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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

herpes viruses, yeasts and fungi. In addition, in Phase I human studies, NVC-422 has been shown to be safe and well-tolerated in the nose and bladder. Also, a Phase I trial with NVC-422 for the treatment of eye infections has commenced under the auspices of NovaBay partner Alcon, Inc. (NYSE: ACL).

Preclinical Study Details and Results

The purpose of the current study was to identify the optimal dosage and delivery of NVC-422 for treating Trichophyton mentagrophytes dermatophyte based on an established animal model previously used in the preclinical evaluation of terbinafine (Lamisil(R)) and itraconazole (Sporanox(R)). Guinea pigs were randomized to either placebo or doses of NVC-422 of 0.5%, 1.0%, 1.5%, or 2.0% applied to infected skin three times a day for seven days. Evaluation of clinical and mycological efficacies was performed three days after completion of treatment. Skin biopsies were performed for analysis.

Clinical efficacy rates of NVC-422 ranged from 23.7% for the lowest dose to 36.6% for the highest dose compared to 3.6% for placebo. Mycological efficacy rates ranged from 86.0% for the lowest dose to 97.9% for the highest dose compared to 53.8% for placebo. Furthermore, when compared to a previous clinical study, high dose NVC-422 showed superior clinical and mycological efficacy rates in this animal model compared to ciclopirox (Penlac(R)), a well-established topical antifungal agent (36.6% and 97.9% versus 7.2% and 85.0%, respectively).

About NovaBay Pharmaceuticals, Inc.

NovaBay Pharmaceuticals is a mid-stage biopharmaceutical company developing first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells to treat and prevent a wide range of infections wi
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SOURCE NovaBay Pharmaceuticals, Inc.
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