HCV Experimental Treatments

ACH 806 (HCV Protease Inhibitor) Albumin Interferon Boceprevir (aka SCH 503034) Celgosivir GS 9132 and GS 9190 HCV 759 (HCV Polymerase Inhibitor) HCV-796 (HCV Polymerase Inhibitor) ITMN 191 MK-0608 R-1626 and R-7128 Telaprevir (aka VX-950) TMC435350 Valopicitabine (aka NM 283) Viramidine (aka Taribavirin)

ACH 806 (HCV Protease Inhibitor)

In Vitro Studies Suggest Promising Outcomes with New HCV Protease Inhibitor ACH 806 in Combination with Interferon, Telaprevir, or NM 107 - 5/05/07

Albumin Interfern

Safety and Activity of Once-Monthly Albinterferon Alfa-2b (Albuferon) in Genotype 2/3 Chronic Hepatitis C Patients - 5/23/08

Antiviral Activity, Pharmacodynamics, and Quality of Life in Genotype 1 Hepatitis C Patients Treated with Albinterferon (Albuferon) - 5/23/08

Albuferon Dose in Ongoing Trials is Lowered Due to Safety Concerns - 1/25/08

Albumin Interferon May Be as Effective as Pegylated Interferon with Less Frequent Dosing - 5/05/07

Boceprevir (aka SCH 503034)

74 Percent of Genotype 1 HCV Patients in Experimental HCV PI Boceprevir Phase II Study Achieve Sustained Virologic Response (SVR) at 48 Weeks - 8/05/2008

Schering Plough Initiates Phase 3 Studies with Experimental Oral HCV Protease Inhibitor Boceprevir in Treatment-naive HCV Patients and in Those Who Failed Prior Treatment - 5/23/08

Boceprevir (NS3 Protease Inhibitor) Combination Therapy in Non Responders: Phase II Dose Finding Study - 4/29/08
E Schiff and others. EASL 2008.

Interim Results from HCV SPRINT-1: RVR/EVR from Phase 2 Study of Boceprevir Plus Peginterferon alfa-2b/Ribavirin in Treatment-Naïve Subjects with Genotype-1 CHC - 4/29/08
K Lawitz and others. EASL 2008.

Boceprevir Added to Pegylated Interferon/Ribavirin Increases Sustained Response in Treatment-naive Patients and Some Prior Non-responders - 4/29/08

Polymerase Inhibitor NM107 and Protease Inhibitor Boceprevir Show Enhanced Anti-HCV Activity in Combination - 12/07/07

Combination Therapy with HCV Protease Inhibitor Boceprevir Produces a High Rate of Early Virological Response in Genotype 1 Hepatitis C Patients - 10/23/07

Enhanced Clinical Effects and Favorable Resistance Profile with Combination of Boceprevir Plus HCV-796   - 5/20/07

Schering’s Experimental Oral HCV Protease Inhibitor Boceprevir Appears Safe in Patients with Varying Degrees of Liver Impairment - 5/05/07

Mutations That Confer Resistance to HCV Protease Inhibitors 5/05/07

Combining Experimental HCV Inhibitors Boceprevir and NM 107 Enhances Anti-HCV Activity and Suppresses Emergence of Resistance - 5/05/07

Mutations That Confer Resistance to HCV Protease Inhibitors 5/01/07

In Vitro Studies Suggest Promising Outcomes with New HCV Protease Inhibitor ACH 806 in Combination with Interferon, Telaprevir, or NM 107 4/05/07

Update on Clinical Development Program for HCV Protease Inhibitor SCH 503034 - 4/28/06

THE HCV NS3 PROTEASE INHIBITOR SCH 503034 IN COMBINATION WITH PEG-IFN-ALPHA-2B IN THE TREATMENT OF HCV-1 PEG-IFN-ALPHA-2B NON-RESPONDERS: ANTIVIRAL ACTIVITY AND HCV VARIANT ANALYSIS - 4/28/06

