ANN ARBOR – NanoBio Corporation reported

top-level findings Monday from its phase 2b study of NB-001, a topical

lotion to treat herpes labialis (cold sores). The randomized, double-blind,

vehicle- controlled study met its primary and secondary endpoints by

demonstrating clear efficacy and safety in 482 patients.

NanoBio’s lotion resulted in faster healing of cold

sores, at a rate never seen before by a topical product. The company’s

targeted phase 3 dose demonstrated highly statistically significant

clinical efficacy in phase 2b at a magnitude comparable with or superior to

what has been reported for the leading oral (systemic) anti-herpetic drugs

on the market today.

Additionally, NB-001 demonstrated an excellent safety profile, with no

serious adverse events, significant skin irritation or systemic blood

absorption. In contrast, leading oral systemic treatments for herpes

labialis carry label warnings that include nausea, diarrhea, vomiting, rash

and migraine.

“Through this trial, we have confirmed that NB-001 achieves the

efficacy of leading systemic treatments without presenting safety, drug

interaction or toxicity risks,” said James R. Baker Jr., MD, founder and

chairman of NanoBio Corporation. “Based on the data, NanoBio will move

immediately to initiate plans to begin phase 3 testing of NB-001 in early

2009.” The full data set from the phase 2b study will be presented

following a standard peer review process.

NB-001 is a proprietary oil-in-water emulsion composed of

nanometer-sized droplets that employ a physical process to disrupt the

outer lipid membrane of viruses. The droplets traverse the pores and hair

follicles of the skin without disrupting normal tissues. These droplets

accumulate in the epidermis and dermis where they interact directly with

and kill the viral organisms at the site of infection.

“The product’s novel mechanism leaves little risk of drug resistance,

which is a concern with the systemic antiviral therapies used to treat

herpes labialis,” said Baker. “This attribute coupled with its safety

profile may eventually allow NB-001 to be sold without a prescription. This

will be important to those people affected by this disease, since the vast

majority of herpes labialis sufferers today seek over-the-counter

treatments for their cold sores.”

a>>