Shingles, also know as herpes zoster, is an infection caused by the reactivation of varicella zoster virus or VZV, the same virus that causes chicken pox. It causes skin lesions, rash and acute pain. Worldwide, it is estimated that there are in excess of 2.5 million cases of shingles each year.
Based on the results, the company plans advance FV-100 into a second Phase 1 trial in additional single ascending and multiple ascending doses in health volunteers in the first half of 2008. Inhibitex expects potential for FV-100 to be dosed once-a-day and to reduce the incidence or severity of shingles-related symptoms, including acute pain and post herpetic neuralgia.
The company said the blinded, placebo-controlled single ascending dose study evaluated the safety and pharmacokinetics of 10, 20 and 40 mg oral doses of FV-100 in healthy volunteers. The study was conducted under an exploratory Investigational New Drug Application. Each of the three dose cohorts was given to six subjects and two were received placebo. Inhibitex plans to present the full data from the Phase 1 trial at a scientific meeting in 2008. The Company said the compound appeared to be generally well tolerated in the trial.
Commenting on outcome, Russel Plumb, president and chief executive officer of Inhibitex said, "We are very encouraged by the data from this first-in-man study and, in particular, the pharmacokinetic data, which clearly demonstrate that FV-100 is orally available."
INHX finished Thursday's regular trading session at $0.91, down $.01 on a volume of 182K shares. In the pre-market hours shares are up $0.0499, up 5.48% and traded at $0.9599.
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