Experimental Therapies:  New treatments for hepatitis C including pre-clinical development that have not yet been studied in humans, and various drugs that are in phase I, II and III development to treat hepatitis C.

 

·        Experimental

o       Actilon (CPG 10101)

§        96. Early Viral Response and On Treatment Response to CPG 10101 (ACTILONTM), in combination with pegylated interferon and/or ribavirin, in chronic HCV genotype 1 infected patients with prior relapse response (updated November 3, 2006)

§        1149. Combined immunomodulatory activities of the C-Class TLR9 agonist, CPG 10101, IFN-α and ribavirin on IFN-dependent and regulatory gene expression in human immune cells (updated October 31, 2006)

 

o       Albuferon

§        1136. Sustained Virologic Response Rates with albumin interferon alfa-2b in Combination with Ribavirin in Non-responders to Prior Interferon Therapy: Interim Results from a Phase 2 Study (updated November 1, 2006)

§        1140. Favorable Pharmacokinetics of albumin interferon alfa-2B in Subjects with Chronic Hepatitis C. (updated November 1, 2006)

§        1141. Interim Antiviral and Safety Data with albumin interferon alfa-2b Combined with Ribavirin in a Phase 2b Study Conducted in a Genotype 1, IFN-naļve, Chronic Hepatitis C Population (updated November 1, 2006)

 

o       Bavituximab

§        127. Phase I single-dose study of bavituximab, a chimeric anti-phosphatidylserine monoclonal antibody, in subjects with chronic hepatitis C

 

o       General

§        95. PF-03491390, (formerly IDN-6556) a Pancaspase Inhibitor, is Well-Tolerated and Effectively Reduces Raised Aminotransferases (ALT and AST) in Chronic Active Hepatitis C (HCV) Patients (pts)

§        1130. The cyclophilin inhibitor DEBIO-025 has a potent dual anti-HIV and anti-HCV activity in treatment-naļve HIV/HCV co-infected subjects (updated October 31, 2006)

§        1131. High-dose Pravastatin (Prava) 80mg/day is Associated with a Reduction in ALT values among Hypercholesterolemic Patients with Chronic Hepatitis C (CHCV) Infection: Analysis of a Prospective, Randomized , Double-blind, Placeo-controlled Trial (updated November 1, 2006)

§        1134. Final Results of pilot study evaluating safety, viral clearance and antifibrotic efficacy of treatment with Interferon γ1b + an Interferon α + Ribavirin in HCV patients who failed prior Pegylated Interferon + Ribavirin therapy (updated October 31, 2006)

§        1143. Effect of an IMPDH inhibitor, merimepodib (MMPD), assessed alone and in combination with ribavirin, on HCV replication: implications regarding ribavirin’s mechanism of action.

 

o       GI-5005

§        LB17. Interim Results from a Randomized, Double-blind, Placebo-controlled Phase 1b Study in Subjects with Chronic HCV after Treatment with GI-5005, a Yeast-Based HCV Immunotherapy Targeting NS3 and Core Proteins (updated November 2, 2006)

 

o       HCV-796

§        1127. Analysis of HCV NS5B Genetic Variants Following Monotherapy with HCV-796, a Non-Nucleoside Polymerase Inhibitor, in Treatment-Naļve HCV-Infected Patients (updated October 31, 2006)

 

o       ITMN-191

§        933. In Vitro Synergistic Antiviral Activity of ITMN-191, an Orally Active Inhibitor of the Hepatitis C Virus (HCV) NS3/4A Protease, in Combination with PEG-Interferon Alfa-2a (updated October 30, 2006)

 

o       R1626

§        928. In vitro antiviral interactions of a novel HCV inhibitor R1479 with interferon α-2a, ribavirin and other HCV inhibitors (updated October 30, 2006)

§        LB2. Results of a Phase 1B, Multiple Dose Study of R1626, a Novel Nucleoside Analog Targeting HCV Polymerase in Chronic HCV Genotype 1 Patients. (updated November 2, 2006)

 

o       Taribavirin (Viramidine)

§        1133. Impact Of Taribavirin And Ribavirin Exposure On Efficacy And Anemia Rates When Combined With Pegylated Interferon Alfa-2b In The Treatment Of Chronic HCV (updated November 1, 2006)

