EASL2015:REP 2139发现，以减少乙肝表面抗原在白种人与HBV / HDV合

齐欢畅2

关注。

StephenW

回复 战天斗hbv 的帖子

"serum free" - free of serum.这里我不知道它的意思.

StephenW

在这里完整演示:
http://replicor.com/wp-content/u ... -2015-LO2-FINAL.pdf

HBVCURER

关于这个talk有个花絮，Fabian Zoulium（大家都知道是谁吧）在报告后问了一个问题，我当时坐在他不远处，等报告人回答完之后，Zoulium轻轻摇摇头慢慢走回来了

StephenW

回复 HBVCURER 的帖子

我的印象是，REP-2139ca在EASL吸引了大量的关注.
所有的研究与欧洲/美国科学家合作.

HBVCURER

StephenW 发表于 2015-4-27 06:16
回复 HBVCURER 的帖子

我的印象是，REP-2139ca在EASL吸引了大量的关注.

Honestly, it is not, at least not yet. Otherwise it wouldn't cost them almost 6 years to finish the Phase I trial in some places where nobody really knows. However, things might be changed since they need money to continue their clinical studies and therefore, they have to be more transparent and collaborative to the established labs for further evaluation. That might be the reason why you have that feeling. But still it's far from satisfactory if you take the industrial standard.

The biggest problem for them now is that so far their data is not really convincing to the scientific community and what they were doing during the last years was not really focusing on the key question they should be able to answer long time ago. I have to say it' really weird that the biotech company can be run like this. But anyway, I do hope they will get things they promised done finally.

StephenW

回复 HBVCURER 的帖子

I can't disagree more. Replicor had 4 posters and 2 oral presentations at EASL in Vienna. The late breaker presentation on HBV/HDV was selected as special by EASL, and was well attended, even Zouliem was there, as you attested. Now, if you look at the posters and presentations, they were all jointly authored by scientists from Europe and America. As for the HDV clinical trial, sure it was in a small country, but nevertheless, it was an EU country.
If you go to Replicor's website, you will find that they are well funded by two institutions, so I don't think they are short of money.
Replicor is a private biotechnology company, so unlike its publicly listed counterparts, they rely more on results than hype. It is to their credit, that they manage to achieve so much on such meagre resources. Without the human clinical trial results from Replicor, I doubt whether ARC520 will proceed. Interestingly, Dirk, the famous RNAi specialist and blogger, reckoned Replicor had discovered the cure for HDV and he also suggested Arrowhead and Tekmira to find another disease to tackle, given the much greater knock down in HBsAg achieved by REP2139, aka REP9AC. I don't always agree with Dirk, but he is not always wrong. Finally, I disagree with you that most scientists do not believe in their results, after all, it is now almost universally accepted by the top researchers that reduction of viral antigens, such as HBsAg, is essential for restoration of full HBV specific immune functions and is part and parcel of any future curative therapy.

StephenW

Replicor Announces Four Appointments to Scientific Advisory Board

Doug Kornbrust, Ph.D., D.A.B.T.; Jennifer Lockridge, Ph.D.; Michael Roggendorf, M.D.; and Christian Trepo, M.D., Ph.D. to advise Replicor on ongoing clinical development and research
April 27, 2015 06:00 AM Eastern Daylight Time

NEW YORK--(BUSINESS WIRE)--Replicor Inc., a privately held biopharmaceutical company targeting a cure for Chronic Hepatitis B and D patients, today announced the appointments of four clinical experts to its new Scientific Advisory Board. The company has now completed its first series of proof of concept trials and continues to move toward next stage clinical development.

    “The addition of these expert individuals to our Advisory Board will help us gain further perspective into our data as we move into additional clinical trials in 2015 and beyond.”

“We are pleased to mark our move to the next stage of research with these important Scientific Advisory Board appointments,” said Andrew Vaillant, Ph.D., and Chief Science Officer. “The addition of these expert individuals to our Advisory Board will help us gain further perspective into our data as we move into additional clinical trials in 2015 and beyond.”

