Herpes zoster,also known as shingles, results from the reactivation of the same virus that causes chickenpox (varicella zoster virus). There are over 2.5 million cases of shingles worldwide each year, about half of which occur in the U.S. Shingles causes a painful vesicular rash, or lesions, that generally take two to four weeks to heal. Further, approximately 90% of all shingles patients will experience shingles associated pain, and approximately 20% will develop painful, and often debilitating, post-herpetic neuralgia (PHN), which is shingles-associated pain that lasts 90 days or more. Both the incidence of shingles and PHN increases with age, with approximately 50% of all shingles cases occur in persons over 60 years of age.

FV-100 is a bicyclic nucleoside analogue we are developing for the treatment of herpes zoster (shingles) and the reduction of shingles-associated accute pain and PHN. In pre-clinical studies, FV-100 has proven to be the fastest acting and most potent antiviral available against herpes zoster.

We have completed several Phase I clinical trials of FV-100. These trials include single and multiple ascending dose studies aged 18-55, and a separate study conducted in studies 65 years of age or older. The studies showed FV-100 to be well tolerated at all dose levels and the pharmacokinetic data support evaluation of once-a-day dosing. We are currently conducting a Phase II trial of FV-100 in 350 shingles patients 50 years and older with active herpes zoster. For more information about this trial, please go to www.ClinicalTrials.gov.