NovaBay® Pharmaceuticals, Inc. (NYSE Alternext: NBY), a clinical stage biopharmaceutical company, today announced that new preclinical data related to NVC-422, the lead molecule in NovaBay’s, proprietary Aganocide® class of compounds, will be presented at the American Academy of Dermatology (AAD) 67th Annual Meeting in San Francisco during March 6-10, 2009. NovaBay® is focused on developing first-in-class, novel, synthetic anti-infective product candidates that are bioequivalent to the active antimicrobial molecules generated within white blood cells for the treatment and prevention of bacterial, fungal, and viral infections without developing resistance.
“We have new data at the upcoming AAD annual meeting that further demonstrate the potential of NVC-422 and our Aganocide® class of compounds to effectively treat chronic and common fungal skin infections,” said Dr. Ron Najafi, chairman and chief executive officer. “Data from the Center for Medical Mycology at Case Western Reserve University Hospitals confirm how our novel, anti-infective agent in an animal model is highly effective not only on the skin surface, but also showed potent ability to kill subcutaneous organisms by route of the hair follicles.”
Following are the details on the poster presentation.
Saturday, March 7
Poster Title: “Efficacy of NVC 422 in the Topical Treatment of Dermatophytosis in a Guinea Pig Model”
Professor Mahmoud Ghannoum et al
Time: 9:20 a.m. Pacific Time
Moscone Center North, Hall E, Abstract #2405
NVC-422 is the lead molecule in NovaBay’s Aganocide® class of compounds. NVC-422 is a non-antibiotic, stable analog of an anti-infective molecule produced by white blood cells. NovaBay® believes that NVC-422 may deliver the same or better efficacy as currently used antibiotics without giving rise to resistant bacteria. In past in-vitro studies, NVC-422 has shown a broad therapeutic index with broad spectrum activity against bacteria of all types, including multidrug resistant species, shedding viruses including adenoviruses and herpes viruses, yeasts and fungi. In addition, NVC-422 has previously shown, in-vivo, to be safe at expected therapeutic doses in the nose, bladder, wounds and eye. NVC-422 is protected by U.S. Patent #7,462,361 until 2026. In addition to Alcon’s development in the eye, NovaBay® has taken NVC-422 into Phase II human trials for infections in the nose and bladder and expects to begin a Phase II trial for the treatment of skin infections, including those caused by MRSA (Methicillin resistant Staphylococcus aureus), in 2009.
About NovaBay® Pharmaceuticals, Inc.
NovaBay® Pharmaceuticals is a clinical 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 without developing resistance. NovaBay® has entered into a licensing and research collaboration agreement with Alcon, Inc. for use of the Aganocide® compounds in the eye, ear and sinus, and in contact lens solutions. NovaBay® and Aganocide® are trademarks of NovaBay® Pharmaceuticals, Inc. For more information on NovaBay, visit www. novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
The statements in this press release regarding the potential efficacy of NVC-422 and NovaBay’s expectation to begin a Phase II trial for the treatment of skin infections in 2009 are forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the risk that results obtained in animal models may not be obtained in humans, and the risk of unexpected delays in the regulatory process may delay the commencement or completion of clinical trials. Other risks relating to NovaBay® and NVC-422, including risks that could cause actual results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s Quarterly Report on Form 10-Q/A for the period ended September 30, 2008, under the caption “Risk Factors” in Item 1A of Part II of that report, which was filed with the Securities and Exchange Commission on November 14, 2008.
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson
Gregory Gin, 908-376-7737
Mariesa Kemble, 608-850-4745