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, today announced NeutroPhase Skin and Wound Cleanser in combination with negative pressure wound therapy (NPWT) is featured in a case study as a new therapeutic technique for the management of necrotizing fasciitis. The case study titled, “Treatment of Acute Necrotizing Fasciitis Using Adjunctive Pure Hypochlorous Acid,” was presented at the 2012 Fall Symposium on Advanced Wound Care (SAWC), in Baltimore, Md.
Necrotizing fasciitis, also known as flesh eating bacteria, is most commonly caused by the group A streptococcus bacteria. The bacteria itself can be cleared with aggressive course of intravenous antibiotic therapy; however, the toxins secreted by the bacteria are known to destroy soft tissue at the subcutaneous level, causing toxic shock and in some cases death. Because of this, current standard of care for necrotizing fasciitis also involves an aggressive surgical debridement of necrotic tissue, which often leads to multiple amputations.
“The successful outcome of this particular patient case is exciting because it has lead us to the possible discovery of a new treatment protocol that could preempt the practice of debridement for the treatment of flesh eating bacterial infection,” stated, John Crew, MD, FACS, Medical Director, San Francisco Center for Advanced Wound Care at Seton Medical Center, San Francisco, Calif., and co-author of the study. “The new therapeutic technique combines aggressive wound irrigation with a unique pure hypochlorous acid solution known as NeutroPhase and negative pressure wound therapy, which lead to the full recovery of this patient. It is well known that hypochlorous acid has potent in-vitro activity against Strep A bacteria and more importantly has been shown in laboratory studies that it has the ability to neutralize toxins and superantigens produced by the group A streptococcus.”
NeutroPhase is an advanced wound cleanser developed by NovaBay Pharmaceuticals that contains 0.01% pure hypochlorous acid (HOCl), which has been proven to rapidly kill bacteria in solution. Pure HOCI has been reported to be 80-100 times more potent than sodium hypochlorite (commonly known as diluted bleach or Dakin’s solution).
The presented case study also includes a step-by-step treatment protocol to educate other wound specialists on how to perform the novel therapeutic technique, as well as a detailed look at the events that occurred concerning this particular patient, including initial incision and drainage, treatment with NeutroPhase and NPWT, length of hospital stay, prescribed home treatment regimen, and complete healing time.
The FDA has cleared NeutroPhase Skin and Wound Cleanserfor the cleansing and removal of foreign material including microorganisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. To date the FDA has not cleared NeutroPhase for the treatment of necrotizing fasciitis.
About NovaBay Pharmaceuticals, Inc.(www.novabaypharma.com)
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.
Cautionary Information Regarding 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)
Hui YH (ed.), 2006. Handbook of Food Science, Technology, And Engineering, Vol. 4. p. 193-24. CRC Press, Boca Raton, FL.