NanoBio Corporation, announced today that it has successfully completed its Phase 2 study of NB-001 in patients with herpes labialis (cold sores) and is moving ahead with plans to conduct Phase 3 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 anti-viral, anti-bacterial and anti-fungal 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 multi-center Phase 2 study enrolled 332 patients with recurrent herpes labialis who were randomized to one of five ten-day treatment arms: no treatment, vehicle nanoemulsion, or one of three doses of active nanoemulsion. Patients who received the highest dose of NB-001 (0.1%) trended to show healing one day sooner than subjects in the control group. A significant proportion of subjects on the highest dose of NB-001 had 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.
“With nearly 150 million outbreaks of herpes in the United States each year and the increasing concern for the potential of resistance to currently-available drug therapies, there is a growing need to develop more effective treatments for these infections,” said Michael J. Nestor, chief executive officer of NanoBio. “We believe our findings demonstrate a clinically significant benefit from the highest dose of NB-001 and, therefore, provide the basis for conducting pivotal Phase 3 studies next year.”
NanoBio's chief scientific officer, James Baker, Jr., M.D., commented, “These results clearly validate the premise of the nanoemulsion technology platform on which NanoBio's treatments are based. These findings support us in moving forward with proposed product treatments for a broad range of topical infectious diseases.”
NanoBio plans to present its Phase 2 findings along with its plans for Phase 3 studies to the U.S. Food and Drug Administration later this year.
NanoBio Corporation is a biopharmaceutical company developing and commercializing therapies based on proprietary nanoemulsion technology. This technology was developed at the University of Michigan Medical School. NanoBio, a privately held corporation, is the exclusive global licensee of this technology.
In addition to NB-001, clinical trials with NB-002, a proposed treatment for nail fungus (onychomycosis), are planned for the first quarter of 2006. Other products in the NanoBio product development pipeline include treatments for genital herpes, herpes zoster (shingles) and a broad spectrum vaginitis treatment. NanoBio also is conducting pre-clinical activity on nanoemulsion based vaccines. NanoBio believes that its proposed products could have important therapeutic, safety and cost advantages over currently available treatments.
