ARC-520

重韧

关键这个莫非赛定也没见能治好啊。。。

齐欢畅2

莫非赛定没了解过

wunaidewo

回复 newchinabok 的帖子

吃了核甘何能停药！太麻烦！干不试干碰运！

newchinabok

今天好像是股民起诉arwr关于arc520信息做假，不知官司如何？数据真不真？

StephenW

Arrowhead Files IND for RNAi Therapeutic ARC-520 to Begin Phase 2b Multiple-Dose Studies in Chronic Hepatitis B Patients


    PASADENA, Calif.--(BUSINESS WIRE)--      Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical      company developing targeted RNAi therapeutics, today announced that it      submitted an Investigational New Drug (IND) application to the U.S. Food      and Drug Administration for ARC-520, it's drug candidate for the      treatment of chronic hepatitis B virus (HBV) infection. Arrowhead plans      to submit additional clinical trial authorization applications with      regulatory authorities in various jurisdictions in Europe and Asia.   
          Pending national regulatory review and approval, Arrowhead intends to      initiate two Phase 2b, multicenter, randomized, double-blind,      placebo-controlled, multi-dose studies to determine the depth of      hepatitis B surface antigen (HBsAg) reduction following ARC-520      injection in combination with entecavir or tenofovir in patients with      chronic immune active HBV infection. The Heparc-2002 study is planned to      include patients who are negative for hepatitis B e-antigen (HBeAg) at      screening and the Heparc-2003 study is planned to include patients who      are positive for HBeAg at screening. The primary objective is to      evaluate the depth of HBsAg decline in response to multiple doses of      ARC-520 compared to placebo in patients with chronic HBV infection as a      measure of drug activity. Secondary objectives are to assess measures of      safety and tolerability and to evaluate multi-dose pharmacokinetics of      ARC-520 in patients with chronic HBV infection when co-administered with      a fixed dose of entecavir or tenofovir, in addition to other exploratory      safety and pharmacodynamic objectives.   
          "As with our recent application to begin a Phase 1 study with ARC-AAT,      this IND represents achievement of a key 2014 goal," said Arrowhead      President and CEO, Dr. Christopher Anzalone. "We look forward to      beginning multi-dose studies with ARC-520."   
          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 a single dose Phase 2a study 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 for chronic      hepatitis B virus, ARC-AAT for liver disease associated with Alpha-1      antitrypsin deficiency, and partner-based programs in obesity and      oncology.   
          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, actions of the U.S. Food and Drug Administration (FDA) and      similar global regulatory bodies, 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.   
          Source: Arrowhead Research Corporation   
   
  [img]https://ci3.googleusercontent.com/proxy/P4Av10_tbKgwSEIDk8aNe9pOA7up7CrKzgkUfhC623iuOxt25Iv0zubK-kDhVtHmLerf4EcVxspjmtRMwaxCa78TQQj6vZnOYANwuIvLNjRQYhF85Puxzg83g85YRDkdl-D07XHNUxQtGNdO21tNVJtp=s0-d-e1-ft#http://cts.businesswire.com/ct/CT?id=bwnews&sty=20141215005256r1&sid=acqr7&distro=nx&lang=en[/img]

          Arrowhead Research Corporation
Vince Anzalone, CFA, 626-304-3400
[email protected]
or
Investor      Relations:
The Trout Group
Lauren Glaser, 646-378-2972
[email protected]
or
Media:
Russo      Partners
Martina Schwarzkopf, Ph.D., 212-845-4292
[email protected]   
Source: Arrowhead Research Corporation

箭头文件IND为RNA干扰治疗ARC-520开始阶段2B多剂量研究慢性乙型肝炎患者


加利福尼亚州帕萨迪纳 - （美国商业资讯） - 箭头研究公司（NASDAQ：ARWR），一家生物制药公司，开发有针对性的RNAi疗法，今天宣布，它提交了一份研究性新药（IND）申请，美国食品和药物管理局ARC-520，它是候选药物用于治疗慢性乙型肝炎病毒（HBV）感染的治疗。箭头计划与监管部门在欧洲和亚洲的多个国家提交更多的临床试验许可申请。

