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The study of NVC-422, which is a synthetic bioequivalent form of the most effective and rapidly-acting anti-infective molecules produced by white blood cells, revealed significant clinical and mycological efficacy compared to the untreated control group at all doses evaluated, with the highest clinical and mycological efficacy rates of 36.6% (p <0.0001) and 97.9% (p <0.05), respectively, achieved in the highest dose group. These data confirm previous preclinical results that showed a high level of activity for high dose NVC-422 against dermatophytes. The results were presented at the American Academy of Dermatology (AAD) 67th Annual Meeting in San Francisco (Abstract #2405).
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"Dermatophytosis is a group of chronic and common skin infections that causes significant discomfort and cosmetic problems, and currently available drugs often do not provide adequate cure and cause unwanted side effects," said Mahmoud A. Ghannoum, Ph.D., Director of the Center for Medical Mycology, Department of Dermatology, University Hospitals of Cleveland, and Case Western Reserve University. "The significant clinical and mycological efficacy rates shown in this study demonstrate that topical NVC-422 penetrates the skin and hair at the infection site indicating that it has the potential to target and eliminate skin infections, including onychomycosis, tinea pedis, and tinea capitis. Importantly, these data provide strong support 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 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 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(R) and Aganocide(R) 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.
SOURCE NovaBay Pharmaceuticals, Inc.
