)第66届年会举行的11月13号至17号,2015年在旧金山。

从Heparc-2001的后期破抽象的细节效果,ARC-520与恩替卡韦(ETV)组合2期研究。主要调查结果包括以下内容:

    初治患者为4.3日志减少病毒DNA向上(平均2.2日志)
    朴素电子抗原(HBeAg)阳性的患者减少了表面抗原(HBsAg)达1.9日志(平均最大1.1日志)
    ARC-520的HBeAg降低至1.7日志(平均最大1.2日志)
    ARC-520治疗的耐受性良好,额定严重,严重,药物相关或造成撤出试验无不良事件
    15例患者继续在跟进和额外的结果可能提供肝脏会议报告

克里斯托弗Anzalone,箭头的博士,总裁兼首席执行官说,“在第2阶段的研究中,ARC-520有效抑制cccDNA的衍生基因与蛋白质击倒高达观察到99%或1.9日志,这是有史以来最高的击倒报道在人类使用RNA干扰。我们的临床方案和我们在慢性感染的黑猩猩研究继续教我们很多关于乙肝病毒,我们很高兴能有机会进行三次演讲在肝脏会议下个月。“

随着加入的最新海报,箭头已接受演讲在肝脏会议在以下三个摘要:

11月15日,下午3:15 PST - 恭Wooddell,博士,组长将黑猩猩的慢性乙肝病毒感染株连整合的DNA提供一个口头报告题为“在cccDNA的排量下NUC和ARC-520治疗维持循环乙肝表面抗原“

11月16日,上午8:00 - 下午5:30 PST - 满凤园,医学博士,胃肠病和肝病的主席,香港大学,和服务的副主任,玛丽医院内科,香港,将提供了最新的海报展示名为“ARC-520产生病毒抗原和DNA的深刻而持久的击倒在II期临床试验治疗慢性乙型肝炎”

11月17日8:00 - 下午12点PST - 恭Wooddell,博士,组长将提供一个海报展示名为“ARC-520在慢性乙肝病毒感染的黑猩猩每月给药产生快速,深耐用减少循环的病毒抗原“

更多信息演示文稿摘要可在AASLD网站上点击链接可以找到。介绍材料的副本可通过访问箭头网站的活动部分的发言总结后进行访问。

关于ARC-520

箭头的基于RNAi的候选ARC-520正在调查慢性HBV感染的治疗。小干扰RNA(siRNA)的ARC-520介入在mRNA水平,反转录过程,其中护理核苷酸的目前标准和核苷类似物起作用的上游。箭头正在调查的ARC-520特异性以确定它是否可用于实现一个功能治愈,这是其特征在于,乙肝表面抗原阴性血清有或没有血清转化的免疫clearant状态。箭头已经完成了正常的志愿者一期单剂量递增研究,该公司正进行单剂量2a期研究和多次给药阶段2b研究在慢性乙型肝炎患者。全世界大约350-400百万人慢性感染了乙肝病毒,它可导致肝硬化并负责全球80%的原发性肝癌。

关于箭头研究公司

箭头研究公司是一家生物制药公司,开发有针对性的RNAi疗法。该公司利用其专有的动态Polyconjugate™传输平台开发基于能够有效地沉默致病基因RNA干扰机制的靶向药物。箭头的管道包括ARC-520和ARC-521为慢性乙型肝炎病毒,ARC-AAT用于与α-1抗胰蛋白酶缺乏,ARC-F12为遗传性血管水肿和血栓栓塞性疾病,和ARC-HIF2为肾细胞癌相关的肝脏疾病。

欲了解更多信息,请访问http://www.arrowheadresearch.com,或关注我们的微博@ArrowRes。要添加到公司的电子邮件列表,并直接收到的消息,请访问http://ir.arrowheadresearch.com/alerts.cfm。

美国私人证券诉讼改革法案的安全港声明:

本新闻稿中包含的1995年。这些声明的私人证券诉讼改革法案中有关“安全港”条文所界定的前瞻性声明是基于我们目前的预期,仅截至本新闻稿发布日的发言。公司的实际业绩可能会与不利所表达的任何前瞻性陈述的各种因素和不确定性,包括我们资助我们的业务,我们的能力,成功开发候选药物的能力,我们的科学研究的未来的成功结果,启动和完成临床试验,在我国市场的快速技术变革的时机,以及我们的知识产权执法。的Form 10-Q表格10-K和其后的季度报表箭头研究公司的最新年度报告讨论了一些可能会影响我们的业务,经营及财务状况造成的重要危险因素。我们不承担更新或修改前瞻性声明以反映新的事件或情况。

动态POLYCONJUGATES是箭头研究公司的商标。

肝脏会议是美国协会为肝脏疾病的研究的注册商标。

资料来源:箭头研究公司

在businesswire.com查看源代码版本:http://www.businesswire.com/news/home/20151020005585/en/

箭头研究公司
文斯Anzalone,CFA
626-304-3400
[email protected]
要么
投资者关系:
鳟鱼集团
乍得鲁宾,646-378-2947
[email protected]
要么
媒体:
日俄合作伙伴
马特中间人,医学博士
212-845-4272
[email protected]

资料来源:箭头研究公司

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发表于 2015-11-1 20:37 |只看该作者
回复 scilab 的帖子

如果按箭头还在澳洲进行的二期的话,那要到17年底才能完成二B啊;但愿美国那个二B、和德国的二B完成后,16年中后期就可以全球推开三期(包括大陆、香港和台湾)若果大陆能挣取16年来大陆做三期临床试验的话,我想1亿的HBV都会挺GCD的,那就GCD一统江湖,天秋万代了

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发表于 2015-11-1 21:34 |只看该作者
看了arc520,tkm-hbv,安进pdf论文,老鼠,大猩猩试验,打了几针后,过了一段后hbsag都反弹了,有点担心

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发表于 2015-11-1 22:08 |只看该作者
newchinabok 发表于 2015-11-1 21:34
看了arc520,tkm-hbv,安进pdf论文,老鼠,大猩猩试验,打了几针后,过了一段后hbsag都反弹了,有点担心 ...

悲伤呀惶恐
建议有实力的众筹基金会,十亿元级以上,真劝慰雷军、地产商、首富、百度,强生战略入股,全球重金悬赏求拜攻克乙肝的美国古巴专家英才及技术!!齐参与、正能量,或许好药就在转角间被发现,如果没有?就用真实去验证及考证中草药民间名医,延长寿命
嘤其鸣矣,求其友声! 相彼鸟矣,犹求友声;矧伊人矣,不求友生?神之听之,

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发表于 2015-11-2 17:19 |只看该作者
回复 newchinabok 的帖子

求科普!

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发表于 2015-11-2 19:53 |只看该作者
本帖最后由 tonychant 于 2015-11-2 19:56 编辑
newchinabok 发表于 2015-11-1 21:34
看了arc520,tkm-hbv,安进pdf论文,老鼠,大猩猩试验,打了几针后,过了一段后hbsag都反弹了,有点担心 ...

一转眼一年又过去了,看看2014年底憧憬,一次又一次的希望,一次又一次地失望,直至绝望,人类可以发明计算机这么先进的东西,而HBV为何就不能被打败呢?

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风雨同舟

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发表于 2015-11-2 22:43 |只看该作者
所以需要核苷类药物和干扰素联用,激活免疫,降低病毒载量。
日行一善(百善孝为先)

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发表于 2015-11-2 22:45 |只看该作者
回复 tonychant 的帖子

用不着这样吧,良好的心态其实也和药一样重要!
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