Doug Kornbrust, Ph.D., D.A.B.T., has extensive experience in the planning and management of nonclinical portions of drug development programs, interactions with regulatory agencies and assistance with regulatory filings and he has held consultancy relationships with more than 170 pharmaceutical companies since 2002. Dr. Kornbrust was formerly Vice President and Scientific Director for Sierra Biomedical (now Charles River Laboratories Nevada) and Director of Toxicology, Pharmacokinetics and Metabolism at ISIS Pharmaceuticals, a leader in the development of oligonucleotide-based medicines.

Jennifer Lockridge, Ph.D. has more than fifteen years of consultancy experience in the oligonucleotide industry and specializes in the pharmacologic and pharmacokinetic evaluation of oligonucleotides. Dr. Lockridge has been involved in numerous pre-IND programs with oligonucleotide-based medicines and has successfully completed several United States FDA regulatory filings for the initiation of clinical studies. Dr. Lockridge was formerly Director of Project Management at Sirna Therapeutics where she was involved with all aspects of siRNA development programs at the pre- and post-IND stages.

Michael Roggendorf, M.D. is currently is a visiting Professor at the Institute for Virology, Technical University of Munich and serves on the Advisory Boards for the German Network of Competence for Hepatitis (Hep-Net) and the SFB / German – Chinese Transregio (SFB/TRR60) and was previously Director of the Institute of Virology, University of Duisburg – Essen and Head of the Diagnostic Laboratory of Viral Diseases and Hepatitis Research at the University of Munich. Dr. Roggendorf has authored more than 370 publications in the areas of virology and viral hepatitis. Recently he published several studies on immunomodulatory therapies in chronic hepatitis B. He is an expert reviewer for national and international research agencies, including the National Institutes of Health (USA).

Christian Trepo, M.D., Ph.D. is currently an Emeritus Professor at Claude Bernard University and a consultant at the Hepatogastroenterology department at Croix Rousse Hospital and acting Director of the Hepatitis Unit (INSERM 1052/CRCL), in Lyon, France. He has previously served in several important positions, including the Advisory Board for the European Association for the Study of the Liver (EASL), President of the French Association for the Study of the Liver, and Medical Coordinator of the Hepatitis C reference Center. Dr. Trepo graduated from the School of Medicine and Sciences of Lyon and Grenoble while completing Fogarty International Center fellowships in Virology at the New York Blood Center and in Hepatology at Cornell University Medical College. He has authored more than 750 articles in the areas of virology and viral hepatitis including hepatitis delta virus (HDV) from its initial finding, where he co-authored the milestone HDV discovery paper.

StephenW

Replicor发布四款委任科学顾问委员会

道格Kornbrust，博士，D.A.B.T;珍妮弗·洛克里奇，博士;迈克尔Roggendorf先生，医学博士;和基督教TREPO，医学博士，博士奉劝Replicor正在进行临床开发和研究
2015年4月27日06:00东部夏令时间

纽约 - （美国商业资讯） - Replicor公司，靶向治疗慢性乙型肝炎和D患者一家私人持有的生物制药公司，今天宣布的4项临床专家到新的科学顾问委员会的任命。公司现已完成了第一个系列概念试验的证明，并继续走向下一个阶段的临床开发。

    “添加这些专家个人我们的顾问委员会将帮助我们获得更多的角度为我们的数据作为我们进入更多的临床试验在2015年及以后。”

“我们很高兴，以纪念我们的举措与这些重要的科学顾问委员会的任命研究下一阶段，”安德鲁威能，博士和首席科学官说。 “添加这些专家个人我们的顾问委员会将帮助我们获得更多的角度为我们的数据作为我们进入更多的临床试验在2015年及以后。”