等待国家监管部门的审查和批准，箭头打算启动二期2B，多中心，随机，双盲，安慰剂对照，多剂量研究，以确定乙肝表面抗原（HBsAg）减少深度以下的ARC-520注射液联合恩替卡韦和替诺福韦治疗慢性免疫激活HBV感染。该Heparc，2002年的研究计划，包括病人谁阴性乙肝e抗原（HBeAg）阳性的筛查和Heparc，2003年的研究计划，包括病人谁是积极为大三阳的筛选。的主要目的是评估响应于多剂量ARC-520与安慰剂相比在慢性HBV感染的药物活性的量度的HBsAg的下降深度。次要目标是评估安全性和耐受性的措施，并评价ARC-520的多剂量药代动力学在慢性HBV感染时共同施用恩替卡韦或替诺福韦的固定剂量，除其他试探性的安全性和药效的目标。

“正如我们最近的应用程序，开始第一阶段的研究与ARC-AAT，这种IND代表成就的一个关键目标，2014年，”箭头总裁兼首席执行官克里斯托弗·Anzalone博士说。 “我们期待着开始多剂量研究，ARC-520”。

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，其中护理核苷酸的当前标准和核苷类似物起作用的上游。箭头正在调查的ARC-520具体地，以确定它是否可用于实现一个功能的治疗，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，该公司正进行慢性乙肝患者单剂量2a期研究。全世界大约350-400百万人慢性感染的B型肝炎病毒，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™交付平台开发基于能够有效地沉默致病基因的RNA干扰机制的靶向药物。箭头的管道包括ARC-520慢性乙肝病毒，ARC-AAT与α-1抗胰蛋白酶缺乏症，和合作伙伴为基础的方案在肥胖和肿瘤相关的肝脏疾病。

欲了解更多信息，请访问http://www.arrowheadresearch.com，或关注我们的微博@ArrowRes。要添加到该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。

根据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“安全港”条文所界定的前瞻性陈述是基于我们当前的预期，仅截至本新闻稿发布日的讲话。我们的实际结果可能大不相同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运营，我们有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，美国食品和药物管理局（FDA）和类似的全球监管机构，在我们的市场的快速技术变革行动的时机，和我们的知识产权执法。在表格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。

来源：箭头研究公司

箭头研究公司
文斯Anzalone，CFA，626-304-3400
[email protected]
或
投资者关系：
鳟鱼集团
劳伦·格拉泽，646-378-2972
[email protected]
或
媒体：
日俄合作伙伴
玛蒂娜施华蔻，博士，212-845-4292
[email protected]

来源：箭头研究公司

tonychant

真心希望此药能拯救乙人，但是该公司的股价却不可思议的一直再跌，让乙人对这个2014年最大的期盼心里惴惴不安，神啊，救救乙人吧！

重韧

开始申请2B，最晚明年的11月美肝年会，520到底好不好用就知道了，

xiazhifeng0009

2A还没说怎么样

齐欢畅2

Arrowhead Files IND for RNAi Therapeutic ARC-520 to Begin Phase 2b Multiple-Dose Studies in Chronic Hepatitis B Patients

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for ARC-520, it's drug candidate for the treatment of chronic hepatitis B virus (HBV) infection. Arrowhead plans to submit additional clinical trial authorization applications with regulatory authorities in various jurisdictions in Europe and Asia.

Pending national regulatory review and approval, Arrowhead intends to initiate two Phase 2b, multicenter, randomized, double-blind, placebo-controlled, multi-dose studies to determine the depth of hepatitis B surface antigen (HBsAg) reduction following ARC-520 injection in combination with entecavir or tenofovir in patients with chronic immune active HBV infection. The Heparc-2002 study is planned to include patients who are negative for hepatitis B e-antigen (HBeAg) at screening and the Heparc-2003 study is planned to include patients who are positive for HBeAg at screening. The primary objective is to evaluate the depth of HBsAg decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic HBV infection as a measure of drug activity. Secondary objectives are to assess measures of safety and tolerability and to evaluate multi-dose pharmacokinetics of ARC-520 in patients with chronic HBV infection when co-administered with a fixed dose of entecavir or tenofovir, in addition to other exploratory safety and pharmacodynamic objectives.

"As with our recent application to begin a Phase 1 study with ARC-AAT, this IND represents achievement of a key 2014 goal," said Arrowhead President and CEO, Dr. Christopher Anzalone. "We look forward to beginning multi-dose studies with ARC-520."

齐欢畅2

good news ！说明箭头公司的成果是有效的，至少，大家不要太过苛责一家生物技术公司，因为生物技术的进步不是一蹴而就的，箭头已经非常不错了。我看好他们。