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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

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.