vertex

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Summary of current clinical trials using Telaprevir for hep C
Last updated: 07 August 2009

Treatment-naïve Phase 3 trials

Vertex is conducting the Phase 3 ADVANCE study, which is evaluating the hepatitis C virus (HCV) protease inhibitor telaprevir, or placebo, as part of a 24-week combination regimen with pegylated interferon (peg-IFN) and ribavirin (RBV) in more than 1,050 genotype 1 treatment-naïve HCV patients. Based upon the completion of enrollment in October 2008, the telaprevir dosing portion of the ADVANCE trial is complete, and all patients are now beyond week 24 of the study. Patients receiving telaprevir-based regimens in the ADVANCE study will receive 24 or 48 weeks of total therapy, depending on whether they have undetectable virus levels at weeks 4 and 12 of treatment. The ADVANCE trial will remain blinded through the last patient completing week 72 in the study. The Company expects sustained viral response (SVR) 24 data to become available from ADVANCE in the first half of 2010.
Vertex is also conducting ILLUMINATE, a global two-arm trial that is evaluating response-guided telaprevir-based regimens in approximately 500 genotype 1 treatment-naïve HCV patients. This trial is designed to supplement SVR data obtained from the pivotal Phase 3 ADVANCE trial. The aim of the ILLUMINATE trial is to characterize whether there is an additional benefit to extending treatment from 24 to 48 weeks in treatment-naïve patients who achieved undetectable virus levels at weeks 4 and 12 of treatment (eRVR). Based upon the completion of enrollment in January 2009, the telaprevir dosing portion of the ILLUMINATE trial is complete, and all patients are now beyond week 24 of the study. The Company expects SVR24 data to become available from ILLUMINATE in the first half of 2010.
Treatment-failure Phase 3 trial

Vertex’s collaborator Tibotec is conducting the Phase 3 REALIZE trial, which is evaluating treatment with telaprevir-based regimens in more than 650 patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment, and which enrolled all major treatment-failure groups including null responders. Based upon the completion of enrollment in February 2009, the telaprevir dosing portion of the REALIZE trial is complete, and all patients are now beyond week 20 of the study. The Company expects SVR24 data to become available from REALIZE in mid-2010.
Telaprevir twice-daily evaluation

Vertex expects that final SVR24 data from Study C208, which is evaluating twice-daily telaprevir dosing, will be presented at a Presidential Plenary session at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Oct. 30 - Nov. 3 in Boston. Study C208 is a Phase 2, open-label clinical study being conducted by Tibotec in Europe that is evaluating a twice-daily (1125mg q12h) dosing schedule of telaprevir in combination with peg-IFN-alfa-2a (PEGASYS) or peg-IFN-alfa-2b (PEGINTRON™) and RBV, as compared to the current three-times-daily (750mg q8h) telaprevir dosing schedule. All dosing of study medications was completed in Study C208 in April. Patients are now in the post-treatment follow-up phase to determine the number of patients who achieve an SVR24 with twice-daily compared to three-times-daily dosing of telaprevir.
Additional telaprevir clinical studies

Vertex has completed PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment. Full data from PROVE 3 have been provided to the U.S. Food and Drug Administration.
All patients in Study 107, an open-label Phase 2 study to evaluate telaprevir-based combination regimens in patients who did not achieve an SVR in the 48-week control arms of the Phase 2 PROVE studies, have completed 24 weeks of dosing. In the study, telaprevir was given in combination with peg-IFN and RBV for 12 weeks followed by peg-IFN and RBV for 12 weeks or 36 weeks depending on the patient’s antiviral response to telaprevir in Study 107 and whether the patient was a prior non-responder, partial-responder or relapser. Vertex anticipates that additional data, including SVR24 data, from Study 107 will become available in 2010.
STAT-C combination therapies

Vertex is seeking to advance HCV therapy through the development of novel combinations of Specifically-Targeted Antiviral Therapies for hepatitis C (STAT-Cs). The Company plans to begin a combination trial of telaprevir with the HCV polymerase inhibitor VX-222 (formerly VCH-222) in patients with genotype 1 HCV as early as the fourth quarter of 2009.
Vertex expects data from this first STAT-C combination study to become available in the first half of 2010.
Vertex is currently conducting a three-day, multiple-dose viral kinetic study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of VX-222 dosed as a monotherapy in 32 treatment-naïve patients with genotype 1 HCV infection. This study is scheduled for completion in the third quarter of 2009. Additionally, Vertex expects to initiate a drug-drug interaction study with VX-222 and telaprevir in healthy volunteers in the third quarter of 2009.
Additional HCV compounds in clinical development

Vertex is conducting early-stage development activities with novel HCV compounds, including the additional HCV protease inhibitors VX-813 and VX-985 as well as the HCV polymerase inhibitor VX-759 (formerly VCH-759). Vertex also has an NS5A inhibitor program in preclinical development. The goal of these programs is to identify compounds that are appropriate for further development, including combination therapy.
AASLD

Three abstracts related to telaprevir have been accepted for presentation at AASLD, Oct. 30 - Nov. 3 in Boston, including an abstract representing Study C208. Study C208 is evaluating twice-daily dosing of telaprevir and will be presented at AASLD as part of an oral Presidential Plenary session on November 3.

[banarep]

cool.  am in realize study.