Open Clinical Trial of New PI SCH 503034 Plus PegIntron in HCV Patients Nonresponsive to Prior Treatment with Peginterferon Plus Ribavirin - 2/17/06

Celgosivir

Adding Celgosivir to Standard Hepatitis C Therapy Increases the Likelihood of Early Response Rate in Prior Non-responders - 5/05/07

Celgosivir: Well-Tolerated, but Minimal Anti-HCV Activity as Monotherapy - 6/06/06

GS 9132 and GS 9190

Experimental HCV Polymerase Inhibitor GS 9190 Shows Promising Antiviral Activity but Possible Cardiac Side Effects in Phase 1 Study - 12/11/07

Despite Promising Early Data, Companies Discontinue Experimental HCV Protease Inhibitor GS 9132 - 2/13/07

Gilead and Achillion Announce Start of Phase 1 Clinical Trial of GS 9132, an HCV Protease Inhibitor for the Treatment of Hepatitis C - 8/24/05

HCV-796 (HCV Polymerase Inhibitor)

ViroPharma and Wyeth Halt Development of HCV-796 for Hepatitis C - 4/24/08

Novel HCV Polymerase Inhibitor VCH-759 Monotherapy Demonstrates Promising Antiviral Activity - 12/07/07

Experimental Polymerase Inhibitor HCV-796 is Safe and Effective in Combination with PegIntron or Pegasys - 12/07/07

HCV-796 Plus PegIntron Shows Greater Antiviral Activity Across All HCV Genotypes Than Either Agent Used Alone   - 5/20/07

Enhanced Clinical Effects and Favorable Resistance Profile with Combination of Boceprevir Plus HCV-796   - 5/20/07

HCV-796 Shows Antiviral Activity in Combination with Pegylated Interferon - 5/05/07

Experimental Agent HCV-796 Shows Activity in Preclinical Studies - 10/03/06

HCV Polymerase Inhibitor VCH-759

Novel HCV Polymerase Inhibitor VCH-759 Monotherapy Demonstrates Promising Antiviral Activity - 12/07/07

ITMN 191 and ANA598 (HCV Polymerase Inhibitor)

InterMune and Anadys Begin Phase 1 Clinical Trials of Experimental HCV Therapies ITMN-191 and ANA598 - 6/06/08

InterMune Presents Top-line Results from Phase 1b Trial of HCV Protease Inhibitor ITMN-191 Monotherap - 4/04/08

InterMune Announces Progress on HCV Protease Inhibitor ITMN-191 - 1/11/08

Preclinical Study Shows ITMN-191 Plus Pegasys is Active against HCV In Vitro   11/10/06

Roche and InterMune to Collaborate on HCV Protease Inhibitor ITMN-191   10/24/06

Preclinical Data on New HCV Protease Inhibitor ITMN 191- 6/02/06

MK-06080 (HCV Nucleoside Inhibitor)

Experimental Nucleoside Inhibitor MK-0608 Suppresses HCV Replication in Chimpanzees   9/29/06

R-1626 and R7128 (HCV Polymerase Inhibitor)  

Pharmasset Releases Preliminary Data from Phase 1 Study of Investigational HCV Polymerase Inhibitor R7128 - 8/08/2008

R7128 Demonstrates Potent Anti-HCV Activity in Combination with Pegylated Interferon/Ribavirin; Ongoing Trial to be Expanded - 4/29/08

HCV Polymerase Inhibitor R1626 Produces Good Response with Pegylated Interferon/Ribavirin and Has High Barrier to Resistance - 4/29/08

Pharmasset Announces Promising 4-Week Data on Combination Therapy with HCV Polymerase Inhibitor R7128 - 1/11/08

HCV Polymerase Inhibitor R7128 Demonstrates Antiviral Activity in Prior Non-responders - 12/14/07

Pharmasset Completes Enrollment for Phase 1 Study of Experimental Nucleoside Polymerase Inhibitor R7128 for Treatment of Chronic Hepatitis C   - 8/07/07

