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肝胆相照论坛 论坛 学术讨论& HBV English [新闻稿]Hepatera招收第一阶段1b/2a临床的MyrcludexHBV ...
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[新闻稿]Hepatera招收第一阶段1b/2a临床的MyrcludexHBV患 [复制链接]

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发表于 2012-12-13 13:57 |只看该作者 |倒序浏览 |打印

http://www.cnbc.com/id/100306017
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麦克斯韦生物技术风险投资基金的投资组合公司Hepatera招收第一阶段1b/2a临床审判的Myrcludex乙为HBV患者
Maxwell Biotech Venture Fund’s Portfolio Company Hepatera Recruits First Patients in Phase 1b/2a Clinical Trial of Myrcludex B for HBV

Published: Wednesday, 12 Dec 2012 | 11:14 AM ET
   
   

MOSCOW--(BUSINESS WIRE)-- Hepatera, a Russian biotech company and part of Maxwell Biotech Venture Fund’s portfolio, has announced today the inclusion of the first three patients with chronic hepatitis B in the clinical trial phase Ib-IIa of Myrcludex B. Hepatera was founded in 2011 and is focused on the development of innovative therapeutics for the treatment of liver diseases. The study is being conducted in major Russian specialized clinical centers and its results are expected in the end of 2013.

Hepatera is a resident of the Skolkovo Biomedical Cluster and has been financed by Maxwell Biotech Venture Fund. Myrcludex B, an innovative drug candidate for the treatment of chronic viral hepatitis B and D, is developed in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds.

Despite the widespread introduction of vaccination, chronic hepatitis B remains an unsolved health problem. According to the WHO close to 2 billion people in the world are carriers of HBV, of which about 400 million are chronically ill. Every year approximately 50 million people get infected with HBV and almost 2 million people die from liver conditions caused by this infection. Co-infection with HDV which is diagnosed in about 5% of cases increases the severity of the disease doubling the frequency of complications and mortality rate, compared to monoinfection. To date there are limited options to treat the HDV co-infection.

"It is very important for us that we take part in such a large international project and have the opportunity to be the first center to evaluate the effectiveness of the Myrcludex in patients. We hope that the positive results of this clinical trial will allow the company to continue the development of the drug, which offers a new approach to the treatment of patients with hepatitis B, and will be able to significantly improve and simplify the existing treatment regimen," said Elena Volchkova, consultant for "Infectious Clinical Hospital № 2" of the Moscow Department of Health, Doctor of Medical Science, Head of the Department of Infectious Diseases of the Sechenov First Moscow State University, principal investigator.

"We are excited to see that Myrcludex has now moved into the clinical study in patients who might benefit from the treatment. In this study we have a particular emphasis on safety, but also looking at HBsAg levels which remain unaffected by current standard treatment regimens in the majority of patients. With the HBV receptor identified now, we hope that the results will boost the field and deliver a milestone in combating this important disease,” said Alexander Alexandrov, Chief Scientific Officer at MYR GmbH.

About Myrcludex B

The idea for Myrcludex B was developed within two renowned research institutions in Europe, the French National Institute of Health and Medical Research (INSERM) and University of Heidelberg in Germany. Myrcludex inhibits the essential HBV receptor on the liver cell surface and thus prevents the infection of the healthy cells and viral spreading in the liver. Entry inhibitors are well established in the treatment of viral infections (Celsentri®, Relenza®). During the chronic HBV infection new liver cells constantly become infected. By the treatment with an entry inhibitor, this new infection may be inhibited and the number of the infected cells should significantly decline within a few months. The immune system could then regain the control over the infection and the long-term treatment with viral replication inhibitors could be omitted or significantly shortened. HDV is using the HBV receptor to get into the cell. As expected, Myrcludex has shown great efficacy against HDV in preclinical tests. Clinical trial Phase Ia conducted by MYR in Germany in healthy volunteers showed good safety and tolerability.

About MYR

MYR GmbH, a biotechnology company located in Burgwedel near Hannover was founded in 2010 and holds world-wide exclusive product rights for Myrcludex. The company has successfully conducted preclinical development and a Phase 1 clinical trial of Myrcludex. Currently, MYR is focused on the coordination of the network of academic partners and vendors involved in Myrcludex development and is collaborating with Hepatera Ltd in the proof of concept clinical trial.

About Hepatera

Hepatera, Ltd is a private biotechnology company, founded in 2011 with the mission to develop and launch into the Russian market innovative products for the treatment of liver diseases. Hepatera has been a resident of Skolkovo Biomedical Cluster since December 2011. The first product (Myrcludex B) is aimed at treatment of chronic viral hepatitis B and D, and is developed in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Gründerfonds (HTGF), one of Europe’s largest venture funds.

