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NanoBio Corporation Presents Preclinical And Interim Clinical Data On Topical Treatments For Herpes Labialis And Onychomycosis At AAD 2008
NanoBio Corporation is
presenting safety and efficacy results on new topical treatments for herpes
labialis (cold sores) and onychomycosis (toe nail fungus) at the annual
meeting of the American Academy of Dermatology (AAD), being held February
1-5, 2008, in San Antonio.
The data being presented indicate that the company's topical lotions,
composed of nanometer-sized droplets, have potent antiviral and antifungal
effects without safety concerns or systemic absorption. Interim findings in
subjects with cold sores demonstrate faster healing without skin irritation
or safety concerns. Initial results in subjects with toe nail fungus
indicate an excellent safety profile with no systemic absorption coupled
with an ability to kill the fungi that cause onychomycosis, a common
condition affecting up to 36 million people.
"We are very encouraged by our preliminary results," said James R.
Baker Jr., M.D., founder and chairman of NanoBio Corporation. "Our human
and animal studies show that NanoBio's products are well tolerated and
without safety issues, adverse events or skin irritation concerns.
Pharmacokinetic studies show no systemic absorption, a factor that enhances
the safety profile."
Final results from a prior phase 2A study in herpes labialis, as well
as interim findings from an ongoing phase 2B study, indicate a significant
improvement in time to healing for subjects treated with NanoBio's
antiviral product, NB-001.
Results from a phase 1 study in onychomycosis, as well as preclinical
data being presented at the meeting, indicate that NanoBio's antifungal
product, NB-002, can be safely applied to the skin at doses more than 1,000
times higher than the minimum concentration required to kill fungi.
"NB-002 exerts its effect locally by penetrating the skin and diffusing
laterally underneath the nail plate to reach the dermatophytes and kill
both active hyphae and spores -- without irritating the epithelium or being
systemically absorbed," Baker said. "The absence of systemic involvement
could provide a significant advance for onychomycosis therapy in terms of
safety." Current oral (systemic) drugs for onychomycosis pose risks of
hepatic and cardiac toxicity, as well as the potential for drug
interactions, Baker added.
In addition to its safety and tolerability, NB-002 activity was
documented against numerous fungi involved in cutaneous infections,
including Candida albicans, Microsporum canis, Epidermophyton floccosum,
Trichophyton mentagrophytes and Trichophyton rubrum.
NanoBio is currently conducting a double-blind, placebo-controlled,
phase 2 study to further investigate the efficacy and safety of NB-002 in
443 subjects with onychomycosis. All subjects have been enrolled, and the
study is expected to be completed in February 2009.
The company's topical treatments are based on a novel anti-infective
platform comprising an oil-in-water emulsion and a surfactant. The
nanodroplets readily penetrate hair follicles and skin pores to reach the
site of infection without disrupting skin or mucous membranes. Upon contact
with the pathogen, the nanodroplets directly interact with the pathogen's
outer membranes to lyse the virus, fungus or bacteria.
Poster Titles -- Link to posters at http://www.nanobio.com
-- Safety, Tolerance, Pharmacokinetics, and Efficacy of Topical
Nanoemulsion NB-001 for the Treatment of Herpes Labialis
-- Development of a Novel Antiviral Drug (NB-001) for Topical Application
in Humans
-- Safety, Tolerance, and Pharmacokinetics of Topical Nanoemulsion (NB-
002) for the Treatment of Onychomycosis
-- Development of a Novel Antifungal Drug (NB-002) for Topical Application
in Humans
About NanoBio
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), MRSA and mucosal
vaccines for influenza and hepatitis B. The company's headquarters and
laboratory facilities are located in Ann Arbor, Mich.
NanoBio Corporation
http://www.nanobio.com
NanoBio Corporation a prezentat preclinice ºi clinice, a datelor interimare pe topic tratamente pentru herpes Labialis ºi Onychomycosis la AAD 2008 - NanoBio Corporation Presents Preclinical And Interim Clinical Data On Topical Treatments For Herpes Labialis And Onychomycosis At AAD 2008 - articole medicale engleza - startsanatate