WASHINGTON, D.C. (October 28, 2008) -- Scientists at NanoBio Corporation have demonstrated for the first time in humans that a novel topical treatment for cold sores (herpes labialis), NB-001, speeds healing of lesions as effectively as the leading oral systemic drugs but without safety or toxicity concerns.
The new data provide the first proof of principle that a topical agent can attain equivalent efficacy rates to oral systemic drugs, according to the NanoBio scientists. Topical treatments are widely considered inferior to oral systemic treatments because they fail to penetrate to the site of infection with adequate drug levels required to subdue infections.
In the study of 482 patients, NB-001 healed lesions 1.3 days faster than placebo as measured by investigators (P=0.006). Results of the randomized, double-blind, placebo-controlled, phase 2b trial are being presented 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.
NB-001 was well tolerated, without safety concerns or adverse events, and was not systemically absorbed. "NB-001 challenges the conventional wisdom that topical therapies are less effective, because NB-001 directly accesses the site of infection in the dermis and epidermis instead of remaining on top of the skin," said James R. Baker, Jr., M.D., founder and chairman of NanoBio Corp. "NB-001 employs a physical mode of action to disrupt the outer membranes of pathogens and prompt viral lysis, essentially killing on contact."
The study also suggests that the physical mode of action of NB-001 significantly reduces the likelihood that pathogens will develop resistance to the biocidal effect of the topical lotion.
"These characteristics make NB-001 an ideal candidate for first-line treatment with the potential for widespread use across a broad range of patients," said Mary Flack, M.D., vice president of clinical research at NanoBio and author of the oral presentation.
NanoBio scientists credit the topical lotion's safety and robust anti-infective activity to NB-001'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 skin or mucous membranes. Upon contact with the pathogen, the highly charged particles release their energy to the pathogen's outer membranes, disrupting the viral particle.
"The ability of NB-001 to penetrate skin pores and hair follicles is essential to its activity in the dermis and epidermis, where it surrounds and fuses with herpes simplex virus and disrupts the outer envelope of the pathogen," Flack said. "NB-001 does not compromise tissue integrity, so it is not absorbed into the bloodstream."
Because the herpes simplex virus causes both cold sores and genital herpes, there is a strong potential that NB-001 will also be effective in treating genital lesions, she added.
NanoBio is currently testing its pipeline of topical products against a wide range of skin infections including onychomycosis (nail fungus), tinea capititis (ringworm) and acne.
NanoBio® Corp. is a privately held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat™ technology platform. The company's lead product candidates are treatments for herpes labialis (cold sores), onychomycosis (nail fungus), acne and a broad platform of mucosal vaccines. The company's headquarters and laboratory facilities are located in Ann Arbor, Mich.