Apr 12 2010
Inhibitex, Inc. (Nasdaq: INHX) today announced that the independent Data Safety Monitoring Board (DSMB) responsible for reviewing safety data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with 30-day follow-up data on the first half of the patients that the Company plans to enroll in the trial. In addition, an independent statistician conducted a prospectively described interim analysis on the primary endpoint, which is the reduction in a composite of the severity and duration of shingles-associated pain over the first thirty (30) days of follow-up. Based upon the results of these reviews, the trial will continue, as originally designed, without modification. The Company, which remains blinded to the efficacy data, anticipates that top-line data from the completed trial will be available in the fourth quarter of 2010.
The Phase II trial is a well-controlled, double-blind study comparing two arms of FV-100, which the Company is developing for the treatment of shingles, to an active control (valacyclovir). The Company plans to enroll and randomize approximately 350 shingles patients, aged 50 years and older, equally to one of three treatment arms: 200 mg FV-100 administered once daily; 400 mg FV-100 administered once daily; and 1,000 mg valacyclovir administered three times per day. In addition to further evaluating its safety, the objectives of the trial are to evaluate the potential therapeutic benefit of FV-100 in reducing the severity and duration of shingles-associated pain, the incidence of post herpetic neuralgia (PHN), and the time to lesion healing.
SOURCE Inhibitex, Inc.,
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