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Pharmasset Announces the Continued Enrollment of the Phase 2b Clinical Trial of RG7128 for the Treatment of Hepatitis C
Date:11/23/2009

PRINCETON, N.J., Nov. 23 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that the enrollment of Cohort 2, led by its partner Roche (SWX: ROG.VX; RO.S, OTCQX: RHHBY), will continue for the remaining 300 genotype 1 and 4 patients in the ongoing phase 2b trial of RG7128, a first-in-class nucleoside analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The decision was reached after a scheduled review by an independent Data Monitoring Committee (DMC) of all available safety data from the first cohort of approximately 100 patients completing 8 or 12 weeks of RG7128 or matching placebo in combination with pegylated interferon and ribavirin.

The DMC reviewed any potential drug discontinuations, incidence and details of adverse events, and selected laboratory assessments. No safety events in the DMC review were considered significantly different from those expected from HCV patients taking pegylated interferon and ribavirin treatment. The committee expressed no safety concerns that would preclude enrollment of the remaining 300 patients in the ongoing phase 2b study in the HCV positive genotype 1 and 4 population, and have not recommended modification of dose or duration of any RG7128 dosing regimens. Enrollment of these patients pre-screened for this Cohort in the fourth quarter 2009 has begun and is expected to be complete by the end of the first quarter of 2010.

"We welcome Roche's decision to open enrollment of Cohort 2 for the remaining 300 patients in the phase 2b trial," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We are encouraged by the safety profile of RG7128 to date, which, when coupled with the higher barrier to resistance offered by nucleoside and nucleotide analog inhibitors has the potential to improve SVR rates over the
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Related medicine technology :

1. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
2. Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV
3. Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
4. Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
5. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
6. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
7. Pharmasset Reports First Fiscal Quarter 2008 Financial Results
8. Pharmasset Presents Results of 4-Week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
9. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
10. Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
11. Pharmasset Receives Notice of Allowance
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