NANOBIO COMPLETES PHASE II HERPES TRIAL

NanoBio has completed its Phase II study of NB-001 in patients with herpes labialis (cold sores) and is moving ahead with plans to conduct Phase III clinical trials next year. NB-001 is a topical emulsion comprised of nanometer-size water/oil droplets coated with a surfactant that has demonstrated potent antiviral, antibacterial and antifungal activity in previous studies. These uniformly small antimicrobial particles are designed to accelerate the healing of skin ulcers by killing the herpes viruses at the lesion site.

The multicenter Phase II study enrolled 332 patients with recurrent herpes labialis who were randomized to one of five 10-day treatment arms: no treatment, vehicle nanoemulsion, or one of three doses of active nanoemulsion. Patients who received the highest dose of NB-001 tended to show healing one day sooner than subjects in the control group. A significant proportion of subjects on the highest dose of NB-001 exhibited healing two or more days earlier than the control group. There were no drug-related adverse events, reports of drug-induced skin irritation or drop-outs due to adverse events.