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Roche/Pharmasset HCV Polymerase Drug New Patient Study Results Expected in September
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Pharmasset Completes Enrollment of Phase 1 Study of R7128 for HCV
- Anticipate Preliminary 14-day Multiple Ascending Dose Efficacy Data in September 2007 -
PRINCETON, N.J., Aug 02, 2007 /PRNewswire-FirstCall via COMTEX News Network/ --
Pharmasset, Inc. (Nasdaq: VRUS) has completed patient enrollment of the ongoing multiple ascending dose study of R7128 for the treatment of hepatitis C virus (HCV). R7128, a nucleoside polymerase inhibitor of HCV, is currently being evaluated in a Phase 1 clinical trial as part of Pharmasset's collaboration with Roche. The primary objective of the multiple ascending dose study is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice- daily dosing for 14 days in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA in these patients.
Pharmasset expects to release preliminary 14-day safety and efficacy treatment data from the multiple ascending dose study in September 2007. Results for the entire Phase 1 single ascending and multiple ascending dose study are expected to be presented at various scientific conferences throughout the remainder of 2007. As recently announced, Roche has initiated long-term chronic toxicology studies in support of the potential advancement of R7128 into Phase 2 clinical trials.
About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
* Part 1 is a single ascending dose study conducted in 38 healthy
volunteers. The primary objective of Part 1 is to assess the safety,
tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128.
* Preliminary data from the single ascending dose portion of the study indicate:
-- All doses of R7128 studied were generally well-tolerated.
-- All patients completed the study with no gastrointestinal adverse
events or serious adverse events reported during the study.
-- No hematological or laboratory abnormalities of clinical
significance were noted.
* Part 2 is a multiple ascending dose study being conducted in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates: Clevudine for the treatment of chronic HBV infection, which is expected to enter US, European and South American Phase 3 registration clinical trials and is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir; R7128, an oral treatment for HCV, in a Phase 1 clinical trial through a strategic collaboration with Roche; and Racivir for the treatment of HIV in combination with other approved HIV drugs, which has completed a Phase 2 clinical trial.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
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