Tekmira制药公司开始I期试验HBV

StephenW

Tekmira Pharmaceuticals Corporation Begins Phase I HBV Trial
Posted By: Michelle JonesPosted date: January 21, 2015 12:27:58 PMIn: StocksNo Comments

Tekmira Pharmaceuticals announced this morning that it has begun the first phase of the clinical trial for its hepatitis B drug TKM-HBV. Shares of Tekmira edged upward by as much as 1% after the news was announced.

Tekmira Pharmaceuticals Corporation TKMR Stock
Tekmira reveals clinical trial

Although much of the buzz around the drug maker has been over its Ebola virus treatment, today’s announcement focuses on its hepatitis B drug. Several analysts have said in the last several months that investors should actually care more about this drug than about the Ebola treatment because the market for hepatitis B is likely bigger.

In today’s announcement, Tekmira said it has given the first dose to the first subject in the Phase 1 clinical trial of TKM-HBV. The drug maker describes the drug as a “therapeutic agent designed to reduce hepatitis B antigen in patients chronically infected with hepatitis B virus.”

The news comes in the same month as the announcement that Tekmira had reached an agreement to acquire OnCore Biopharma, another key player in hepatitis B treatments. OnCore brings multiple candidate drugs over to Tekmira.
Details on Tekmira’s drug trial

“We are pleased to have reached this important milestone, initiation of phase I studies with TKM-HBV,” said Tekmira President and CEO Dr. Mark Murray in a statement. “Since TKM-HBV represents our most important development program, we are testing two LNP formulations, generations three and four, of the product in this study. We expect the results to determine which product formulation we will advance into chronically infected patients later this year.”

The company described the Phase I clinical trial as a “randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV.” The goal of the study is to see how safe the drug is and how well patients are able to tolerate it. The drug is given intravenously.

Tekmira reported that 40 “healthy” adults are participating in the study, which covers both of the two formulations they are testing in the clinical trial. Four patients will be in each “cohort,” and three of them will receive the company’s hepatitis B treatment while the fourth will receive a placebo.

StephenW

Tekmira制药公司开始I期试验HBV
发布者：米歇尔JonesPosted日期：2015年1月21日12时27分58秒PMIN：StocksNo评论

Tekmira制药公司宣布，今天上午，该公司已经开始临床试验的第一阶段的乙肝药物TKM-HBV。 Tekmira股价向上小幅高达1％的消息宣布后。

Tekmira制药公司TKMR股票
Tekmira揭示临床试验

虽然很多周围的制药商的嗡嗡声一直在其埃博拉病毒的治疗，今天宣布的重点是其乙肝的药物。一些分析师已经在过去的几个月表示，投资者其实应该更关心这种药物比对埃博拉病毒治疗，因为市场对乙肝有可能更大。

在今天的公告中，Tekmira表示，它已经发出了第一剂量的TKM-HBV的1期临床试验的第一个主题。药物制造商描述药物为“旨在减少慢性感染乙肝病毒的患者乙肝抗原治疗剂。”

该消息是在同一个月的宣布Tekmira已经达成了一项协议，收购OnCore生物制药，另一个关键球员在乙肝的治疗。 OnCore过来Tekmira带来了多个候选药物。
对Tekmira的药物试验的细节

“我们很高兴达成这一重要的里程碑，I期与TKM-HBV研究开始，”Tekmira总裁兼首席执行官马克博士穆雷在声明中说。 “自从TKM-HBV代表了我们最重要的发展计划，我们将在这项研究中测试产品两个携号转网的配方，代三，四，。我们所期望的结果，以确定哪些产品配方，我们将提前进入慢性感染病人在今年晚些时候。“

该公司所描述的I期临床试验的“随机，单盲，安慰剂对照研究，涉及的单剂量递增TKM-HBV的。”该研究的目的是看如何安全的药物，以及如何好病人能够容忍它。该药物是静脉注射。

Tekmira报道，40“健康”成人参与研究，其中涵盖了两种配方，他们正在测试在临床试验中。四名病人将在每个“队列”，并且他们三人将获得该公司的乙肝治疗而第四将接受安慰剂。

重韧

看来上6月应该能出I期的A的结果。以这样的速度 ，二期不是要明年才能下。不知道到时候会不会加快速度 。现在Oncore 就已经基本上就是Tekmira了。

希望，健康

希望能根治，希望能实验成功。

newchinabok

FDA Pauses Testing Of Arrowhead’s (ARWR) Hepatitis B Drug
Arrowhead shares tanked 22% during Monday’s trading session on the announcement that the FDA had temporarily restricted further clinical testing on the company’s hepatitis-B treatment drug
ARWR







By: HANNAH ISHMAEL
Published: Jan 13, 2015 at 4:44 pm EST


Arrowhead Research Corp (NASDAQ:ARWR) saw its shares tank 22% during Monday’s trading session on the announcement that the US Food and Drug Administration (FDA) had restricted further clinical testing on the company’s hepatitis-B drug ARC-520, and announced a partial hold. The FDA said in a preliminary notification that Arrowhead was allowed to begin Phase IIb testing on the drug; however, the company would need to make a few amendments to its clinical trials in order to have the partial hold removed.

Hepatitis B is a contagious disease, and is transmitted via infected blood. Around two billion people around the world are infected by this disease. Symptoms include jaundice, debility, and fever. Around 90% of infected adults recover by developing antibodies against the disease. However, children are mostly unable to develop antibodies, which develops further complications. Currently, vaccinations are used for prevention against the disease.

Arrowhead Research Corp. is a biopharmaceutical firm involved in the development of targeted RNA interference (RNAi) drugs. RNAi is a biological process that targets those genes in the human body which cause Hepatitis B. ARC-520 is expected to be Arrowhead’s first product in the market for the treatment of this contagious disease. It is under investigation for achieving a functional cure, which is defined as an "immune clearant state characterised by hepatitis B s-antigen negative serum with or without sero-conversion," in patients chronically infected with hepatitis B virus.

