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NovaBay Pharmaceuticals Announces Lead Anti-infective Product Candidate, NVC-422, Shown to be Effective in Treating Topical Fungal Infection
Date:3/7/2009

upport for continuing to develop NVC-422 for fungal infections."

NVC-422 is the most advanced of a series of compounds from a new class of drugs that mimics the body's natural defense against infection. NVC-422 may deliver the same or better efficacy as currently used antibiotics without contributing to the growing rise of bacterial resistance. The Company plans to file an exploratory Investigational New Drug application with the U.S. Food and Drug Administration in the second quarter of 2009 and initiate a Phase II clinical trial of NVC-422 during the second half of 2009 for impetigo, one of the most common skin infections among children, which produces blisters or sores on the face, neck, hands and diaper area.

"The ability to treat infection with a non-antibiotic is more important than ever because of the rise of drug resistant bacteria," said Dr. Ron Najafi, chairman and chief executive officer of NovaBay. "In developing anti-infective compounds, experience shows that preclinical results are more predictive of clinical efficacy than in other therapeutic categories, and I am encouraged that our preclinical work to date strongly suggests that NVC-422 may be a potent and well-tolerated treatment for numerous serious skin infections such as acne, nail fungus and topical viral infections, where antibiotics are not effective. Advancing NVC-422 into Phase II clinical trials reinforces the strength of our extensive preclinical work and, significantly, redefines NovaBay as a mid-stage biotech company."

NovaBay's experienced researchers have created a pipeline and research and development engine of first-in-class, broad-spectrum anti-bacterial and anti-fungal agents with low to no microbial resistance. In-vitro studies to date have shown that NVC-422 has a potentially expansive therapeutic utility against bacteria of all types, including multidrug resistant species; shedding viruses including adenoviruses; and
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SOURCE NovaBay Pharmaceuticals, Inc.
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