About Maxwell Biotech Venture Fund

Maxwell Biotech Venture Fund (MBVF) is one of the first Russian funds dedicated to investments in the life science sector and has been formed with the participation of Russian Venture Company (RVC). MBVF relies on an experienced international team of managers and financial and industry experts and has offices in Moscow and Boston. MBVF is investing in product development companies specializing in specific therapeutic areas or medical devices categories. To date, MBVF has invested in OncoMax (oncology), NeuroMax (CNS), MetaMax (oncology & metabolic diseases), Infectex (infectious diseases), CardioNova (cardiovascular diseases), Hepatera (liver diseases), Osteros Biomedica (cancer-induced bone diseases), Eleventa (inflammatory respiratory diseases) and Photonics (novel lasers for medicine and dentistry). Products in these companies originated either from Russian scientists or were licensed from international biopharma companies.

About RVC

RVC is a government fund of funds and a development institute of the Russian Federation; since 2006 it has been one of Russia’s key tools in building its own national innovation economy. RVC invests government capital through VC funds that it creates in partnership with private investors.

RVC has backed 12 funds (including two funds outside Russia) with a total capitalization of RUB 26 billion (about US$860 million), its share amounting to RUB 16 billion (about US$530 million). As of November 2012, RVC-backed funds hold a portfolio of 126 companies, with invested capital totaling RUB 10.8 billion (about US$350 million).

RVC-USA
Jeff Gulko, 857-284-7220, ext. 154
Public Relations Manager
[email protected]

Source: RVC

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才高八斗

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发表于 2012-12-13 13:57 |只看该作者
新闻稿
麦克斯韦生物技术风险投资基金的投资组合公司Hepatera招收第一阶段1b/2a临床审判的Myrcludex乙为HBV患者

发布时间:周三,12 2012 | 11:14 AM ET



莫斯科 - (BUSINESS WIRE) -  Hepatera,俄罗斯的生物技术公司的麦克斯韦生物技术风险投资基金的投资组合的一部分,今天宣布列入前三慢性乙型肝炎患者在临床试验阶段IB-IIA Myrcludex B. Hepatera成立于2011年,专注于开发创新疗法治疗肝病的。俄罗斯主要的专业临床中心的研究正在开展,其结果预计将在2013年年底。

Hepatera是其居民的斯科尔科沃生物医学联网,并已麦克斯韦生物技术风险投资基金提供资金。 Myrcludex乙,一个创新药物的候选治疗的慢性病毒肝炎乙和ð,是开发与一家德国生物技术公司MYR有限公司,一个投资组合公司的高新技术Gründerfonds(HTGF),欧洲最大的风险投资基金之一的密切合作。

尽管慢性B型肝炎疫苗接种的广泛引进,仍然是一个悬而未决的健康问题。据接近2亿人在世界上的人是乙肝病毒携带者,其中约400万为长期病患者。每年约50亿人感染乙肝病毒和近200万的人死于这种感染引起的肝脏疾病。合作与HDV感染,这是在约5%的病例诊断增加并发症和死亡率的频率加倍,相比单一慢性感染者的疾病的严重程度。至目前为止是有限的治疗HDV合并感染。

“这是对我们非常重要,我们参加这样一个大型的国际项目,并有机会成为第一个中心的患者的Myrcludex在的有效性进行评估。我们希望这项临床试验取得的积极成果,将允许该公司继续发展的药物,乙肝患者的治疗提供了一种新的方法,将能显着改善和简化现有的治疗方案,说:“埃伦娜Volchkova,顾问,”传染病临床医院№2“在莫斯科卫生署,医学博士,传染病的谢切诺夫第一届莫斯科州立大学,主要研究部主管。

“我们很高兴地看到,现已进入Myrcludex可能从治疗中获益的患者的临床试验中,在这项研究中,我们有一个特别注重安全性,也期待在HBsAg水平由目前的标准治疗方案不受影响广大患者。随着HBV受体识别,亚历山大·亚历山德罗夫说:“现在,我们希望的结果将推动该领域,并提供一个里程碑,在打击这一重要疾病,在MYR有限公司首席科学官。

关于Myrcludex乙

在欧洲,法国国家健康与医学研究所(INSERM)和德国海德堡大学的想法Myrcludex乙两个著名的研究机构内。 myrcludex抑制的基本HBV肝细胞表面的受体上,从而防止感染的健康细胞和病毒在肝脏中蔓延。进入抑制剂成立于治疗病毒感染(Celsentri®,乐感清®)。在慢性乙肝病毒感染新的肝细胞不断受到感染。新的感染到一个条目抑制剂治疗,这可能被抑制,并在几个月内,受感染的细胞的数目应该显着下降。的免疫系统,然后可以恢复控制感染和长期治疗与病毒复制抑制剂可以省略或显着缩短。 HDV被使用的HBV受体进入细胞。正如预期的那样,Myrcludex表现出极大的功效,对HDV的临床前测试。 MYR在德国,在健康志愿者中进行的临床试验阶段的iA具有良好的安全性和耐受性。

