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)/46th annual Infectious Diseases Society of
America (IDSA) 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.
About NanoBio
NanoBio(R) Corp. 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), acne and a broad platform of mucosal
vaccines. The company's headquarters and laboratory facilities are located
in Ann Arbor, Mich.
NanoBio Corporation
NanoBio