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Posted: September 19, 2007
New Topical Therapy Safely Treats Serious Skin Infections Without Systemic Side Effects
(Nanowerk News) A new topical lotion that
penetrates the skin deeply enough to target and eliminate serious skin
infections, but without being systemically absorbed, has shown a high
degree of 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 of
dermatology and infectious diseases because currently approved systemic
medications for onychomycosis carry serious risks of cardiac and liver
toxicity," said James Baker, MD, chief science officer and founder of
NanoBio Corporation in Ann Arbor, Mich. NanoBio scientists developed the
The phase 1 data for the new lotion, NB-002, will be presented at the
47th Annual 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
untreated as a result of concerns for the serious toxicities associated
with the available oral medications," said Baker. "Our safety data,
combined with early information from the ongoing phase 2 trial, indicate
that NB-002 is potentially the first treatment for onychomycosis that is
highly efficacious and very safe."
NanoBio Corporation is a spin-off from the University of Michigan. The
company develops novel anti-infective products and mucosal vaccines to
treat or prevent a wide range of infections, from cold sores and toenail
fungus to influenza and hepatitis B. Its lead products are NB-001 to treat
herpes labialis and NB-002 to treat onychomycosis.
NB-002 is a topical oil-in-water nanoemulsion combined with an
antimicrobial agent commonly used in oral products to treat gingivitis and
other conditions of the mouth and throat. The nanoemulsion undergoes a
high- energy process to shrink or "nano-size" the particles so they are
small enough to enter the skin through pores and hair follicles but too
large to penetrate the tight junctions of the epithelium.
As a result, NB-002 is not systemically absorbed, as the phase 1 study
has demonstrated. In the study, 20 subjects with advanced onychomycosis
were randomized to receive two strengths of NB-002. Treatments were applied
twice daily for 28 days to both affected and unaffected toenails and a
small area of surrounding skin. Blood samples were collected periodically
to determine if the drug was absorbed systemically.
Results showed the drug was below the quantifiable limit of systemic
absorption for all subjects throughout the study period. Additionally, the
trial showed that, unlike the current treatments for onychomycosis, NB-002
had no safety or dermal irritation concerns.
Results of a phase 2 clinical trial for onychomycosis are expected in
In addition to its topical agents, NanoBio is developing a rich
pipeline of needle-free vaccines based on using the same oil-in-water
emulsion technology as an adjuvant. Mucosal vaccines against influenza and
hepatitis are scheduled for human testing beginning next year, while an
anthrax vaccine has demonstrated safety and strong efficacy in animal
NanoBio(R) Corporation 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 product candidates are treatments for herpes
labialis (cold sores), onychomycosis (nail fungus), methicillin-resistant
Staphylococcus aureus (MRSA) and mucosal vaccines for influenza and
hepatitis B. The company's headquarters and laboratory facilities are
located in Ann Arbor, Mich.
Poster presentation M-1819, Tolerability, Safety and Pharmacokinetics
of Topical Nanoemulsions (NB-002) in Patients With Onychomycosis, is
scheduled for Session #188, 9/19/2007, at 12:15 - 4:00 pm, Title: