15/10/02说明:此前论坛服务器频繁出错,现已更换服务器。今后论坛继续数据库备份,不备份上传附件。

肝胆相照论坛

 

 

肝胆相照论坛 论坛 学术讨论& HBV English Arrowhead Pharmaceuticals Presents ARC-520 Clinical ...
查看: 2010|回复: 10
go

Arrowhead Pharmaceuticals Presents ARC-520 Clinical Data at The International [复制链接]

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
1
发表于 2018-4-12 21:49 |只看该作者 |倒序浏览 |打印
Arrowhead Pharmaceuticals Presents ARC-520 Clinical Data at The International Liver Congress™
Apr 11, 2018 at 7:00 AM EDT
PASADENA, Calif. --(BUSINESS WIRE)--Apr. 11, 2018-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the presentation of clinical data on ARC-520, the company’s prior generation investigational medicine for the treatment of chronic hepatitis B infection, at The International Liver

PASADENA, Calif.--(BUSINESS WIRE)--Apr. 11, 2018-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the presentation of clinical data on ARC-520, the company’s prior generation investigational medicine for the treatment of chronic hepatitis B infection, at The International Liver Congress™ 2018 (ILC), the annual meeting of the European Association for the Study of the Liver (EASL). An ePoster with these data is now available at ILC and on the company’s website.

The poster presentation includes follow-up data for patients enrolled in the Heparc-2001 multi-dose extension study. In the study, 8 chronic hepatitis patients (5 HBeAg-negative, 3 HBeAg-positive) received up to 9 doses of 4 mg/kg ARC-520 once every 4 weeks with daily entecavir (ETV). Viral DNA, RNA, and antigen knockdown were measured at regular intervals. Patients continued their daily ETV and were monitored for an additional 12 months following the last ARC-520 dose.

Key results include the following:

One HBeAg-negative patient serocleared HBsAg post ARC-520
Mild ALT changes off ARC-520 therapy coincided with sustained host responses in 2/3 HBeAg-positive and 2/5 HBeAg-negative patients
A single dose of ARC-520 in combination with ETV reduced HBsAg for up to 44 weeks
Multiple doses of ARC-520 resulted in additional HBsAg reductions in all patients by as much 5.3 Log10
ARC-520 in combination with ETV was effective at rapidly suppressing HBV DNA
Poster Presentation Details:

RNA interference therapy with ARC-520 Injection results in long term off-therapy antigen reductions in treatment naïve, HBeAg positive and negative patients with chronic HBV

Presentation Reference: FRI-362
Session: Viral hepatitis B/D: Therapy
Session Date and Time: April 13, 2018 from 9 a.m. to 5 p.m. CET
Authors: Man-Fung Yuen, et al.
Additional details, including the presentation abstract, can be found on the ILC website at https://ilc-congress.eu/. A copy of presentation materials can be accessed by visiting the Events section of the Arrowhead website.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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

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 the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, 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. Our 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 Pharmaceuticals, Inc.



View source version on businesswire.com: https://www.businesswire.com/news/home/20180411005375/en/

Source: Arrowhead Pharmaceuticals Inc.

Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
[email protected]
or
Investors and Media:
LifeSci Advisors, LLC
Brian Ritchie, 212-915-2578
[email protected]
www.lifesciadvisors.com

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
2
发表于 2018-4-12 21:49 |只看该作者
箭头制药礼物arc - 520临床数据在国际肝脏国会™
2018年4月11日,美国东部时间晚上7点
加州帕萨迪纳市——(业务线)——4月。 2018——箭头制药有限公司(纳斯达克:ARWR)今天宣布临床数据的表示弧- 520,该公司的前一代临床实验的药物治疗慢性乙型肝炎的感染,在国际肝脏

加州帕萨迪纳市——(业务线)——4月。 2018——箭头制药有限公司(纳斯达克:ARWR)今天宣布临床数据的表示弧- 520,该公司的前一代临床实验的药物治疗慢性乙型肝炎的感染,在国际肝脏国会™2018(ILC)年会的欧洲肝脏研究协会(EASL)。 与这些数据现在可以在ILC ePoster和该公司的网站上。

海报展示包括heparc病人的随访数据- 2001多剂量扩展研究。 在这项研究中,慢性肝炎患者8(5 HBeAg-negative 3 HBeAg-positive)收到多达9支4毫克/公斤arc - 520每隔4周日常恩替卡韦(ETV)。 病毒DNA、RNA和抗原可拆卸的定期测量。 患者持续监控他们的日常ETV和额外的12个月后最后arc - 520剂量。

主要结果包括以下:

一个HBeAg-negative病人serocleared HBsAg arc - 520
温和的ALT改变了arc - 520治疗伴随着持续的宿主反应2/3 HBeAg-positive和2/5 HBeAg-negative病人
单一剂量的arc - 520结合ETV HBsAg 44周减少
多剂量的arc - 520导致额外的乙肝表面抗原在所有患者减少了5.3 Log10
arc - 520结合ETV迅速有效地抑制乙肝病毒DNA
海报展示细节:

RNA干扰治疗arc - 520注射导致长期off-therapy抗原减少治疗天真,e抗原阳性和阴性患者慢性乙肝病毒

报告参考:星期五- 362
会话:病毒性肝炎B / D:治疗
会议日期和时间:2018年4月13日,从早上9点到下午5点,CET(中央东部东京)
作者:Man-Fung袁,et al。
更多的细节,包括表示抽象,在ILC网站上可以找到https://ilc-congress.eu/。一份演讲材料可以通过参观访问活动的箭头的网站。

