Novabay Pharmaceuticals, Inc. (NYSE-AMEX: NBY, http//www.novabaypharma.com), a clinical stage company developing novel anti-infective compounds for the treatment or prevention of a wide range of bacterial, viral and fungal infections, presented in two poster sessions today at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. These two separate laboratory studies of its Aganocide® compounds reveal potent activity in killing bacteria that have developed resistance to antiseptics and antibiotics and that the compounds demonstrate rapid bactericidal and anti-biofilm activity in the presence of plasma, serum or albumin.
The two studies conducted by NovaBay scientists advance the company’s efforts to provide solutions to the global problem of multidrug-resistant bacteria, which are rapidly diminishing the effectiveness of antibiotics and antiseptics for the treatment and prevention of many common infections. While multi-drug resistance to antibiotics has received much attention over the past few years, resistance to antiseptics is becoming an increasing concern.
“Modern medicine faces an urgent need to develop new classes of drugs that do not develop resistance to antibiotics and antiseptics,” said Ron Najafi, president and CEO of NovaBay. “Our Aganocide compounds are an example of such a drug and they are on the bioequivalent of the natural anti-microbial compounds produced in white blood cells that have remained effective against invading pathogens for millions of years.”
The first study examined the bactericidal activity of NovaBay’s lead aganocide compound NVC-422 against antiseptic and antibiotic-resistant Staphylococcus aureus. Efflux pumps in bacterial cells are common mechanisms for resistance, and in S. aureus, the genes qacA/B, qacC and norA encode multidrug-transporter pumps. The genes have been previously identified as key to the development of antiseptic resistance.
The researchers compared the effectiveness of NVC-422 with chlorhexidine, pentamidine and proflavine against S. aureus strains that expressed the resistance genes. Measurements were made of the minimum inhibitory concentration (MIC), which is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation, and the minimum bactericidal concentration (MBC), which is the lowest concentration of antibiotic required to kill an organism. The subset of S. aureus clinical strains that tested positive for qacA/B were found to be resistant to chlorhexidine, pentamidine and proflavine, consistent with MIC values reported in the literature. But, these strains exhibited no resistance to NVC-422, with MBC values similar to the MBC value of a S. aureus antiseptic-sensitive strain.
In the second study, NovaBay scientists evaluated the effectiveness of the Aganocides NVC-422and NVC-612, as well as endogenous N-chlorotaurine (NCT) produced by white blood cells, against S. aureus, Escherichia coli and Candida albicans in the presence of human plasma, serum and albumin (HSA). NVC-422 was also tested against biofilm. Results showed that the Aganocide compounds were effective against the selected microbes, including biofilms.
“This second study is exciting because it shows effectiveness of the Aganocides within the critical environments found in the human body,” said Ron Najafi, president and CEO of NovaBay. “These compelling data further support our efforts in advancing our current clinical studies and moving other pre-clinical programs to human testing.”
About Aganocide® Compounds
The Aganocide® compounds are novel, proprietary, synthetic N-chlorinated antimicrobial molecules specifically developed by Novabay to mimic the body’s natural defense against infection. The Aganocide® compounds maintain the biological activities while improving the stability of naturally occurring N-chlorinated antimicrobial molecules. These highly differentiated, first-in-class, small-molecule, patented new chemical entities may be able to deliver the same or better efficacy than currently used antibiotics without contributing to the growing rise of antibiotic-resistant bacterial strains. In preclinical testing, the Aganocide® compounds have been shown to be highly effective against bacteria, including multi-drug resistant strains, viruses and fungi. They also have been demonstrated to be effective against bacteria in biofilms, which render most antibiotics ineffective. Aganocides have a broad therapeutic index while providing a high degree of potency and tolerability as well as dosing versatility and flexibility.
Novabay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing its proprietary and patented Aganocide® compounds, which are 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 causing bacterial resistance. Novabay has internal development programs aimed at addressing dermatological, hospital and respiratory infections. The company has a licensing and research collaboration agreement with Alcon, Inc. for use of its Aganocide® compounds to treat eye, ear and sinus infections as well as in contact lens care solutions. Novabay has also entered into an agreement with Galderma S.A. to develop and commercialize Aganocides in acne, impetigo and other dermatological indications. For more information on NovaBay, visit: www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
The statements in this press release of NovaBay’s expectations regarding the Aganocides possessing the characteristics of a broad spectrum antimicrobial agent that carries little potential for resistance and the development and commercialization of its Aganocide® compounds through collaborations with corporate partners and other risks relating to Novabay and its Aganocide® compounds, 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 Annual Report on Form 10-K, under the caption “Risk Factors” in Item 1A of Part I of that report, which was filed with the Securities and Exchange Commission on March 31, 2009.
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson