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-- Two 4-week cohorts will be enrolled to evaluate R7128 1500mg BID in HCV genotypes 2 and 3 prior non-responders and R7128 1000mg BID in HCV genotype
1 treatment-naive patients -- -- Conference call scheduled for Friday, April 25, 2008 at 1:00 PM ET (US)
and 7:00 PM CEST (Milan) --
PRINCETON, N.J. and MILAN, Italy, April 24 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) will enroll two additional cohorts in the on- going Phase 1 study protocol to evaluate 4 weeks of combination therapy with R7128. R7128, a prodrug of PSI-6130, is a nucleoside analogue polymerase inhibitor of hepatitis c virus (HCV) that is being developed through Pharmasset's collaboration with Roche.
Cohort 3 will study R7128 1000mg BID in treatment-naive patients with HCV genotype 1. This cohort is intended to provide clinical antiviral activity data in support of pharmacokinetic models from earlier studies. Cohort 4 will study R7128 1500mg BID in patients with HCV genotypes 2 and 3 who did not achieve a sustained virologic response (SVR) with previous interferon-based therapy. Cohorts 3 and 4 will both be dosed in combination with Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin).
Patients in Cohorts 3 and 4 are scheduled to begin dosing by the end of May 2008. Preliminary safety and antiviral activity data from the 4-week combination studies are anticipated during the 3rd quarter of 2008. Cohorts 3 and 4 will be conducted in parallel with the global Phase 2b study preparation activities for R7128. The timing of the Phase 2b study is not dependent upon data from Cohorts 3 and 4.
"Our pharmacokinetic modeling of the 500mg and 1500mg cohorts of R7128
in combination with Pegasy
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