大会闭幕了，跪求REP 9AC最新消息！

硬生生挺起

回复 StephenW 的帖子

看不到希望了

rocgao

正常，基于正常学术研究到临床应用的时间周期算，今天的结果并不意外。我早就预见到了，今年四月份讲相比rep9ac我更看好mycrludex时很多人还不相信。
按照现在国际免疫研究现状、hbv发病机理及标志物研究等相关研究现状来看，再过5-10年能够开发出高效治疗性药物我觉得都已经是很乐观了。
现在，踏踏实实治疗、定期检查我觉得比什么都好。

hzm334552863

谁对47楼的翻译下

cshbv

回复 StephenW 的帖子

Myrcludex B 被相信可以防止细胞间的再感染，也是非常厉害的新药。根据以前的信息，今年8月会开始临床试验。

StephenW

回复 rocgao 的帖子

This may be related to Mycrludex:
OCT is a private CRO (contract reseach organization). The clinical trial has not yet started.  
这可能是有关Mycrludex：
OCT是一个私人的CRO（合同研制组织）。临床试验尚未开始。
32 HBeAg阴性患者，临床超过21个月.

OCT starts a Phase 2a multinational clinical trial in hepatitis B virus infection                              http://out-clinicaltrials.com/?q=content/oct-starts-phase-2a-multinational-clinical-trial-hepatitis-b-virus-infection

                                                                                                                                  3 April 2012


OCT has been awarded a Phase 2a multinational, randomized, open-label clinical trial of daily administration of investigational drug versus standard of treatment in patients with HBeAg negative chronic hepatitis B virus infection. The client is a new Russian biotech company specialized in liver diseases and backed by Russian and foreign venture capital.
The investigational drug candidate could potentially be used for treatment of chronic hepatitis B (CHB) and chronic hepatitis D (CHD). The drug's unique mechanism of action offers the possibility to address the two most important medical needs, namely long-term HBV (hepatitis B virus) eradiation as well as antiviral activity against hepatitis delta virus (HDV). The main goal of the novel treatment approach will be to reduce HBsAg levels in serum of the patients.
The clinical study will be placed in Russia and Ukraine and involve 4 sites enrolling 32 patients within 8 months. The total study duration is estimated as 21 months, including data management and final statistical report.
OCT will provide full-service assistance starting from regulatory documents preparation and support, e-CRF development and data base setup, sites selection and start-up, project managementand clinical monitoring, up to safety management, quality assurance, vendors' management, interim analysis, WRS, final report preparation. Leading European PK, immunology, and virology laboratories will be included into the study to provide biological samples analysis support.
In Russia HBV vaccination was included into the National Immunization Schedule in 2001. Since then all newborn infants are vaccinated thrice. Since 2006 vaccination in adults started in Russia as well. By the present moment around 46 million people have been inoculated against hepatitis B virus, and more than a million are suffering from chronic hepatitis B in the country.
According to the WHO, the total population of chronic hepatitis B patients exceeds 1 billion globally. According to European experts' information, more than 2 billion people are infected by hepatitis B virus worldwide.
In Russia the popularity of hepatitis B antigen carriers is variable: less than 1 % in the European part of the country, 4-5% in the Eastern Siberia, 8-10% in the Northern Caucasus, Yakutia, and Tyva. In highly endemic regions the hepatitis B incidence rate comes up to 120-280 per 100 000. Nowadays the hepatitis B incidence is around 35,8 in Russia. Together with HIV and hepatitis C, hepatitis B is one of the most dangerous viral parenteral infections resulting in human average lifetime decrease globally.