§        1146. Rapid Virologic Response (RVR) Is Enhanced by Higher Drug Exposure Among Patients Receiving Taribavirin in Combination With Pegylated Interferon alfa-2b for the Treatment of HCV Infection (updated October 31, 2006)

 

o       Telaprevir (VX-950)

§        89. In vitro Characterization of Telaprevir (VX-950) NS3 Protease Variants

§        92. Combination of Telaprevir (VX-950) and Peg-IFN-alfa Suppresses Both Wild-type Virus and Resistance Variants in HCV Genotype 1-Infected Patients in a 14-day Phase 1b study

§        129. Telaprevir (TVR, VX-950) resistance variants A156T/V exhibit reduced cleavage of innate immunity signaling proteins, TRIF and IPS-1

§        927. Current status of subjects receiving Peg-Interferon-Alfa-2a (Peg-IFN) and Ribavirin (RBV) Follow-on therapy after 28-Day treatment with the hepatitis C protease inhibitor TELAPREVIR (VX-950), Peg-IFN AND RBV (updated November 2, 2006)

§        1142. Current Status Of Subjects Receiving Peg-Interferon-Alfa-2a (Peg-IFN) And Ribavirin (Rbv) After A 14-Day Study Of The Hepatitis C Protease Inhibitor Telaprevir (VX-950), With Peg-IFN (updated October 31, 2006)

 

o       Valopicitabine (NM283)

§        93. Valopicitabine (NM283) plus Peg-Interferon in Treatment-Naļve Hepatitis C Patients with HCV Genotype-1 Infection: HCV RNA Clearance During 24 Weeks of Treatment

 

·        Pre-clinical

o       128. Discovery, Characterization and Anti-HCV Activity of a Novel NS5B Inhibitor

o       206. Identification of novel CTL epitopes in hepatitis C virus by genome-wide computational scanning and a rational design of peptide vaccine.

o       242. Ascites in HCV: A Previously Untapped Source of Antibodies

o       271. Immunization with Hepatitis C Virus-Like Particles Induces Partial Protection against Hepatitis C Virus Infection in Chimpanzees

o       317. Inhibition of Hepatitis C viral (HCV) replication by in-vivo dimerization of STAT1

o       406. The Antiviral Efficacy of an HCV Polymerase Inhibitor in the Chimpanzee Model: Genotypic and Phenotypic Analyses

o       412. Identification of human monoclonal antibodies against HCV E1 that broadly neutralize retroviral pseudoparticles and JFH1-based viruses

o       417. In vitro antiviral effects of combinations of Abbott HCV polymerase inhibitors with IFN or NS3/4A protease inhibitors

o       422. The C-terminus of the first structural domain of HCV and GBV-C NS5A protein inhibit HIV replication in Jurkat cells

o       432. Selection And Characterization Of Hepatitis C Virus Replicons Resistant To A Potent Polymerase Inhibitor A-837093

o       929. Development of a universal T-cell vaccine candidate for hepatitis C applicable to the majority of human HLA types and HCV genotypes. (updated October 30, 2006)

o       931. In Vitro Resistance Studies of AG-021541, a Novel Nonnucleoside Inhibitor of the Hepatitis C Virus RNA-dependent RNA Polymerase (updated October 30, 2006)

o       932. Assessment of the Pharmacological Activity of PEGylated Recombinant Interleukin-29 (PEG-rIL-29) in Cynomolgus Monkeys (updated October 30, 2006)

o       934. Preclinical Evaluation of SCY-635, a Cyclophilin Inhibitor with Potent anti-HCV Activity (updated October 30, 2006)

o       935. Robust Suppression of Viral Replication by a Nucleoside Polymerase Inhibitor in Chimpanzees Infected with Hepatitis C Virus (updated October 31, 2006)

o       936. Viral Dynamics Study with HCV NS3-4A Protease Inhibitor MP-424/VX-950 in Human-Chimeric Liver Mouse Model for Hepatitis C Virus Infection (updated October 31, 2006)

o       937. Induction Of Resistance By A Novel Class Of Compounds Active Against Hepatitis C Virus With No Cross-Resistance To NS3 Protease And NS5B Polymerase Inhibitors (updated October 31, 2006)