Feb 4 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.