NovaBay Pharmaceuticals, Inc. (NYSE AMEX:NBY), a biotech company developing novel anti-infective products for the treatment and prevention of microbial infections, today announced its pure hypochlorous acid (HOCl) wound cleanser, NeutroPhase(R) , in combination with commercially available wound dressings, has been found to support healing when treating chronic non-healing wounds in three new patient case studies. The studies were presented in a poster at the 2012 Spring Symposium on Advanced Wound Care (SAWC) in conjunction with the 22nd Annual Meeting of the Wound Healing Society, in Atlanta, Ga.
John Crew, MD, FACS, vascular surgeon and medical director, San Francisco Center for Advanced Wound Care, Seton Medical Center, stated, “Natural wound healing can be impaired by a number of factors, including bacterial biofilm and infection. NeutroPhase is an FDA-cleared wound cleanser with a proven ability to disrupt biofilm and kill common wound pathogens, including P. aeruginosa, E. coli, S. aureus, C. albiconsand A. nigerin solution. These clinical case studies further demonstrate the importance of NeutroPhase as an irrigation solution to support healing for chronic non-healing wounds. They also highlight the simplicity and convenience of twice-daily NeutroPhase irrigation during negative pressure wound therapy.”
The poster titled, “Conquering Chronic Non-Healing Wounds with Pure Hypochlorous Acid,” presented by Dr. Crew, featured three patient case studies that showed NeutroPhase used as an irrigation solution to be efficacious in a patient with a chronic foot ulcer, cellulitis of the left thigh with confirmed MRSA, and with streptococcal cellulitis and fasciitis of the arm.
In addition, the poster compared the antibacterial activity of NeutroPhase to Microcyn(R)2 in an in vitro “zone of inhibition” bacterial killing assay. In this assay, NeutroPhase showed greater activity against S. aureus ATCC 29213 than Microcyn, exhibiting a larger “kill zone” after just one 15-minute treatment.
Russell Hoon, Vice President, Advanced Wound Care at NovaBay, and Roy J. Wu, Senior Vice President, Business Development, will be available throughout the Symposium to discuss potential partnerships and commercial opportunities for NeutroPhase(R). They will be present at NovaBay’s Booth #842. Please contact Mr. Wu at BusDev@novabaypharma.com to arrange prospective meetings.
1 Sorbact(R), Abigo Medical AB, Askim, Sweden
2 Microcyn(R), Oculus Innovative Sciences, Petaluma, CA
NeutroPhase is an FDA-cleared wound cleanser that consists of a solution of pure hypochlorous acid (HOCl), which mimics the compounds produced naturally by white blood cells to combat infection in the body. In numerous laboratory and clinical studies, NeutroPhase was proven to disrupt bacterial biofilm and kill common wound pathogens in solution (both Gram-positive and Gram-negative), while leaving healthy living human cells unharmed. Furthermore, the characteristics and mechanisms of action of NeutroPhase also make it highly unlikely that resistant strains of bacteria could develop over time. In a 54 patient double blind clinical study conducted at San Francisco Wound Care Center of Seton Medical Center, NeutroPhase was shown to be superior when compared with wet to moist saline dressing (standard of care) in patients with diabetic ulcers, venous ulcers and bedsores. Learn more about NeutroPhase at: www.neutrophase.com
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. The Company expects to launch a global Phase 2b clinical study in this indication in the second quarter of 2012.
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 in the third quarter of 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.novabaypharma.com
Forward Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. Statements regarding NovaBay’s expectations including, but not limited to, (i) any potential plans for future clinical development of its Aganocide compounds and of bringing products to market including the expected timing of the initiation of the Phase 2b impetigo clinical trial and Phase 2 conjunctivitis trial and expected timing of the results of the Phase 2, Part B UCBE trial; (ii) the potential efficacy of Aganocide&Neutrophase compounds (iii) NeutroPhase potential to treat the 6 million patients suffering from diabetic, pressure, and venous stasis ulcers; (iv) the development and potential benefits of, and the market opportunities for, NovaBay’s product candidates (v) the potential to deliver the same or better efficacy than antibiotics and to address the growing problem of antibiotic resistance as well as other statements that relate to future events or results, are forward-looking. 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: the risk that negative results from the development programs could preclude Galderma from providing additional funding to NovaBay; inherent risks and uncertainties relating to difficulties or delays in conducting clinical trials; the inherent uncertainty of patent protection for the company’s intellectual property or trade secrets, risks and uncertainties relating to difficulties or delays in discovery, development, testing, production and marketing of the company’s product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates; the company’s ability to obtain additional financing as necessary; and the risk of unexpected delays in the regulatory process which may delay the commencement or completion of clinical trials. 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 Annual Report on Form 10-K for the period ended December 31, 2011, under the caption “Risk Factors” in Item 1A of Part I of that report, filed with the Securities and Exchange Commission on March 27, 2012. 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
Contact Roy Wu
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson
Investors and Media:
The Ruth Group
Joshua Drumm, PhD (Investors)
Victora Aguiar (Media)
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