2007-2004
HCV Polymerase Inhibitor R7128 Demonstrates
Antiviral Activity in Prior Non-responders
Experimental HCV Polymerase Inhibitor GS 9190
Shows Promising Antiviral Activity but Possible Cardiac Side Effects
in Phase 1 Study
Experimental Polymerase Inhibitor HCV-796 is Safe and
Effective in Combination with PegIntron or Pegasys
Novel HCV Polymerase Inhibitor VCH-759 Monotherapy
Demonstrates Promising Antiviral Activity
-
Polymerase Inhibitor NM107 and Protease Inhibitor
Boceprevir Show Enhanced Anti-HCV Activity in Combination
The Big 3 at AASLD: Drugs in Development
Medivir: Initiation of a Phase IIa Clinical Trial with Investigational
Hepatitis C Protease Inhibitor TMC435350 -
Inhibitex Obtains License To HCV Polymerase Inhibitors
VX950
Protease Inhibitor
Telaprevir
Data On Investigational Compounds Being
Co-Developed By Tibotec For The Treatment Of Chronic Hepatitis C Presented
At EASL 2008
Nov-Oct
Focus on AASLD 2007: Drugs in Development, by Alan
Franciscus.
In vitro activity and preclinical pharmacokinetics of
the HCV protease inhibitor TMC435350
Results of a Phase I Placebo-Controlled Trial in
Healthy Volunteers to Examine the Safety, Tolerability and PK of the HCV
Protease Inhibitor TMC435350 after Single and Repeated Dosing in healthy
volunteers
Tibotec HCV Protease Inhibitor
-
Antiviral activity of the non-nucleoside polymerase
inhibitor, VCH-759, in chronic Hepatitis C patients:Results from a
randomized, double-blind, placebo -controlled, ascending multiple dose study
-
2- New HCV Drugs at AASLD
-
FDA Grants "Fast Track" Development Status to New Oral
Drug R7128 for Treatment of Chronic Hepatitis C
New Virus Drug Will Have To Shoot At Moving Targets
Combination Therapy with HCV Protease Inhibitor
Boceprevir Produces a High Rate of Early Virological Response in Genotype 1
Hepatitis C Patients
-
Discovery of a novel class of Hepatitis C Polymerase Inhibitors
Pharmasset Initiates Phase 1 Dose-ranging Study of
R7128 plus Pegasys plus Copegus in Genotype 1, Treatment-naive Hepatitis C
Patients
The Antiviral Efficacy of the Nonnucleoside HCV Polymerase Inhibitor
A-848837 in the HCV Infected Chimpanzee -
Preclinical Characterization of TMC435350, a novel macrocyclic inhibitor of
the HCV NS3/4A serine protease
Maxygen Announces Hold on Development of MAXY-alpha
(R7025) for Treatment of Hepatitis B and C
Welcome to the
HCV Advocate’s AASLD Conference coverage.
In an effort to best serve our readership, we will post all
the important and interesting abstracts about HCV from the
conference. While attending the conference, we will update
any abstracts that we personally cover at the
conference. The updated abstracts will be marked with the
date that they have been updated and posted.
|
Sept-June 2007
Helicase Target for HCV Therapy
Idera Pharmaceuticals Initiates Phase 1 Trial of IMO-2125 in Hepatitis C
-
Interim Efficacy and Resistance Data from a Phase II
Study of Telaprevir (VX-950) Plus Pegylated Interferon and Ribavirin in
Previously Untreated Patients with Hepatitis C
Nucleoside Analog HCV Polymerase Inhibitors May Have a
Higher Barrier to Resistance than Other Directly Targeted Anti-HCV Agents
New Data on the Experimental Oral HCV Polymerase
Inhibitor R7128 and Related Compounds
InterMune Announces Approval of New Phase 1b Trial of
HCV Protease Inhibitor ITMN-191
Two Recent Articles Focus on the Use of Telaprevir
(VX-950) plus Pegylated Interferon Alfa-2a (Pegasys) in Patients with
Chronic Hepatitis C
XTL Biopharmaceuticals Presents a New Class of Highly Potent Small Molecule
Inhibitors of Hepatitis C Affecting the NS5A Target at an International
Scientific Conference -
HCV-796 Dosing Discontinued
Romark Initiates Phase II Clinical Trial of
Nitazoxanide (Alinia) for Chronic Hepatitis C
-
Triphasic Decline of Hepatitis C Virus RNA during
Interferon-based Antiviral Therapy
Idenix Suspends Testing of HCV Polymerase Inhibitor
Valopicitabine (NM283)
OraSure Technologies Announces Pre-Clinical Study Results for Prototype
Rapid HCV Antibody Test at AACC Annual Meeting
-
Valopicitabine Results
Pharmasset and Roche Initiate Studies to Advance R7128 Polymerase Inhibitor
for HCV -
New RNAi HCV Drug
SciClone begins phase II trial of hepatitis C drug
