Replicor宣布发布检查REP 2139抗病毒机制的新研究

StephenW

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我要求提供证据, 请展示.

平凡之路123

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这个药物，一直进入不了3期，这就是最好的证据。

药物问世10年了，突然想起研究药物的作用机制来了，当初是在梦游的状态研发药物的吗？

2139反常的地方太多了，逻辑上说不通，根本圆不了。

平凡之路123

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那你也展示一下REP没造假的证据啊，你能展示吗。

说白了，大家都没证据，你乐意无条件相信它是真实的，但是最起码我有符合逻辑的推理，证明它不是真实的。

你能回答我提出的疑问吗？

StephenW

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Replicor 2017-2018会议报告。 自己读.

Replicor 2017-2018 huìyì bàogào. Zìjǐ dú
Replicor personnel and collaborators attend and often present at all the major international scientific conferences where HBV or HDV is discussed. Selected presentations can be downloaded below.
Date         Conference         Location         Topic          Abstract/Poster
10.11.2018         Hepatitis Delta International Network Meeting
(AASLD 2018)         San Francisco, USA         REP 301-LTF update
REP 2139-Mg transition to SC         HDIN AASLD 2018
9.11.2018         AASLD 2018         San Francisco, USA         Achieving functional cure with REP 2139         REP 401 AASLD 2018
7.11.2018         HBV Cure Workshop 2018         Toronto, Canada         REP 401 study interim follow-up update         HBV Cure Workshop 2018
6.10.2018         2018 HBV International Meeting         Taormina, Italy         Achieving functional cure with REP 2139         REP 2139 clinical HBV INT 2018
5.10.2018         2018 HBV International Meeting         Taormina, Italy         REP 2139 mechanism of action in vitro         REP 2139 vs HBsAg HBV INT 2018
4.10.2018         2018 HBV International Meeting         Taormina, Italy         Apolipoproteins in HBsAg secretion in vitro         Apos vs HBsAg HBV INT 2018
25.09.2018         Discovery on Target 2018: Targeting HBV         Boston, USA         Achieving functional cure with REP 2139         CHT Targeting HBV 2018
15.06.2018        

Global Hepatitis Summit 2018

(16th International Symposium of Viral Hepatitis and Liver Disease)
         Toronto, Canada          Updated follow-up analysis in the REP 401 protocol.          GHS 2018 presentation
09.06.2018        

Science of HBV Cure

(Singapore Hepatitis Conference)
        Singapore, Singapore         Achieving functional control of HBV and HDV infection with REP 2139-based combination therapy         Combination therapy presentation
08.06.2018        

Science of HBV Cure

(Singapore Hepatitis Conference)
        Singapore, Singapore         REP 2139 mechanistic insights and effects in monotherapy         Monotherapy presentation
13.04.2018         EASL ILC 2018         Paris, France         Modelling viral kinetics during REP 2139-Ca monotherapy         Poster FRI-324
13.04.2018         EASL ILC 2018         Paris, France         Updated follow-up data in the REP 301-LTF study (HBV/HDV).         Poster FRI-326
13.04.2018         EASL ILC 2018         Paris, France         Updated follow-ip data in the REP 401 study (HBV)         Poster FRI-343
07.12.2017         HEPDART 2017         Kona, HI, U.S.A.         REP 401 Interim follow-up update         Presentation O-19
21.10.2017         AASLD 2017         Washington, DC, U.S.A         REP 401 Interim follow-up update         Poster LB-24
21.10.2017         AASLD 2017         Washington, DC, U.S.A         Update on NAP mechanism of action in HBV         Poster 957
21.10.2017          AASLD 2017          Washington, DC, U.S.A          Update on NAP mechanism of action in HDV          Poster 942
25.09.2017         CHT Discovery on Target:Targeting HBV         Boston, U.S.A.         Targeting HBsAg secretion with NAPs: Drug development update         Presentation
05.09.2017         HBV International Meeting 2017         Washington DC, U.S.A.         Modelling post-entry effects of NAPs against HBV infection in vitro.         Poster P-146
05.09.2017         HBV International Meeting 2017         Washington DC, U.S.A.         Activity of NAPs against HDV in vivo         Poster P-144
05.09.2017         HBV International Meeting 2017         Washington DC, U.S.A.         NAPs interact with small and large hepatitis delta antigen         Poster P-145
05.09.2017         HBV International Meeting 2017         Washington DC, U.S.A.         HBsAg Quasispecies evolution in the REP 102 trial.         Poster P-127
05.09.2017         HBV International Meeting 2017         Washington DC, U.S.A.         Mathematical modelling of viral dynamics in the REP 102 protocol.         Poster P-148
05.09.2017         HBV International Meeting 2017         Washington DC, U.S.A.         Clinical NAP Summary (critical role for HBsAg suppression in achieving functional cure.         Poster P-147
07.09.2017         HBV International Meeting 2017 Satellite Symposium         Washington DC, U.S.A.         Clinical NAP Summary (critical role for HBsAg suppression in achieving functional cure.         Presentation O-198.
20.04.2017         HDIN meeting (EASL 2017)         Amsterdam, The Netherlands         REP 301 / 301-LTF update HDIN (EASL 2017)         Presentation  HDIN (EASL 2017)
20.04.2017         EASL 2017         Amsterdam, The Netherlands         REP 301 / 301-LTF update LBP-507         Poster LBP-507
20.04.2017         EASL 2017         Amsterdam, The Netherlands         REP 401 update EASL 2017 THU-154         Poster THU-154
20.04.2017         EASL 2017         Amsterdam, The Netherlands         REP 102 HBsAg deep sequencing EASL 2017 THU-155         Poster THU-155
20.04.2017         EASL 2017         Amsterdam, The Netherlands         NAP post-entry activity modelling in vitro EASL 2017 THU-156         Poster THU-156
20.04.2017         EASL 2017         Amsterdam, The Netherlands         Modeling HBsAg and HDV DNA kinetics EASL 2017 THU-173         Poster THU-173
18.02.2017         APASL 2017         Shanghai, China         Update on Safety and Efficacy in the REP 401 protocol         APASL 2017 oral presentation

StephenW

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Peer Reviewed同行评审 Publications on Replicor's NAP Technology: 2018-2017

Inhibition of HBsAg secretion by nucleic acid polymers in HepG2.2.15 cells.

