The data represent a unique approach to treating nail fungus(onychomycosis), which resists topical therapies because they cannot penetratethe nail and access the site of infection. The results were reported thismorning at the 48th annual Interscience Conference on Antimicrobial Agents andChemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annualmeeting in Washington, D.C.

"In testing NB-002 on human cadaver skin, we have demonstrated that thelotion permeates and then laterally diffuses across tissue plains in theepidermis and the dermis to more than 1 centimeter away from the site ofapplication," said Susan Ciotti, Ph.D., director of formulations and researchand development, and presenting author of the data.

"The average great toenail measures 22 millimeters across, so we are ableto deliver NB-002 across the entire span of an infected human large toenail, ahuge advance in the treatment of onychomycosis," Ciotti said.

Because of its novel mode of penetration and diffusion, NB-002 is able toachieve 50 times the minimum drug concentration required to kill the fungus inthe very center of the nail bed. Only 4 micrograms per gram of tissue arerequired for NB-002 to kill fungal infections.

Newer, more effective therapies for nail fungus are important becauseonychomycosis remains a large unmet medical need, according to the NanoBioscientists. Oral systemic medications are plagued by serious hepatic andcardiac toxicity concerns, while current topical medications are not effectivebecause they are unable to penetrate to the site of infection.

"The safe and efficient delivery of NB-002 makes it an ideal candidate forthe treatment of onychomycosis," Ciotti said. "And because there is nosystemic absorption, NB-002 does not pose the risk of adverse events or druginteractions that systemic antifungal agents present."

NB-002 kills both active spores and developing hyphae, an additive effectthat lessens the fungi's ability to survive in human tissue, said James R.Baker, Jr., M.D., founder and chairman of NanoBio Corp. Studies conducted invitro demonstrate that NB-002 has robust antifungal activity against allorganisms that cause nail fungus, including Trichophyton rubrum, T.mentagrophytes, Epidermophyton floccosum, Microsporum canis and Candidaalbicans.

NanoBio scientists credit the topical lotion's safety and robustanti-infective activity to NB-002's novel technology platform. The lotion iscomposed of an oil-in-water emulsion and a commonly used antimicrobialsurfactant that are mixed at high speeds to nanosize the particles and infusethem with high levels of potential energy. The resulting nanodroplets easilypenetrate hair follicles and skin pores to reach the site of infection withoutdamaging or irritating skin or mucous membranes. Upon contact with thepathogen, the highly charged particles release their energy to the pathogen'souter membranes, disrupting the fungus.

NB-002 is currently being studied in a randomized, double-blind,placebo-controlled, phase 2 trial in more than 400 subjects withonychomycosis. Final results are expected in the first quarter of 2009.

About NanoBio

NanoBio(R) Corp. is a privately held biopharmaceutical company focused ondeveloping and commercializing anti-infective products and mucosal vaccinesderived from its patented NanoStat(TM) technology platform. The company's leadclinical product candidates are treatments for herpes labialis (cold sores),onychomycosis (nail fungus), acne, cystic fibrosis and mucosal vaccines forinfluenza and hepatitis B. Company headquarters and laboratory facilities arelocated in Ann Arbor, Mich.

SOURCE NanoBio Corporation