Valopicitabine (NM283) Produces Greater Suppression of
HCV When Added to Pegylated Interferon plus Ribavirin
Valopicitabine Combined with Standard of Care Cleared
Hepatitis C Virus in 72% of Patients Who Completed 12 Weeks of Treatment in
a Phase II Trial: no ribavirin-Valopicitabine drug interaction -
Development of Drug Resistance in Patients Treated
with HCV Protease Inhibitor Telaprevir (VX-950)
ViroPharma Announces Completion of Enrollment in 500mg
BID Arms of HCV-796 Phase 2 Study
Phase III data looks promising for GSK's eltrombopag
XTL-2125 Hep C Drug Fails
Cytheris to start two phase I/IIa clinical trials of CYT107, its new
recombinant Interleukin-7, in Hepatitis C and oncology
-
12 weeks VX-950 Therapy
-
42nd EASL
April
11 - 15, 2007
Barcelona, Spain
THE EUROPEAN
ASSOCIATION FOR THE STUDY OF THE LIVER
EASL April 2007
EASL 2007
Liz Highleyman
Two Studies Yield Mixed Results for HCV Polymerase
Inhibitor Valopicitabine
R1479 (R1626), a Novel Hepatitis C Polymerase
Inhibitor: Lack of Pre-Existing Resistance Mutations Supports the Observed
In Vivo High Barrier to Resistance
Favorable Cross-Resistance Profile of Two Novel
Hepatitis C Virus Inhibitors, SCH 503034 (Boceprevir) and HCV-796, and
Enhanced Anti-Replicon Activity Mediated by the Combined Use of Both
Compounds
SCH503034 & NM283 Not Cross-Resistant
Resistance Selection to the HCV Nucleoside Polymerase
Inhibitor R1479 (R1626) and to the Protease Inhibitor VX-950
Abbott HCV Polymerase Inhibitor
Vertex Pharmaceuticals Announces New Data for
Investigational HCV Protease Inhibitor Telaprevir to be Presented at 42nd
Annual Meeting of the European Association for the Study of the Liver (EASL)
-
Resistance to New HCV Antivirals
-
NM283, HCV Polymerase Inhibitor in Non-Responders
NM283 in Treatment-Naives Looks Better
New HCV Drug Target NS4A Antagonists
Interim Results Presented at EASL from PROVE 1
Clinical Trial of Investigational Drug Telaprevir in Patients with Genotype
1 Hepatitis C
GSK625433: A Novel and Highly Potent Inhibitor of the
HCV NS5B Polymerase -
Merck HCV Protease & Polymerase Inhibitor Viral Load
Reduction & Resistance in Chimps
GSK625433: A Novel and Highly potent Inhibitor of the
HCV NS5B Polymerase -
HCV-796 Polymerase Inhibitor Shows 1.5 log Viral Load
Reduction
3-Drug HCV therapy for 12 weeks: VX950+pegIFN+RBV,
interim results from phase II PROVE 1 Trial
2007
Despite Promising Early Data, Companies Discontinue
Experimental HCV Protease Inhibitor GS 9132
New HCV Drug R7128 Polymerase Inhibitor
Abbott and Enanta Form Alliance to Develop HCV
Protease Inhibitors
You Are Invited: Clinical Care Options for Hepatitis
Symposium 2007
VX-950 Phase 2b PROVE 1 Study Interim Safety & Antiviral Activity at Week 12
-
New HCV Drug Celgosivir/MX-3253, oral alpha-glucosidase I inhibitor
Vertex Pharmaceuticals Announces Results of First Interim Safety and
Antiviral Analysis of the PROVE 1 Clinical Trial of Investigational HCV
Protease Inhibitor Telaprevir (VX-950) -
Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) in
Combination With Ribavirin in Treatment-Naive Patients With Chronic
Hepatitis C -
Pevion Biotech Announces Its Hepatitis C Therapeutic Vaccine Enters Clinical
Phase I
InterMune Initiates Phase 1a Clinical Trial Evaluating Hepatitis C Protease
Inhibitor ITMN-191 in Collaboration with Roche
- (12/20/06)
2006
Oct-July 2006
HUMAN GENOME SCIENCES ANNOUNCES PHASE 3 CLINICAL DEVELOPMENT PROGRAM FOR
ALBUFERON IN CHRONIC HEPATITIS C -
Roche HCV Polymerase Inhibitor: two preclinical
studies
The Nucleoside Inhibitor MK-0608 Mediates Suppression
of HCV Replication for >30 Days in Chronically Infected Chimpanzees
-
28 Days of the Hepatitis C Protease Inhibitor VX-950, in Combination With
PEG-Interferon-ALFA-2a and Ribavirin, Is Well-Tolerated and Demonstrates
Robust Antiviral Effects
Viramidine Did Not Meet Efficacy Endpoint in Viser2
-
NIM811, a Cyclophilin Inhibitor, Exhibits Potent In Vitro Activity against
Hepatitis C Virus Alone or in Combination with Alpha Interferon
-
Interferon Enhancer Drug EMZ702 Study + PegIFN/RBV
-
3 New Combination Therapies
SciClone Announces Disappointing Zadaxin Results
Preclinical Data on New HCV Protease Inhibitor ITMN
