NovaBay Pharmaceuticals, Inc. (NYSE Amex: NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, delivered four poster presentations on its Aganocide compounds at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, MA.
The presentations included new data from studies of NovaBay’s Aganocide compounds, which indicated that NovaBay’s Aganocide compounds are highly effective against bacteria, including some multi-drug resistant strains (such as MRSA), viruses and fungi in preclinical testing.
Dr. Ron Najafi, chairman and CEO of NovaBay, said, “These presentations clearly illustrated the potency and versatility of our lead Aganocide compounds that are currently in four Phase 2 human trials. In our 1st poster we demonstrated their ability to inhibit harmful bacteria in biofilm inside urinary catheters; our 2nd poster confirmed their dual antimicrobial/anticoagulant properties; in our 3rd poster we displayed antiviral activity against the H1N1 influenza virus in cell culture studies; and in our 4th poster our research indicated that these compounds are effective in killing pathogens such as P. aeruginosa and S. aureus without harming dermal and ocular tissues.”
NovaBay’s pipeline of Aganocide compounds is being studied in numerous preclinical programs and is currently in four Phase 2 clinical trials, including for: impetigo, a highly contagious skin infection; urinary catheter bacterial biofilm blockage, encrustation and associated infection; conjunctivitis, or pink eye infection; and acne.
The posters and their conclusions were as follows:
Efficacy of NVC-422, a Novel Derivative of N-Chlorotaurine, in Controlling Crystalline Proteus mirabilis
Biofilm Formation on Urinary Catheters:
Dr. Dmitri Debabov et al. investigated the potential use of NVC-422 as an irrigation solution to resolve catheter biofilm blockage and encrustation caused by P. mirabilis, a Gram-negative bacterium. Results indicated that a 0.2% irrigation solution of NVC-422 kept a urinary Foley catheter unblocked for 144 hours and no biofilm was apparent. The researchers concluded that a bladder irrigation solution using NVC-422 could manage catheter biofilm blockage and encrustation if used on a regular basis. Based on this report and NovaBay’s previously reported successful Phase 1 and 2a human trials, an expanded Phase 2b trial is planned for this unmet medical need affecting paraplegic, quadriplegic, stroke, and multiple sclerosis patients.
Anticoagulant Effects of N-Chlorotaurine and the Analogs N-Monochloro-2,2-Dimethyltaurine and N,N-Dichloro-2,2-Dimethyltaurine:
Professor Markus Nagl, MD et al. evaluated the effect of NCT, NVC-612 and NVC-422 on blood coagulation pathways. The aim was to evaluate the compounds’ potential roles as anticoagulants, which, in addition to their known antimicrobial activity, would make them candidates for catheter lock solutions. At the evaluated concentrations, the compounds exhibited both antimicrobial and anticoagulant properties. Further investigation into this novel anticoagulant property is underway at NovaBay and the Medical University of Innsbruck in Austria to develop potential therapeutic applications.
In Vitro Activity of N-Chlorotaurine (NCT), N-Monochloro-2,2-Dimethyltaurine (NVC-612) and N,N-Dichloro-2,2-Dimethyltaurine (NVC-422) against Influenza Viruses:
Professor Markus Nagl, MD et al. evaluated the virucidal activity of NCT, NVC-612 and NVC-422 on three separate strains of influenza H1N1 also known as Swine Flu, (H1N1 Singapore, H1N1 California, and H1N1 Apr-8-38). The researchers determined that all three compounds exhibited a dose-dependent inhibition of H1N1 viral infectivity in a cell culture model. Further investigation into this antiviral activity and its potential therapeutic utility is underway at NovaBay and with its European collaborators at the Medical University of Innsbruck in Austria.
NVC-422: Towards Developing Preclinical Infected Tissue Models:
Dr. Dmitri Debabov et al. reported on two infected tissue models in human dermal and ocular epithelial cells. These models mimic the human infected tissue environment caused by P. aeruginosa and S. aureus. These models help to demonstrate the effect of an antimicrobial compound in a proprietary formulation regarding its activity and safety. NovaBay’s lead Aganocide, NVC-422 demonstrated good antimicrobial killing with no safety issues in these infected tissue models. Furthermore, these results reflect what has been observed in NovaBay’s human clinical trials.
NovaBay’s Aganocide® compounds are novel, synthetic N-chlorinated antimicrobial molecules specifically designed and developed to mimic the body’s natural defense against infection. The Aganocide compounds maintain biological activities while demonstrating improved stability over the naturally occurring N-chlorinated antimicrobial molecules. In preclinical testing, NovaBay’s Aganocide compounds have been shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA), viruses and fungi. NovaBay’s Aganocide compounds have the potential to deliver the same or better efficacy than antibiotics, and to address the growing problem of antibiotic resistance by employing a novel mechanism of action.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary and patented Aganocide compounds, which are novel, synthetic anti-infective product candidates with equivalent activity to the active antimicrobial molecules generated within white blood cells. NovaBay’s Aganocide compounds are being developed to treat and prevent a wide range of infections without causing bacterial resistance. NovaBay has internal development programs aimed at addressing hospital and respiratory infections. The company has a license and research collaboration agreement with Alcon, Inc. for use of its Aganocide compounds to treat eye, ear and sinus infections as well as for contact lens care. NovaBay has also entered into an agreement with Galderma S.A. to develop and commercialize Aganocide compounds in acne, impetigo and other dermatological indications. For more information on NovaBay, visitwww.novabaypharma.com
Cautionary Information Regarding Forward-Looking Statements
The statements in this press release of NovaBay’s expectations and the potential regarding its Aganocide compounds are forward-looking statements. Actual results may differ materially due to a number of risks and uncertainties, including: results in preclinical and other studies may differ from results obtained in clinical trials; unexpected results may be obtained in further studies due to the inherent uncertainty in the development of NovaBay’s compounds; and the inherent uncertainty of obtaining regulatory approvals may prevent NovaBay from being able to bring its potential products to market. Other risks relating to NovaBay and its 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 Quarterly Report on Form 10-Q for the period ended June 30, 2010, under the caption “Risk Factors” in Item 1A of Part II of that report, filed with the Securities and Exchange Commission on August 12, 2010. 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 Pharmaceuticals Contacts
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