A novel topical therapy for nail
fungus, NB-002, has demonstrated a new topical approach to healing nail
fungus by penetrating skin pores and diffusing through the skin that
surrounds the entire nail plate, according to a study conducted by NanoBio
Corporation.
The data represent a unique approach to treating nail fungus
(onychomycosis), which resists topical therapies because they cannot
penetrate the nail and access the site of infection. The results were
reported this morning at the 48th annual Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society
of America (IDSA) 46th annual meeting in Washington, D.C.
"In testing NB-002 on human cadaver skin, we have demonstrated that the
lotion permeates and then laterally diffuses across tissue plains in the
epidermis and the dermis to more than 1 centimeter away from the site of
application," said Susan Ciotti, Ph.D., director of formulations and
research and development, and presenting author of the data.
"The average great toenail measures 22 millimeters across, so we are
able to deliver NB-002 across the entire span of an infected human large
toenail, a huge advance in the treatment of onychomycosis," Ciotti said.
Because of its novel mode of penetration and diffusion, NB-002 is able
to achieve 50 times the minimum drug concentration required to kill the
fungus in the very center of the nail bed. Only 4 micrograms per gram of
tissue are required for NB-002 to kill fungal infections.
Newer, more effective therapies for nail fungus are important because
onychomycosis remains a large unmet medical need, according to the NanoBio
scientists. Oral systemic medications are plagued by serious hepatic and
cardiac toxicity concerns, while current topical medications are not
effective because they are unable to penetrate to the site of infection.
"The safe and efficient delivery of NB-002 makes it an ideal candidate
for the treatment of onychomycosis," Ciotti said. "And because there is no
systemic absorption, NB-002 does not pose the risk of adverse events or
drug interactions that systemic antifungal agents present."
NB-002 kills both active spores and developing hyphae, an additive
effect that 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 in vitro demonstrate that NB-002 has robust antifungal activity
against all organisms that cause nail fungus, including Trichophyton
rubrum, T. mentagrophytes, Epidermophyton floccosum, Microsporum canis and
Candida albicans.
NanoBio scientists credit the topical lotion's safety and robust
anti-infective activity to NB-002's novel technology platform. The lotion
is composed of an oil-in-water emulsion and a commonly used antimicrobial
surfactant that are mixed at high speeds to nanosize the particles and
infuse them with high levels of potential energy. The resulting
nanodroplets easily penetrate hair follicles and skin pores to reach the
site of infection without damaging or irritating skin or mucous membranes.
Upon contact with the pathogen, the highly charged particles release their
energy to the pathogen's outer 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 with
onychomycosis. Final results are expected in the first quarter of 2009.
About NanoBio
NanoBio(R) Corp. is a privately held biopharmaceutical company focused
on developing and commercializing anti-infective products and mucosal
vaccines derived from its patented NanoStat(TM) technology platform. The
company's lead clinical product candidates are treatments for herpes
labialis (cold sores), onychomycosis (nail fungus), acne, cystic fibrosis
and mucosal vaccines for influenza and hepatitis B. Company headquarters
and laboratory facilities are located in Ann Arbor, Mich.
NanoBio Corporation
nanobio
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