The company disclosed results for Phase IIa trials in October. The efficacy profile demonstrated that the drug did not live up to the expectations of investors.

The company initially suggested that patients be given multiple doses during Phase IIb trials, with a recommended dosage of two milligrams of the medication for every four kilograms of the drug. However, the FDA insisted that Arrowhead restart the trials with one milligram of medication for one kilogram of the drug.

Furthermore, the FDA also demanded that the results of the Phase IIa trial, in which patients were administered between 1-4 milligrams of the drug per kilogram, be shared. Arrowhead responded by commenting that the study is still undergoing in accordance with the initial plan, and there have been no issues of toxicity among the participating patients.

The drug makes use of a nano-polymer which has been designed specifically to treat the RNA. This new treatment enables the RNA to block the protein, which prevents the immune system’s identification of the hepatitis B virus. However, a dose of one milligram per kilogram reduces the build-up of the protein by only 9%. Arrowhead decided to test up to four milligram per kilogram to find out whether a better response was achievable or not.

CEO of Arrowhead, Christopher Anzalone added that the company would prepare for the Phase IIb trials next month, particularly stressing that Arrowhead would collaborate with the FDA throughout the trials. He also expressed the firm’s plan to register with Asian and European regulators to gain approval for initiating Phase IIb trials.

Gilead Sciences Inc. (NASDAQ:GILD) was interested in acquiring Arrowhead recently to expand its reach to other diseases apart from Hepatitis C. Since Arrowhead already had a drug for Hepatitis B in its pipeline, this move seemed fairly reasonable. The company might still be acquired by Gilead Sciences, and this speculation has led its shares to gain 66% in the last 30 trading days.

newchinabok

FDA暂停测试箭头的（ARWR）乙肝药物
在上周一宣布的交易时段箭头股重挫22％认为FDA已暂时限制进一步的临床试验对公司的乙肝治疗药物
ARWR

由汉娜以实玛利
发布时间：2015年1月13日，在下午4时44 EST


箭头研究公司（NASDAQ：ARWR）的股票罐22％时就宣布周一盘中，美国食品和药物管理局（FDA）已限制进一步的临床试验对公司的乙肝药物的ARC-520，并宣布了部分持有。美国食品药物管理局在箭头被允许开始上药IIb期试验的初步通报称，然而，该公司将需要作出一些修订，其临床试验，以便有部分保持删除。

乙肝是一种传染性疾病，通过受感染的血液传播。世界各地的大约两十亿人感染这种疾病。症状包括黄疸，乏力，发热。大约90％的成年人感染中恢复通过开发抗体对抗疾病。然而，孩子们大多无法产生抗体，从而进一步发展并发症。目前，接种疫苗可用于预防以预防感染。

箭头研究公司是参与有针对性的RNA干扰（RNAi）技术药物发展的生物制药公司。 RNAi是一种生物过程，针对在人体内的那些基因引起乙型肝炎ARC-520，预计将在市场中箭头的第一个产品本传染性疾病的治疗。它是在调查用于实现一个功能的治疗，其被定义为一个“免疫clearant状态特征由乙肝表面抗原阴性血清有或没有血清转化”，在慢性感染乙型肝炎病毒的患者。

公司披露业绩十月IIa期临床试验。功效曲线表明，该药物没有辜负投资者的期望。

该公司最初提出，患者在IIb期临床试验给予多剂量，用两毫克的药物的推荐剂量为每四公斤毒品。然而，FDA的坚持，慈姑重启试验用药物的1毫克的药物一公斤。

此外，FDA还要求该阶段IIa试验中，其中患者被1-4毫克每千克的药物之间施用的结果，进行共享。箭头回应评论，这项研究仍处于按照最初的计划，并且已经出现毒性没有问题中参与病人。

该药物是利用一个纳米聚合物已专门设计来对待的RNA。这种新的治疗方法可以使核糖核酸阻止的蛋白质，这防止了乙肝病毒的免疫系统的识别。然而，每公斤1毫克的剂量减少了积聚的蛋白质通过只有9％。箭头决定测试高达每公斤4毫克，找出一个更好的反应是否实现与否。

箭头首席执行官克里斯托弗Anzalone补充说，该公司将在IIb期临床试验做准备下个月，特别强调箭头将与FDA在整个试验协作。他还表示，该公司计划与亚洲和欧洲的监管机构注册，以获得批准启动IIb期临床试验。

吉利德科学公司（纳斯达克股票代码：GILD）是有意收购箭头近日从丙型肝炎扩大其触角伸向其他疾病除了由于箭头已经有了一个药物乙肝在其管道，这一举动似乎是很合理的。该公司可能仍然由吉利德科学公司收购，而这种猜测导致其股票获得66％，在过去30个交易日

hao2014

Tekmira报道，40“健康”成人参与研究，其中涵盖了两种配方，他们正在测试在临床试验中。四名病人将在每个“队列”，并且他们三人将获得该公司的乙肝治疗而第四将接受安慰剂。

我觉得这句话值得重视
也就是6个病人能够得到药物治疗（箭头的2A好像也就是16个病人而已）

某种意义上，这种方式相当于一期和二期A联合进行了，能够加快进度
我觉得今年年底之前应该 能有疗效的消息了

不知道各位觉得如何
希望这公司能在箭头的基础上更进一步！！！

newchinabok

关键是传递系统，如传递系统不高效，剂量大了有毒性，剂量小了又没效果

战天斗hbv

是说剪头危险了是吗

希望，健康

希望箭头能找到好的办法，我们拭目以待。