Pharmasset and Roche Initiate New Toxicology Studies of HCV Polymerase Inhibitor R7128    - 7/13/07

Roche Polymerase Inhibitor R1626 Demonstrates Antiviral Activity and Good Safety in Phase I Study   11/10/06

HCV Polymerase Inhibitor R-1626 Advances to Phase II Study 10/17/06

Valopicitabine (HCV Polymerase Inhibitor)

Two Studies Yield Mixed Results for HCV Polymerase Inhibitor Valopicitabine - 5/05/07

Valopicitabine Dosed in Combination with Pegylated Interferon Alfa-2a (Pegasys) Leads to Rapid Virologic Response in 93 percent of Genotype 1 Hepatitis C Patients - 1/05/06

Lower Dose of Valopicitabine plus Pegylated Interferon Shows Antiviral Activity with Fewer Side Effects - 11/15/06

Valopicitabine plus Peginterferon Alfa-2a (Pegasys) Is More Effective in Nonresponders Compared to Peginterferon alfa-2a/Ribavirin Combination Treatment - 5/12/06

Randomized Trial of Valopicitabine (NM 283), Alone or with Peginterferon, vs Retreatment with Peginterferon Plus Ribavirin in Nonresponders to Peginterferon Alfa - 11/14/05

No Effect of Pegylated Interferon Alfa-2b (PegIntron) on the Pharmacokinetics of Valopicitabine (NM 283) in Chronic HCV Patients - 11/14/05

Encouraging Interim Results of Phase II Study of Valopicitabine (NM-283) in Combination with Peginterferon Alfa in Patients with HCV Genotype 1 - 1/05/05

Viramidine (Taribavirin)

Taribavirin Efficacy Similar to Ribavirin in Combination Therapy for Hepatitis C, but with Less Anemia - 5/09/08

Valeant Reports Promising 12-week Phase IIb Data on Taribavirin - 4/01/08

Virological Response and Safety Outcomes in Chronic Hepatitis C Patients Treated with Pegylated Interferon plus Taribavirin (Viramidine)   - 8/10/07

Hepatitis C Drug Viramidine Fails Pivotal Phase III Trial, Again   9/15/06

Valeant Announces Results of Phase 3 VISER 1 Trial Results of Viramidine versus Ribavirin - 3/24/06

TMC435350

Experimental HCV Protease Inhibitor TMC435350 Demonstrates Promising Activity and Tolerability in Early Clinical Trial - 5/13/08

Telaprevir (aka VX-950)  monotherapy / combination

Vertex Reports Encouraging Data from PROVE3 Trial of HCV Protease Inhibitor Telaprevir (VX-950) - 6/13/08

Telaprevir plus Pegylated Interferon and Ribavirin Allows Shorter Therapy for Patients with Genotype 1 HCV - 4/26/08

Vertex to Start Phase 3 Trials of HCV Protease Inhibitor Telaprevir (VX-950) - 2/01/08

Telaprevir plus Pegylated Interferon Is Effective against Both Wild-type and Drug-resistant HCV Strains   - 8/17/07

Mutations That Confer Resistance to HCV Protease Inhibitors 5/01/07

Telaprevir-based Therapy for HCV May Shorten Treatment Duration from 48 to 24 Weeks for Some Genotype 1 Patients - 4/17/07

In Vitro Studies Suggest Promising Outcomes with New HCV Protease Inhibitor ACH 806 in Combination with Interferon, Telaprevir, or NM 107 4/05/07

Telaprevir Demonstrates Safety and Anti-HCV Activity in 12-week Interim Analysis 1/05/07

Telaprevir Resistance Mutations Observed in Laboratory Studies  12/05/06

Updated Results from Patients Receiving Standard HCV Therapy Following Telaprevir  12/01/06

Telaprevir plus Pegylated Interferon Suppresses Wild-type and Resistant HCV Over 14 Days  11/03/06

Rapid Decline of HCV RNA in Patients Treated with VX-950 10/02/06