A new topical lotionthat penetrates the skin deeply enough to target and eliminate serious skininfections, but without being systemically absorbed, has shown a high degreeof safety and tolerability in patients with onychomycosis, or toenail fungus,a new study has shown.
"Results of the phase 1 clinical trial are important to the fields ofdermatology and infectious diseases because currently approved systemicmedications for onychomycosis carry serious risks of cardiac and livertoxicity," said James Baker, MD, chief science officer and founder of NanoBioCorporation in Ann Arbor, Mich. NanoBio scientists developed the lotion.
The phase 1 data for the new lotion, NB-002, will be presented at the 47thAnnual Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) meeting, to be held Sept. 17 -20, 2007, in Chicago.
"At present, the vast majority of people with onychomycosis are untreatedas a result of concerns for the serious toxicities associated with theavailable oral medications," said Baker. "Our safety data, combined with earlyinformation from the ongoing phase 2 trial, indicate that NB-002 ispotentially the first treatment for onychomycosis that is highly efficaciousand very safe."
NanoBio Corporation is a spin-off from the University of Michigan. Thecompany develops novel anti-infective products and mucosal vaccines to treator prevent a wide range of infections, from cold sores and toenail fungus toinfluenza and hepatitis B. Its lead products are NB-001 to treat herpeslabialis and NB-002 to treat onychomycosis.
NB-002 is a topical oil-in-water nanoemulsion combined with anantimicrobial agent commonly used in oral products to treat gingivitis andother conditions of the mouth and throat. The nanoemulsion undergoes a high-energy process to shrink or "nano-size" the particles so they are small enoughto enter the skin through pores and hair follicles but too large to penetratethe tight junctions of the epithelium.
As a result, NB-002 is not systemically absorbed, as the phase 1 study hasdemonstrated. In the study, 20 subjects with advanced onychomycosis wererandomized to receive two strengths of NB-002. Treatments were applied twicedaily for 28 days to both affected and unaffected toenails and a small area ofsurrounding skin. Blood samples were collected periodically to determine ifthe drug was absorbed systemically.
Results showed the drug was below the quantifiable limit of systemicabsorption for all subjects throughout the study period. Additionally, thetrial showed that, unlike the current treatments for onychomycosis, NB-002 hadno safety or dermal irritation concerns.
Results of a phase 2 clinical trial for onychomycosis are expected inearly 2008.
In addition to its topical agents, NanoBio is developing a rich pipelineof needle-free vaccines based on using the same oil-in-water emulsiontechnology as an adjuvant. Mucosal vaccines against influenza and hepatitisare scheduled for human testing beginning next year, while an anthrax vaccinehas demonstrated safety and strong efficacy in animal studies.
NanoBio(R) Corporation is a privately held biopharmaceutical companyfocused on developing and commercializing anti-infective products and mucosalvaccines derived from its patented NanoStat(TM) technology platform. Thecompany's lead product candidates are treatments for herpes labialis (coldsores), onychomycosis (nail fungus), methicillin-resistant Staphylococcusaureus (MRSA) and mucosal vaccines for influenza and hepatitis B. Thecompany's headquarters and laboratory facilities are located in Ann Arbor,Mich.
Poster presentation M-1819, Tolerability, Safety and Pharmacokinetics ofTopical Nanoemulsions (NB-002) in Patients With Onychomycosis, is scheduledfor Session #188, 9/19/2007, at 12:15 - 4:00 pm, Title: Ant