191
Celgosivir: Well-Tolerated, but Minimal Anti-HCV
Activity as Monotherapy
CPG 10101: Promising Data at 12 Weeks in Prior
Relapsers
Polymerase Inhibitor HCV-796 Demonstrates Potent
Antiviral Activity
New Phase 2 Studies of HCV Protease Inhibitor VX-950
Will Evaluate SVR Rates in Patients with HCV Genotype 1
In Nonresponders to Peginterferon/Ribavirin,
Valopicitabine + Peginterferon at Optimal Dosing Produces Significantly
Greater HCV Suppression Compared to Retreatment with Peginterferon Alfa
06-06-06
12 of 12
Patients Receiving Experimental HCV Protease Inhibitor VX 950 in Combination
with Pegasys Plus Ribavirin for 28 Days Experience Undetectable HCV RNA
Levels
- 5/23/06
FDA Grants Fast Track Review to Schering-Plough's New
Oral HCV Protease Inhibitor SCH 503034
Feb 15 2006
FDA Grants Fast Track
Designation to VX-950, an Experimental Oral Hepatitis C Virus Protease
Inhibitor from Vertex
Jan 05 2006
VX-950 Hep C Protease Inhibitor
The Era of Protease
Inhibitors for the Treatment of HCV: An Overview of SCH 503034
Pharmacokinetics and Safety of the Experimental, Oral
HCV Protease Inhibitor SCH 503034 in Healthy Subjects
SCH 503034 Suppresses Polyprotein Maturation and
Enhances the Antiviral Activity of Interferon Alfa-2b
Final Results of a Phase 1B, Multiple-dose Study of
VX-950, a Hepatitis C Virus Protease Inhibitor
Randomized Trial of Valopicitabine (NM 283), Alone or
with Peginterferon, vs Retreatment with Peginterferon Plus Ribavirin in
Nonresponders to Peginterferon Alfa
2005
Page One
SCH 503034, an Experimental
HCV Protease Inhibitor from Schering Plough, Shows Potent Anti-HCV Activity
in Patients Previously Failing on Peginterferon Alfa
Dec 2005
New HCV Protease Inhibitor
Locteron, New Interferon: Once Every Two weeks
Sep 03 2005
New Class of
Interferons Called Potentially 'Useful' Against Hep C
June 08 2005
Enrollment Completed for Phase IIb Trial of
Valopicitabine plus Pegasys Combination Therapy for HCV Genotype 1 Patients
Non-responsive to Peginterferon/Ribavirin
June 07 2005
Experimental HCV Protease
Inhibitor VX-950 Demonstrates Potent Anti-HCV Activity
May 17 2005
InterMune presents encouraging HCV drug data
May 17 2005
Hepatitis C Drug
Rocks Virus in Early Test
May 17 2005
New Hepatitis C Drugs in Development: 2005
EASL Report
May 2005
New HCV Therapies Show Promise: Etanercept and Lambda
Interferon
May 2005
Protease
Inhibitors: Restoring Immune Response in Hepatitis Patients
April 2005
Alpha-glucosidase inhibitors interfere with production, secretion, and
infectivity of hepatitis C viral particles in vitro
Page Two:
Viramidine Demonstrates
Anti-HCV Genotype 1 Activity That Compares Favorably to Ribavirin, But
without Complications of Severe Anemia
April 18 2005
Potency of Novel New
Nucleoside Valopicitabine Is Enhanced in Combination with Peginterferon in
Patients with HCV Genotype 1
April 18 2005
Phase II
Study Evaluates Albuferon, a Promising New Form of Interferon, for Treatment
of Hepatitis
April 18 2005
NEW HCV PROTEASE INHIBITOR STARTS FIRST 14-DAY HUMAN
STUDY IN NOVEMBER
Nov 14 2004
Results from First Human
Study of VX-950, an Experimental Oral HCV Protease Inhibitor
Nov 11 2004
Efficacy,
Safety and Pharmacokinetics of NM283, a New Polymerase Inhibitor for the
Treatment of Hepatitis C
Nov 01 2004
DISCOVERY
AND PRECLINICAL CHARACTERIZATION OF NOVEL INHIBITORS OF THE HCV NS3/4
PROTEASE
Page Three
Kenyan Gives New Hope
to Cancer Victims
Dr Njoroge developed a protease inhibitor that arrests critical steps
required for viral replication. The inhibitor stops the virus from cleaving
itself to produce more viruses, and this ultimately clears the Hepatitis C
viruses from the body.
Sept 24 2004
Actilon (CPG 10101)
Coley’s lead clinical product for the treatment of viral disease, induces
high levels of endogenous type I interferons and restores immune function
that may be compromised by viral infection. Actilon is currently in Phase
I/II trials for the treatment of chronic hepatitis C (HCV) infection.
Platelet sparing effect of COX II inhibition used with pegylated interferon
alfa-2a for the treatment of chronic hepatitis C: a short term pilot study.
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