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www.LifeTechCapital.com December 7, 2010 Poster # and Title: #1239 “A Pilot Study to Evaluate the Safety and Efficacy of NVC-422 Topical Gel in Impetigo, Including MRSA” Author(s): Susan M. Iovino, BS, MT(ASCP) 1 , Kenneth D. Krantz, MD, PhD 1 , Daisy M. Blanco, MD 2 , Josefina Fernandez 3 , MD, Naomi F. Ocampo 1 , Azar Najafi, Bahram Memarzadeh, PhD 1 1 NovaBay Pharmaceuticals, Inc., Emeryville, CA, 2 Instituto Dermatologico, Santo Domingo, Dominican Republic, 3 Infectious Diseases Department, Robert Reid Cabral Children's Hospital, Santo Domingo, Dominican Republic Background: Impetigo is a highly contagious superficial bacterial infection of the skin that affects mostly children. Most cases are caused by Staphylococcus aureus, Streptococcus pyogenes, or a mixture of both organisms. Methicillin-resistant S. aureus (MRSA) is being observed with increasing frequency in this population. Impetigo is currently being treated with antibiotic ointments, to which bacteria may develop resistance. NVC-422 (N,N-dichloro-2,2-dimethyltaurine) is a non-antibiotic antimicrobial agent with potent activity against viruses, yeasts, fungi, and bacteria. NVC-422 was delivered in a polymeric gel that was used to evaluate safety and clinical efficacy in treating impetigo in pediatric patients in a pilot study. Methods: Children aged 2 - 12 years with primary non-bullous impetigo were randomized after written informed consent by their parent or guardian. This dose-ranging parallel group study tested 3 different treatments in an effort to determine the therapeutic dose for further study: a low, medium, and high dose. Sixty subjects were randomized in each dose group in 2 phases of the study. Treatment was administered 3x daily for 7 days to all randomized subjects. Response was measured by the Skin Infection Rating Scale (SIRS) and microbiological eradication. Results: A total of 129 patients were randomized. Clinical and microbiological success was seen in approximately 80% of all evaluable subjects after completion of treatment, and at follow-up one week later. The majority of the infections were S. aureus, with approximately 10% of those being MRSA, which responded at the same rate as non-MRSA infections. About 13% of the infections were mixed infections or S. pyogenes alone. Less than 5% of subjects had a treatment emergent transient adverse event with a possible causal relationship to treatment. Conclusions: Based on the results of this study, NVC-422 is a potentially useful novel, non-antibiotic, antimicrobial drug for the treatment of impetigo and further studies are warranted. Poster # and Title: #668 “In Vitro Evaluation of the Antifungal Activity of NVC-422 (N,N-dichloro-2,2-dimethyltaurine) Using a Novel Cadaver Nail Model” Author(s): Sarah A. Ibrahim, PhD 1 , Dmitri Debabov, PhD 1 , Mahmoud Ghannoum, PhD 2 , Mark Anderson, PhD 1 , Bahram Memarzadeh, PhD 1 1 NovaBay Pharmaceuticals, Inc., Emeryville, CA, 2 University Hospital Cleveland, Case West RU, Cleveland, OH Background: Onychomycosis is the most commonly diagnosed nail disorder. Topical treatment of the infection is limited by the inability of currently available drugs to penetrate the human nail. NVC-422 is a hydrophilic agent with potent antimicrobial activity making it a potential candidate as an effective ungal antifungal. In this study, a novel in vitro infected human nail model was developed and used to evaluate the ability of novel NVC-422 gel formulations and nanoemulsion lacquers to penetrate and kill fungi grown on the subungal side. Methods: T. mentagrophytes and T. rubrum were used to inoculate the ventral surface of the cadaver nails and incubated for one week at 30°C. To ensure adequate infection of the nail, scrapings were stained with calcofluor white and examined microscopically for the presence of hyphae. Infected nails were then treated with a single application of test NVC-422 formulations pipetted onto the dorsal surface of the nail, and incubated for another week. Next, nails were cleaned with solvent to remove the applied formulations; ground and fungal viability determined as colony forming units (CFUs). 8% Ciclopirox lacquer was used as a comparator. Results: Our data showed that NVC-422 was able to penetrate the nail and effectively eradicate T. mentagrophytes and T. rubrum. The antifungal activities of the test formulations were evaluated based on: a) number of CFUs, and b) visual NovaBay Pharmaceuticals (NBY) Page 18