关于MYR

MYR有限公司,位于Burgwedel的汉诺威附近的一家生物技术公司,成立于2010年,拥有全球范围内的独家产品为Myrcludex的权利。该公司已成功地进行了临床前开发阶段,第一阶段的临床试验的Myrcludex。目前,马来西亚的重点是学术参与Myrcludex发展的合作伙伴和供应商的网络上的协调和合作,与Hepatera有限公司在新概念的临床试验的证明。

关于Hepatera

Hepatera有限公司是一家私营生物技术公司,成立于2011年的任务,进入俄罗斯市场的开发和推出创新产品,为肝脏疾病的治疗。自2011年12月以来,一直是居民Hepatera的斯科尔科沃生物医学集群。的第一个产品(Myrcludex乙)的目的是在治疗慢性病毒肝炎乙和ð,并正在开发在与一家德国生物技术公司MYR有限公司,一个投资组合公司的高新技术Gründerfonds(HTGF),欧洲最大的合资企业之一的密切合作资金。

关于麦克斯韦生物技术风险投资基金

麦克斯韦生物技术风险投资基金(MBVF)是其中的第一个俄罗斯基金,致力于在生命科学领域的投资,并已经形成了与俄罗斯合资公司(RVC)的参与。 MBVF依赖于经验丰富的国际团队的管理人员,金融和行业专家在莫斯科和波士顿等地设有办事处。 MBVF投资于在特定的治疗领域或医疗器械类产品开发的专业公司。至目前为止,MBVF投资肿瘤科)OncoMax(,NeuroMax(CNS),配戴(肿瘤学和代谢性疾病),Infectex(传染病),CardioNova(心血管疾病),Hepatera(肝脏疾病),Osteros BIOMEDICA(癌症引起的骨疾病),Eleventa(炎症性呼吸系统疾病)和光子学(新型激光医学和牙科)。这些公司的产品源于无论是从俄罗斯科学家或授权的国际生物制药公司。

关于RVC

RVC是一个政府性基金,资金和发展研究所,俄罗斯联邦,自2006年以来,它一直是俄罗斯的主要工具之一,在建设自己的国家创新经济。 RVC政府的资本投资的风险投资基金,它创造了与私人投资者合作。

,RVC已经放弃RUB 26亿美元资本总额的12只基金(其中包括俄罗斯的两只基金外)(约合860亿美元),其份额达16亿美元(约5.3亿美元)擦。截至2012年11月,RVC担保基金持有的126家公司的投资组合,投资资金RUB 10.8亿美元(约3.5亿美元)。

RVC-USA
杰夫·Gulko,857-284-7220,分机。 154
公共关系经理
Jeff.Gulko RVC-usa.com

资料来源:RVC

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发表于 2012-12-13 18:45 |只看该作者
鼓掌。好消息啊 ,进入人体试验了,并且是乙肝携带者实验。期待,关注

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发表于 2012-12-13 18:53 |只看该作者
三名乙肝病毒携带者进入1B至2A阶段的实验。。。。该公司成立于2011年,其主要进行肝脏类疾病药物的创新研究,该研究由俄罗斯临床研究中心主导,此阶段试验结果有望在2013年底揭晓。。。。。。。。。在德国的健康志愿者中进行的临床试验阶段已经证明了其具有良好的安全性和耐受性。。。。

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发表于 2012-12-13 19:28 |只看该作者
真心希望它好

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发表于 2012-12-14 07:31 |只看该作者
非常期待

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发表于 2012-12-14 08:12 |只看该作者
1b/2a阶段,主要测试该药的什么性能?

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发表于 2012-12-14 10:57 |只看该作者
这类应该是注射类药物吧,应该会很快。

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发表于 2012-12-15 01:33 |只看该作者
本帖最后由 MP4 于 2012-12-15 01:38 编辑

HBV包膜源性侵入抑制剂Myrcludex B-hepatera
http://www.hbvhbv.info/forum/forum-viewthread-tid-1209484-fromuid-320872.html
http://www.hepatera.ru/node/37?ln=en

“The open randomized clinical trial of the daily use of Myrcludex B compared with entecavir恩替卡韦 in patients with HBeAg-negative(HBeAg 阴性)chronic hepatitis B, Phase Ib-IIa” approved by the Russian Ministry of Health will be conducted by Hepatera in specialized clinical centers in major Russian cities: Moscow, Saint-Petersburg, Chelyabinsk and Samara.
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