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news.NanoBio has started two Phase 3 trials to evaluate NB-001, indicated for the treatment of cold sores, under its OTC licensing pact with GlaxoSmithKline Consumer Healthcare (GSK CH) signed in December 2009.
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The company expects to recruit around 1700 patients to evaluate the effectiveness of NB-001 at 72 clinical sites.
The patient recruitment will be completed in 2012.
NanoBio Clinical Research vice president Mary Flack said based on the efficacy of NB-001 in Phase 2, they are very optimistic about these trials and the path to FDA approval.
"The initiation of these trials marks a significant step towards the commercialization of a new treatment offering for cold sores, as well as potential other new offerings to come from our nanoemulsion-based platform technology," Flack said.