OCT公司 开始阶段2A跨国在B型肝炎病毒感染的临床试验
2012年4月3日

OCT先后被授予相2A多国​​，随机，开放标签临床试验的日常管理，研究药物对HBeAg阴性慢性乙型肝炎病毒感染患者的治疗标准。客户端是一个新的俄罗斯生物技术公司，专门从事肝脏疾病和由俄罗斯和外国的风险资本支持。

研究候选药物可能被用于治疗慢性乙型肝炎（CHB）和慢性丁型肝炎（CHD）的。药物的独特的作用机制提供了可能性，以解决两个最重要的医疗需求，即长期HBV（乙肝病毒）放射以及对丁型肝炎病毒（HDV）的抗病毒活性。主要目标将是新的治疗方法，以减少患者的血清中HBsAg水平。

将被放置在俄罗斯和乌克兰的临床研究，涉及8个月内4点招收32例。估计总的学习时间为21个月，包括数据管理和最终的统计报告。

华侨城将提供全方位服务的援助，从规范性文件的准备和支持，E-CRF的发展和数据的基础上设置，选址和启动，项目管理以及临床监测，安全管理，质量保证，供应商的管理，分析中期开始，应激，最终报告的编写工作。通往欧洲的PK，免疫学，病毒学实验室将被纳入研究，以提供生物样品的分析支持。

在俄罗斯的乙肝疫苗接种纳入国家免疫规划，在2001年。从那时起，所有新生儿接种疫苗三次。自2006年以来接种疫苗的成年人也开始在俄罗斯。由目前的约46万人已接种抗乙型肝炎病毒，超过一百万患有慢性乙型肝炎在该国。

根据世界卫生组织的慢性乙型肝炎患者的总人口超过1亿美元全球。根据欧洲专家的资料，超过2亿人感染乙肝病毒全世界。

    B型肝炎抗原携带者的普及是在俄罗斯变量：小于1％，在欧洲部分国家，在东西伯利亚的4-5％，8-10％，在北高加索地区，雅库特，图瓦。在高流行地区B型肝炎的发病率是每100 000 120-280。如今乙型肝炎的发病率大约是在俄罗斯35,8。连同艾滋病毒和丙型肝炎，B型肝炎是导致全球人类的平均寿命下降的最危险的病毒性肠道感染。

MP4

OCT has applied for regulatory approval of a clinical trial in Hepatitis B
16 May 2012
At the end of April 2012, OCT clinical team prepared documents required for regulatory and ethics submission for a Phase Ib/IIa multinational, randomized, open-label clinical trial of daily administration of the investigational drug versus standard of treatment in  patients with HBeAg negative chronic hepatitis B virus infection.

The following list of documents has been submitted to the Russian Ministry of Healthcare and Social Development by OCT in order to obtain clinical trial approval:  the letter of application; the application form; the power of attorney; the final study protocol; the informed consent form and patient’s information sheet; the insurance agreement for 36 patients; information regarding any compensation for patients; the investigator’s brochure; the list of trial sites; PIs’ CVs and statements of compliance with the study protocol signed by investigators; the document confirming state fee payment; information letter confirming relations between Russian biotech (licensee) and German licenser (developer) and cGMP contract manufacturer.

This study is designed to investigate changes in HBsAg level affected by IND treatment; to assess safety and tolerability, the virological response (HBV DNA level), the biochemical response, PK profile and immunogenicity of the investigational drug.

There will be a 12-week treatment period and a 12-week follow-up period. On receiving the results on viral load and evaluating clinical and biochemical picture of the disease, all the patients will continue their treatment in accordance with the applicable standards.

The study drug has been tested previously in pre-clinical research (mice, rats, dogs, chimpanzee) and a phase I trial in 24 healthy volunteers in the EU. Study drug efficacy in reducing activity of Hepatitis B viral, no cytotoxicity and no lethal outcomes have been demonstrated within early stage research.

The clinical study will be placed in Russia and Ukraine and enroll 32 subjects at 8 sites. Recruitment is to be initiated in August 2012 and ended in December 2012; the clinical trial closure is planned in December 2013. OCT will perform full-service clinical trial support and hope to continue its strategic collaboration with the Sponsor within other clinical research projects.

kaorusai

Myrcludex B和rep9ac效果是一样的吗？

StephenW

回复 kaorusai 的帖子

Myrcludex B - 不能治愈乙肝, 用于与现有的药物.
rep9ac - 可能治愈乙肝.

我个人的意见.

咬牙硬挺

问题是rep最近失踪了没有消息，莫非在论坛潜水？

StephenW

回复 咬牙硬挺 的帖子

将在AASLD2012(11月)上升, Myrcludex和其他。非常令人兴奋的.