www.LifeTechCapital.com December 7, 2010 fungal growth on nails. The novel gel formulations and nanoemulsion lacquers demonstrated significant nail penetration and antifungal activity following nail penetration indicated by no visual growth and a significant reduction in the CFUs. Conclusions: In this study we developed and evaluated a novel infected human cadaver nail model and used it to assess the penetration and activity of selected formulations. Our data showed that NVC-422 gel and nanoemulsion lacquer formulations, were able to penetrate the nail and eradicate the two most common fungal species causing onychomycosis. Further evaluation of NVC-422 is warranted. ICAAC: NovaBay presented 4 posters on their Aganocide ® compounds at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) September 12-15, 2010 in Boston. Poster # and Title: V-420/444 -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 Author(s): J. STRÖHLE 1 , M. NAGL 1 , D. DEBABOV 2 , K. HYBISKE 3 , M. ANDERSON 2 1 Innsbruck Med. Univ., Innsbruck, Austria, 2 NovaBay Pharmaceuticals, Inc., Emeryville, CA, 3 NovaBay Pharmaceuticals, Inc., Emeryville, CA. Background: This study aimed to evaluate the in vitro activity of N-chlorotaurine, an endogenous chloramine compound produced by human phagocytes. Analogs N-monochloro-2-2-dimethyltaurine (NVC-612) and N,N-dichloro-2,2dimethyltaurine (NVC-422) were tested for their in vitro virucidal activity against influenza A. Methods: Influenza H1N1 (Singapore / Hong Kong 2339, 2000; H. Katinger, Vienna), H1N1 (APR-8-38, MicroTest) and H1N1v (California, 2009; clinical isolate, Innsbruck) were grown on MDCK or Vero cells in RPMI 1640. Cell-free supernatants containing 106 to 109 plaque forming units (pfu)/ml were incubated at room temperature in solutions of test substances at different concentrations and times. After inactivation of the oxidants with sodium thiosulfate or serum-free medium, aliquots were transferred to monolayers of MDCK or Vero cells in serial ten-fold dilutions. Cells were incubated and monitored for 7-10 days for cytopathic effects. Results: All three test substances inactivated all viral strains, while the controls with taurine and dimethyltaurine did not result in reduction of pfu/ml. NCT and NVC-612 (5.5 mM in water) inactivated H1N1 Singapore to the detection limit after 5 min incubation time (reduction factor > 5 log10), while pfu/ml of H1N1v were reduced by approximately 2 log10 after 5 min and 4 log10 after 10 min. Both strains were inactivated to the detection limit by 55 mM NCT and NVC-612 within 1 min. A 10 min incubation with 10 and 30 mM NVC-422 in water at pH7 reduced the titer of H1N1v by 1 and 2 log 10, respectively. 1 hr treatment with 40 mM NVC-422 in saline pH 4 resulted in 4 log10 reduction. Conclusions: NCT, NVC-612, and NVC-422 all demonstrated virucidal activity against influenza A. The in vitro data suggest that H1N1 (Singapore 2000) was slightly more susceptible than H1N1v (California 2009). Poster # and Title: K-2199/220 Efficacy of NVC-422, a Novel Derivative of N-Chlorotaurine, in Controlling Crystalline Proteus mirabilis Biofilm Formation on Urinary Catheters Author(s): S. ABDUL RANI, C. CELERI, D. DEBABOV, M. ANDERSON, R. NAJAFI; NovaBay Pharmaceuticals, Emeryville, CA. Abstract: Background: Infection by Proteus mirabilis can complicate patient care with long-term indwelling bladder catheters. These urease-producing bacilli elevate urinary pH, colonize catheters and produce crystalline biofilms that can block the flow of urine from the bladder. NovaBay has developed a non-antibiotic, anti-infective compound (NVC-422; N,Ndichloro-2,2-dimethyltaurine), a stable derivative of the natural antimicrobial N-chlorotaurine that exhibits potent broad spectrum antimicrobial activity with an excellent safety profile. Here we investigated the potential use of NVC-422 in an instillation solution for the control of catheter blockage by P. mirabilis biofilm. Methods: Experiments were performed in laboratory models of the catheterized bladder fed artificial urine and inoculated with P. mirabilis. NVC-422 or saline was installed daily into the catheterized bladder chambers following protocols to simulate clinical bladder washout regimens. The experiments were run for 144h or until catheters blocked. The pH of the NovaBay Pharmaceuticals (NBY) Page 19
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