NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide® compounds for the local non-systemic treatment and prevention of infections, announces data supporting the mechanism of action for its lead Aganocide compound, NVC-422, against toxins secreted by bacteria such as Escherichia coli (E. coli). The data was presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, on September 12, 2012 in a poster that featured a collaborative study with the Innsbruck Medical University.
The poster, titled “N-chlorotaurine, a long-lived endogenous oxidant, inactivates Shiga toxin 2 (Stx2) of enterohemorrhagic E. coli” shows data from a study investigating the chemical impact of Aganocide compounds N-chlorotaurine (NCT), a long-lived oxidant produced by the activation of human white blood cells and known to exert broad-spectrum antimicrobial activity, and its novel analog with long-term solution stability, NVC-422, on Shiga toxin 2 (Stx2), a toxin secreted by E. coli. The study provided evidence that 5.5 mM of NCT or NVC-422 oxidizes and inactivates the toxin Stx2, therefore concluding that long-lived oxidants, such as NCT, may act as powerful tools of innate immunity against soluble toxins secreted by common bacteria.
Dmitri Debabov, Ph.D., Director of Cell Biology and Microbiology at NovaBay and co-author of the study, stated, “This study shows the chemical impact of Aganocides and proves their ability to neutralize bacterial toxins. With the discovery of NovaBay’s Aganocide NVC-422, we’ve identified a novel analog of NCT with a higher long-term solution stability, rapid antimicrobial activity and activity against bacterial toxins. Therefore, we believe this data provides further evidence that NVC-422 is capable of therapeutic success as a topical anti-infective.”
NVC-422 is a novel anti-infective with broad-spectrum bactericidal activity and novel mechanism of action to address the unmet medical needs in several large markets. The compound has been shown to be highly effective in vitro against multi-drug resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). Different topical formulations of NVC-422 are in mid-to-late-stage clinical development in ophthalmology, dermatology and urology.
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products.
NovaBay’s first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic molecules with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides possess a reduced likelihood that bacteria or viruses will be able to develop resistance, which is critical for advanced anti-infectives. Having demonstrated therapeutic proof-of-concept in three Phase 2 clinical studies, these compounds are suited to treat and prevent a wide range of local, non-systemic infections. NovaBay is currently concentrated on three large therapeutic markets:
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo. Current product offerings give rise to resistance. A major global clinical study is planned for 2012.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 for treating viral conjunctivitis, for which there is currently no FDA-approved treatment. Enrollment into a global Phase 2b clinical study has begun with top-line data expected in the first half of 2013.
Urology – NovaBay’s irrigation solution containing NVC-422 is currently in Phase 2 clinical studies, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from Part A of this study and expects to announce top-line results from Part B later in 2012.
NovaBay is also developing NeutroPhase, which is an FDA 510(k)-cleared product for advanced wound care. We believe that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the six-million-patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. For additional information, visit:www.neutrophase.com
Forward Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the expected timing of enrollment and commencement of clinical trials, expected timing of receipt and announcement of results of clinical studies, and efficacy of NeutroPhase and Aganocides. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company’s product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company’s intellectual property or trade secrets, the company’s ability to obtain additional financing as necessary and unanticipated research and development and other costs. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
NovaBay Business Development and Licensing:
Roy J. Wu
Sr. VP Business Development
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson
Investors and Media:
The Ruth Group
Nicole Greenbaum (Investors)
Victoria Aguiar (Media)