关于箭头制药

箭头制药发展药物治疗棘手的疾病通过沉默的基因使他们。 使用广泛的RNA组合化学和高效的方式交付,箭头治疗触发RNA干扰机制诱导迅速,深,耐用击倒目标基因。 RNA干扰、RNAi是一种机制存在于活细胞,抑制特定基因的表达,从而影响生产的一个特定的蛋白质。 箭头的RNAi-based疗法利用该基因沉默的自然途径。

有关更多信息,请访问www.arrowheadpharma.com,或者在Twitter上关注我们@ArrowheadPharma。 添加到该公司的电子邮件列表和直接接收的消息,请访问http://ir.arrowheadpharma.com/email-alerts

安全港声明下私人证券诉讼改革法案:

本新闻稿中包含前瞻性陈述的意义在“安全港”规定私人证券诉讼改革法案1995。 这些报表是基于我们当前的预期,只讲的日期。 我们的实际结果可能不同物质和负面的表达在任何前瞻性陈述由于各种因素和不确定性,包括我们产品的安全性和有效性的候选人,监管延迟的时间和影响我们的临床程序,我们财务业务的能力,未来的成功我们的科学研究,我们成功开发候选药物的能力,开始的时间和完成临床试验,快速的技术变化在我们的市场,我们的知识产权执法。 我们最近的年度报告形式10 - 10 - k和随后的季度报告形式讨论一些重要的危险因素,可能会影响我们的业务,业务和财务状况的结果。 我们假设没有义务更新或修订前瞻性陈述,以反映新的事件或环境。

来源:箭头制药公司。



查看源代码版本在businesswire.com上:https://www.businesswire.com/news/home/20180411005375/en/

来源:箭头制药公司。

箭头制药有限公司
文斯Anzalone,CFA
626-304-3400
[email protected]

投资者和媒体:
LifeSci Advisors LLC
布莱恩·里奇212-915-2578
[email protected]
www.lifesciadvisors.com

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
3
发表于 2018-4-12 21:51 |只看该作者
In the study, 8 chronic hepatitis patients (5 HBeAg-negative, 3 HBeAg-positive) received up to 9 doses of 4 mg/kg ARC-520 once every 4 weeks with daily entecavir (ETV). Viral DNA, RNA, and antigen knockdown were measured at regular intervals. Patients continued their daily ETV and were monitored for an additional 12 months following the last ARC-520 dose.

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
4
发表于 2018-4-12 21:52 |只看该作者
One HBeAg-negative patient serocleared HBsAg post ARC-520
Mild ALT changes off ARC-520 therapy coincided with sustained host responses in 2/3 HBeAg-positive and 2/5 HBeAg-negative patients
A single dose of ARC-520 in combination with ETV reduced HBsAg for up to 44 weeks
Multiple doses of ARC-520 resulted in additional HBsAg reductions in all patients by as much 5.3 Log10
ARC-520 in combination with ETV was effective at rapidly suppressing HBV DNA

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
5
发表于 2018-4-12 21:54 |只看该作者
sero cleare血清清除

Rank: 10Rank: 10Rank: 10

现金
20661 元 
精华
帖子
12793 
注册时间
2013-12-29 
最后登录
2024-11-3 
6
发表于 2018-4-12 21:56 |只看该作者
rnai药加免疫药,有治愈可能

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
7
发表于 2018-4-12 22:03 |只看该作者

Rank: 7Rank: 7Rank: 7

现金
6395 元 
精华
帖子
3365 
注册时间
2007-6-13 
最后登录
2023-2-10 
8
发表于 2018-4-18 22:47 |只看该作者
11月8日,深受业界期待、被大家寄予厚望的在研乙肝新药ARC-52O传来了坏消息。Arrowhead制药公司当天宣布,ARC-520的II期Heparc-2004研究被FDA完全暂停,意味着Arrowhead不能继续招募患者,当前已入组的患者须全部停药。原因是Arrowhead公司靶向肝脏的递送载体EX1在灵长类动物模型中出现了严重毒性问题,最高剂量(高于之前动物研究所用的剂量)下导致了不明原因的动物死亡。FDA并未明确指明叫停原因与人体临床试验有关。 ARC-520是一种RNA干扰疗法,通过特定序列siRNA来沉默乙肝病毒某些蛋白的表达,导致病毒无法增殖,再利用人体免疫系统对剩余病毒进行清除,实现免疫清洁状态,使得乙肝表面抗原(HBsAg)血清学转阴或消失,被认为具有功能性治愈乙肝的潜力,但至此也是前途未卜。

Rank: 6Rank: 6

现金
51 元 
精华
帖子
39 
注册时间
2018-3-14 
最后登录
2020-5-24 
9
发表于 2018-4-19 11:14 |只看该作者
回复 齐欢畅 的帖子

不是520不行,而是箭头有新药,不需要花大代价来取证520的病毒性。

Rank: 8Rank: 8

现金
887 元 
精华
帖子
807 
注册时间
2016-5-10 
最后登录
2024-3-31 
10
发表于 2018-4-19 11:23 |只看该作者
箭头的新药估计就是更先进的520和新的递送系统
‹ 上一主题|下一主题
你需要登录后才可以回帖 登录 | 注册

肝胆相照论坛

GMT+8, 2024-11-14 13:58 , Processed in 0.014359 second(s), 10 queries , Gzip On.

Powered by Discuz! X1.5

© 2001-2010 Comsenz Inc.