NanoBio Corporation, a biopharmaceutical company developing novel products for the treatment and prevention of topical infections, has begun enrolling patients in its phase 2b study of NB-001, a drug candidate for the topical treatment of herpes labialis. The phase 2b trial is a randomized, placebo-controlled study at 30 sites in the United States, where 1,000 potential subjects are being recruited.

"We are pleased to be able to move NB-001 into the next stage of clinical development," stated Dr. James Baker, NanoBio's Chairman of the Board and Chief Science Officer. "Given the remarkable safety profile of NB-001 and the clear efficacy demonstrated in our prior trial, we are now able to perform a Phase 2b study with doses that are three and five times higher then previously used."

Dr. Baker added, "NB-001 safely and effectively targets the Herpes virus when applied to the skin, thus making it a promising topical treatment for herpes labialis. Its novel mechanism of action leaves little risk of drug resistance, which is a concern with the systemic anti-viral therapies used to treat this disease. These attributes may eventually allow NB-001 to be sold without a prescription."

In 2005, NanoBio completed a Phase 2 study of NB-001 for the treatment of herpes labialis. The trial was a multi-centre, randomized, placebo-controlled study in the United States, involving 332 subjects. When compared to a placebo, a substantially higher proportion of subjects receiving NB-001 healed within three days (17% vs 2%, p=0.0046) or four days (25% vs. 10%, p=0.036). Also, the time it took for sores to heal in NB-001-treated subjects was shortened by over a day (6.26 days treated vs. 7.42 days untreated). No drug-related adverse events, no skin irritation, and no systemic absorption of NB-001 were observed.

Cold sores or fever blisters on the lips or surrounding skin are predominantly caused by the herpes simplex I (HSV1) virus. Approximately 80% of all Americans are infected with HSV1 and approximately 20% to 40% of adults suffer from recurrent outbreaks of cold sores. While not life-threatening, these attacks can be painful and unsightly, and are highly contagious. The global market for herpes labialis treatments is expected to grow to $1.7 billion annually when NB-001 is targeted to reach the market in 2010-2011.

NanoBio Corporation 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 for the treatment of Herpes labialis (cold sores) and onychomycosis (nail fungus) are in clinical trials.