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NovaBay Announces Positive Phase I Study Results with Its Lead Aganocide Compound
Product Shown to be Safe as First Step Towards Its Potential Use in Controlling MRSA in Hospitals...
About this update from Niobay Metals Inc.
[{"type":"text","content":"\n\n\n\nProduct Shown to be Safe as First Step Towards Its Potential Use in\nControlling MRSA in Hospitals\n\n\nNovel, Topically Applied, Non-Antibiotic, Anti-Infective Compound to\nCommence a Phase IIa Study in Humans by January 2008\n\n\nEMERYVILLE, CALIF., November 26 /CNW/ - NovaBay Pharmaceuticals, Inc.\n(AMEX & TSX: NBY, http://novabaypharma.com), a biopharmaceutical company\ndeveloping products for the treatment or prevention of a wide range of\nbacterial and viral infections, reports results from a Phase I trial studying\nthe lead Aganocide compound, NVC-422, a novel non-antibiotic anti-infective\nthat has shown potent in vitro activity against major pathogens, including\nmethicillin-resistant Staphylococcus aureus (MRSA).\n\n\nNasal colonization of Staphylococcus aureus, including MRSA, is an\nimportant risk factor that predisposes the carrier to infections during\ninvasive hospital procedures. The results of the Phase I trials show that when\ntopically applied to the anterior nares (the lower nasal passages), NVC-422\nappears safe and well tolerated with undetectable systemic exposure. Based on\nthese results, NovaBay has commenced a second Phase I trial to test the safety\nof NVC-422 at a higher dose and expects to have results from this second study\nby early 2008. In parallel with the second Phase I study, NovaBay expects to\ncommence a Phase IIa study by January 2008 in healthy volunteers that are\ncarriers of Staphylococcus aureus in their nasal passages.\n\n\n"AgaNase (NVC-422 for nasal applications) has the potential to be an\nimportant treatment option for physicians in the ongoing fight against\ndrug-resistant infections, including MRSA, a growing public health concern in\nthe hospital," said Dr. Ron Najafi, NovaBay's Chairman and Chief Executive\nOfficer. "With this excellent preliminary safety data, we intend to move\nforward into additional trials to study the safety and efficacy of NVC-422 in\nvolunteers and patients at risk of infection."\n\n\nIn this double-blind placebo controlled Phase I trial of AgaNase, safety\nand tolerability were tested following repeated applications of AgaNase, using\nvarious concentrations (0.1% and 0.3%) and regimens, applied by spray or swab\nto the anterior nares. A total of ninety-six subjects were enrolled and\ncompleted the study. Any adverse event...