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| |  NB-001 0.3% Topical Nanoemulsion Benefits Herpes Patients: Presented at AAD By Jill Stein SAN FRANCISCO -- March 10, 2009 -- NB-001 0.3% accelerates the time to healing of cold sores in patients with recurrent herpes labialis compared with a vehicle cream, according to research presented here at the American Academy of Dermatology (AAD) 67th Annual Meeting. NB-001 is a topically applied, oil-in-water emulsion containing high-energy nanometre-sized droplets that permeate to the site of infection and kill the virus on contact. Terry Jones, MD, J & S Studies, Inc., College Station, Texas, and colleagues tested the efficacy of 3 concentrations of NB-001 (0.1%, 0.3%, and 0.5%) compared with vehicle in 919 patients with recurrent herpes labialis. They presented the study's findings on March 7. Currently available topical agents for herpes labialis are only marginally effective and oral therapies have raised concerns over the development of drug-resistant viral strains, according to the investigators. Participants in the trial received locked medication kits containing 1 of the 3 concentrations of NB-001 or vehicle. At the first sign of recurrence, subjects received an unlock code and started applying 200 mcL 5 times daily for a maximum of 4 days. Baseline demographic parameters were similar in the treatment groups and all treatments were well tolerated with no safety concerns or systemic absorption. Overall, 482 patients had a herpes labialis recurrence and started treatment. These patients constituted the intent-to-treat population. Investigator-assessed time to healing showed a highly significant improvement (P = .006) for subjects treated with NB-001 0.3% compared with vehicle, which was consistent with the permeation data in human cadaver skin and indicated that the 0.3% dosage form gives the highest tissue levels of NB-001. The researchers said that the treatment effect was higher than that reported for the current topical therapies and equal to that reported for high-dose oral nucleoside regimens. A subset analysis of subjects considered at the prodrome or erythaema stage at baseline indicated a mean time to healing of 3.6 days for subjects treated with NB-001 0.3%, which represents nearly 2 days of improvement over vehicle. Treatment was well tolerated without safety or toxicity concerns. The authors said that NB-001's novel physical mechanism of action "renders the emergence of drug resistance highly unlikely, making NB-001 an ideal candidate for widespread treatment of common conditions such as herpes labialis." Funding for the study was provided by NanoBio Corporation. [Presentation title: Investigator-Assessed Time to Healing in a Randomized, Double-Blind, Vehicle-Controlled Trial of a Novel Topical Antiviral Nanoemulsion (NB-001) for Recurrent Herpes Labialis. Abstract P2505]
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