AgaDerm™ Formulation Shown To Be Effective In Established Antifungal Model

NovaBay Pharmaceuticals, Inc. (AMEX: NBY) a clinical stage biopharmaceutical company, gave more details today on its dermatology program. Dr. Ron Najafi, Chairman and CEO, said that “NovaBay is now accelerating its efforts in dermatology. We formed our DermaBay subsidiary in 2007, to build up our expertise and move forward in dermatology. Our Aganocide® compounds have appeared all along to be of significant potential interest in dermatology, but we needed to deliver the compounds in acceptable dermatological formulations. We now have the necessary capabilities to proceed with product development in dermatology.”

Dr. Eric Memarzadeh, Senior Director, Pharmaceutical Development, explained that as a result of work done over the last year, NovaBay has succeeded in developing several pharmaceutical formulations of Aganocide compounds for use in its programs, including some that are specifically designed for use in dermatology. One formulation, known as AgaDerm™, had been tested in a challenging animal model of dermatophyte infection. The AgaDerm formulation delivered an Aganocide compound effectively when applied on the surface of the skin and enhanced its penetration into hair follicles. The infectious agent was a dermatophyte, Trichophyton mentagrophytes, a parasitic fungus that causes infections of the nails, hair and skin, including ringworm. The Aganocide compound in the AgaDerm formulation was shown to be highly effective not only on the skin surface, but also showed potent ability to kill organisms invading the hair. It was equal or greater in antifungal efficacy to ciclopirox 8% (Sanofi-Aventis, Penlac®), a standard and well established topical antifungal agent that is also sold as a 0.77% gel and as a 1% shampoo by Medicis (Loprox®).

Colin Scott, M.D., Vice-President of Clinical Research and Development, explained that NovaBay was now optimizing the concentration to be used for clinical studies. He said that NovaBay will complete the necessary IND-enabling toxicology studies before beginning a Phase I study. He added that other NovaBay Phase I studies in humans had already demonstrated the safety in humans of the compound in nasal passages and in the bladder.

Dr. Najafi said that he was very satisfied with the way that the program was proceeding and that he has appointed Jack O’Reilly as General Manager of DermaBay to manage the company’s strategic development in dermatology.

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