道格Kornbrust，博士，DABT，已在规划和药物开发计划，监管机构和监管机构备案援助和自2002年以来，他曾担任顾问关系，与170多家制药企业的互动部分的非临床管理方面拥有丰富的经验。 Kornbrust博士曾担任副总裁兼科学主任塞拉利昂生物（现查尔斯河实验室内华达州）和毒理学，药代动力学和代谢总监ISIS制药公司，在基于寡核苷酸药物开发领域的领先。

珍妮弗·洛克里奇博士拥有超过15年的寡核苷酸行业咨询经验，擅长寡核苷酸的药理学和药代动力学评价。洛克里奇博士参与了许多预IND程序寡核苷酸为基础的药物，并已成功地完成了几个美国FDA监管文件用于临床研究的开始。洛克里奇博士曾担任项目管理总监siRNA治疗，她曾参与的siRNA的发展方案的前置和后置IND阶段的各个方面。

迈克尔Roggendorf先生，博士，目前是一个客座教授在德国慕尼黑技术大学的研究所病毒学，并担任了顾问委员会对竞争力的肝炎德国网络（喉癌网）和SFB /德国 - 中国Transregio（SFB / TRR60）和以前病毒学杜伊斯堡大学研究所主任 - 埃森和主管病毒病的诊断实验室和肝炎研究在慕尼黑大学。 Roggendorf先生博士撰写了370多个出版物在病毒学和病毒性肝炎等领域。最近，他发表了几篇研究对慢性乙型肝炎免疫调节治疗，他是一个专家评审为国家和国际研究机构，包括美国国立卫生研究院（美国）。

基督教TREPO，医学博士，博士目前是名誉教授克劳德·贝尔纳大学的顾问在Hepatogastroenterology部门十字鲁塞医院和肝炎股（INSERM 1052 / CRCL）的代理主任，在法国里昂。他曾在多个重要岗位担任，其中包括咨询委员会的欧洲协会为肝脏研究（EASL），法国协会肝脏研究主席，以及丙型肝炎的参考中心的医疗统筹。 TREPO博士医学和里昂和格勒诺布尔科学学院毕业，同时完成Fogarty国际中心奖学金病毒学在纽约血液中心和肝病在康奈尔大学医学院。他撰写了750多篇病毒学和病毒性肝炎，包括从最初的调查结果，在那里他丁型肝炎病毒（HDV）的区域合着的里程碑，HDV发现纸。

HBVCURER

StephenW 发表于 2015-4-28 04:56
回复 HBVCURER 的帖子

I can't disagree more. Replicor had 4 posters and 2 oral presentations at EASL ...

您可能把这里的很多问题都搞混淆了，比如最后一段。抑制HBsAg是未来治愈乙肝的最重要途径之一，我完全同意，但是Replicor是否提供了充分的证据展现了这种能力，以及这些数据的可靠性则是另一回事。至于Replicor和科学界的合作以及经费问题，我之前说的很清楚了，因和果别倒置了。

Replicor的传说在业界流传已有多年了。一开始他们从来不参加任何正式会议，后来逐步参加一些小范围的非主流会议，到现在开始在EASL/AASLD这样的大场面，这应该说是一种进步。但是通过多次和他们的直接接触，我对他们的某些行为和操作方式并不特别接受。而且这种感觉在我认识的同行中并不少见。单从学术上说，Replicor报告中存在很多问题，这也是为什么大家非常关注的原因。比如这次的多个报告和展板中，没有一个提到患者体内DNA的定量结果，回答提问时也刻意回避了这个讨论。而实际上这些数据对于Replicor的置信度和前景有着重要的影响。事实上，前面有朋友说Replicor做研究“东一榔头西一棒子”，恰恰就是我想说的。

我无意和您就Replicor的前景做任何争论。Replicor有很多fans，说实话我也曾经是一员。而如果他们最终取得成功，我们也会感到很高兴，因为这个公司一点也不贵 只不过在此之前，他们需要解决的问题，远比一般人想象的要多。See the wood for the trees，that‘s it.