Published on July 23, 2010 at 3:12 AM
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 complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB recommended that the trial continue to completion without modification. The Company anticipates that top-line efficacy 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 to an active control (valacyclovir) in the treatment of shingles, also referred to as herpes zoster. The Company plans to enroll and equally randomize approximately 350 patients, aged 50 years and older, 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.,