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NovaBay Pharmaceuticals Initiates Phase 2 Clinical Trial For The Treatment Of Urinary Catheter Blockage And Encrustation

NovaBay's commercialization strategy for its Urology Business Unit is to retain commercial rights in the large U.S. market and license rights to Europe and the Asia/Pacific.

Development Pathway

In 2008, after extensive preclinical testing which confirmed NVC-422's ability to maintain catheter patency over extended periods, NovaBay entered into the urology therapeutic arena with the filing of an IND with the Food and Drug Administration. After IND clearance, NovaBay successfully concluded a 32-volunteer Phase 1 human trial that indicated the product was safe at the proposed dose. Upon successful completion of this Phase 1 trial, NovaBay entered an exploratory Phase 2 study in patients with severe bacteriuria, or colonization of bladder with bacteria but not yet considered a symptomatic urinary tract infection.  The study showed that NVC-422 was well tolerated and reduced or eliminated certain pathogens in the urine. No severe adverse events were reported.

For more information on the Phase 2 trial, visit: http://www.novabaypharma.com/investors/release/apr_15_2010

About NovaBay's Aganocide Compounds

NovaBay's Aganocide compounds are novel, broad-spectrum, fast-acting, synthetic N-chlorinated antimicrobial molecules designed to mimic the body's defense against infection. When applied to the site of an infection, these compounds maintain biological activities while demonstrating improved solution stability over naturally occurring N-chlorinated antimicrobial molecules.  In July 2010, NovaBay announced positive results in a 129-patient, Phase 2a impetigo skin infection study. The results showed 92% of the patients in NovaBay's highest dose were cured of the highly contagious infection following seven days of treatment with NovaBay's lead Aganocide compound (NVC-422) topical gel. Patients in the study infected with methicillin-resistant Staphylococcus aureus (MRSA) impetigo infection were successfully treated. Additionally, Aganocide compounds have shown good in-vitro activity against viruses and fungi and 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. These are novel, synthetic anti-infectives with activity against bacteria, fungi and viruses, and are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance. 

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