NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY): In the latest issue of the journal Cell, scientists at the Hebrew University of Jerusalem’s Faculty of Medicine showed that Streptococcus pyogenes, an ordinarily benign to mildly infectious bacteria, sometimes begins to produce bacterial toxins when it gets under the skin. Those toxins, in turn, cause a defensive stress response in neighboring human cells that triggers the bacteria to ramp up toxin production. Those toxins then rapidly destroy tissue and threaten the lives of patients. As many as 25% of victims die, even after being treated with antibiotics—adding up to an estimated 500,000 deaths and severe injuries worldwide each year, according to the Hebrew University of Jerusalem researchers. Many more victims may require amputations of an arm or a leg to save their lives.
The new research shows the importance of treating patients not just by fighting the bacteria, but also by neutralizing the bacterial toxins they produce. “Flesh-eating disease needs to be managed aggressively by attacking both the bacteria and their toxins, as a part of comprehensive procedure to potentially decrease mortality and the chance of amputation in patients,” said Ron Najafi, Ph.D., Chief Executive Officer of NovaBay.
That’s where NovaBay’s existing product and technology platform could play a role. In a study in a recent issue of the journal Wounds, John Crew, MD, FACS, Vascular Surgeon, Medical Director, Advanced Wound Care Center, Seton Medical Center in Daly City, California, and the NovaBay research team reported that in laboratory experiments, NeutroPhase® has a potent ability to neutralize deadly bacterial toxins. In that paper, Dr. Crew also reported that his use of NeutroPhase, in combination with negative pressure wound therapy, resulted in saving the life of a patient with necrotizing fasciitis, which is one type of flesh-eating disease.
In an additional paper now in press, Dr. Crew will report on seven additional cases of flesh-eating disease. Using NeutroPhase as part of the treatment program for those patients, Dr. Crew was able to save not only their lives, but also their limbs, as none of those patients required amputations.
NeutroPhase is a pure, stable version of hypochlorous acid, a natural substance produced by the human immune system as a first defense against invading pathogens. The product has received regulatory clearances by the FDA as a skin and wound cleanser and for patients suffering with chronic stage I-IV pressure ulcers. In extensive laboratory studies, NeutroPhase has been shown to neutralize staphylococcal alpha toxin, streptococcal streptokinase and other potentially deadly toxins associated with flesh-eating bacteria.
“We believe NeutroPhase or other products currently in development by NovaBay are going to be a very important adjunct therapy for flesh-eating disease,” said Ron Najafi, Ph.D., Chief Executive Officer of the Company, adding, “The finding of the Hebrew University research team confirms the importance of bacterial toxins and the unique therapy developed by Dr. Crew.”
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on addressing the unmet therapeutic needs of the global, topical anti-infective market with its Aganocide compounds, led by auriclosene. Auriclosene is a new chemical entity invented by NovaBay that has a broad spectrum of activity against bacteria, viruses and fungi. Aganocide compounds are based on the human body’s natural immune system and the molecules involved in combating infections. Bacterial resistance to Aganocides is highly unlikely, as demonstrated in published studies. Once pathogens penetrate the body’s primary defense, the next line of defense is provided by the white blood cells. NovaBay has focused on understanding these molecules generated by the white blood cells and finding ways, by chemical modification, to allow them to be developed as therapeutic products with the potential to treat a wide range of local, non-systemic infections. NovaBay believes that Aganocides will help reduce the rise of antibiotic resistance as they begin to supplant the usage of classic topical antibiotics.
This release contains forward-looking statements and opinions, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the success of NovaBay products in the treatment of flesh-eating diseases. The words “could,” “potentially,” “believe,” “may,” and “will” are intended to identify these forward-looking statements. 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 latest 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.
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