Blanchet M, Sinnathamby V, Vaillant A, Labonté P. Antiviral Research 2019 epub Feb 13, 2019.

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Variants of hepatitis B virus surface antigen observed during therapy with nucleic acid polymer REP 2139-Ca have no influence on treatment outcome and its detection by diagnostic assays.

Mijočević H, Karimzadeh H, Seebach J, Usman Z, Mamun AM, Bazinet M, Vaillant A, Roggendorf M. Journal of Viral Hepatitis 2018 epub Nov 19, 2018.

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REP 2139: Antiviral Mechanisms and Applications in Achieving Functional Control of HBV and HDV Infection.

Vaillant A. ACS Infectious Diseases 2018 epub Oct 8, 2018.

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Nucleic acid polymer REP 2139 and nucleos(t)ide analogues act synergistically against chronic hepadnaviral infection in vivo.

Quinet J, Jamard C, Burtin M, Lemasson M, Guerret S, Sureau C, Vaillant A, Cova L. Hepatology 2017 epub Dec 18 2017.

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Nucleic acid polymers are active against Hepatitis Delta Virus infection in vitro.

Beilstein F, Blanchet M, Vaillant A, Sureau C. Journal of Virology 2017 epub Dec 6 2017.

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Activity of nucleic acid polymers in rodent models of HBV infection.

Schöneweis K, Motter N, Roppert PL, Lu M, Wang B, Roehl I, Glebe D, Yang D, Morrey JD, Roggendorf M, Vaillant A. Antiviral Research 2017 epub Nov 8, 2017.

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Safety and efficacy of REP 2139 and pegylated interferon alfa-2a for treatment-naive patients with chronic hepatitis B virus and hepatitis D virus co-infection (REP 301 and REP 301-LTF): a non-randomised, open-label, phase 2 trial

Bazinet M, Pântea V, Cebotarescu V, Cojuhari L, Jimbei P, Albrecht J, Schmid P, Le Gal F, Gordien E, Krawczyk A, Mijočević H, Karimzadeh H, Roggendorf M, Vaillant A. The Lancet Gastroenterology & Hepatology 2017 epub Sept 27, 2017.

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REP 301 study protocol

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Inhibition of hepatitis B viral entry by nucleic acid polymers in HepaRG cells and primary human hepatocytes

Guillot C, Martel N, Berby F, Bordes I, Hantz O, Blanchet M, Sureau C, Vaillant A, Chemin I. PLOS ONE 2017 12: e0179697.

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Nucleic Acid Polymers with Accelerated Plasma and Tissue Clearance for Chronic Hepatitis B Therapy.

Roehl I, Seiffert S, Brikh C, Quinet Q, Jamard C, Dorfler N, Lockridge JA, Cova L, Andrew Vaillant A. Mol Ther Nuc Acids. 2017 8: 1-12.

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Nucleic acid-based polymers effective against hepatitis B Virus infection in patients don’t harbor immunostimulatory properties in primary isolated liver cells.

Real CI, Werner M, Paul A, Gerken G, Schlaak JF, Vaillant A, Broering B, Sci. Reports. 2017 7: 43838.

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平凡之路123

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这公司热衷于参加各种肝病国际大会，然后把自己的实验数据或者报告，跟大会的其他文献集结出版。

这可以说明，2139的药物是有真实疗效的？

我希望我的质疑都是错的，我希望它是真实的，我希望它明天就上市。

newchinabok

StephenW 发表于 2019-2-26 20:26
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到三期再讨论也不晚。

平凡之路123

此次公布的是REP 401试验（NCT02565719）最新的随访数据，该项研究评估了 REP 2139-Mg 或 REP 2165-Mg，聚乙二醇干扰素α-2a（pegIFN）和富马酸替诺福韦酯（TDF）联合治疗48周的安全性和有效性（TDF）。

在完成24周无治疗随访的患者中，功能性抑制(HBV DNA < 1000 IU/mL)的患者比例达到87％（其中79％ HBsAg <10 IU / mL），功能性清除 (HBV DNA < LLOQ)的患者比例为 70％（其中66％未检测到 HBsAg [0.00 IU / mL]）。92％的患者肝功能正常。

公司 CSO Andrew Vaillant 博士对此评论到：“REP 2139 在 90％ 的患者中迅速降低 HBsAg 的能力在该行业中是独一无二的，伴随着血液中病毒血症的立即减少和肝脏中病毒复制抑制。在临床前研究中，单独这一效应便已导致完全控制肝脏中的cccDNA并大幅度减少cccDNA。”

平凡之路123

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我也希望它能进入三期啊，可它偏偏不进，气死人。

newchinabok

平凡之路123 发表于 2019-2-26 20:43
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我也希望它能进入三期啊，可它偏偏不进，气死人。

美国临床试验网显示再没有新开临床试验项目了。说明三期rep很难开展的