Clinical Results From Three Auriclosene Phase 2 Trials Expected in Second Half of This Year
EMERYVILLE, Calif., June 11, 2013 (GLOBE NEWSWIRE) -- NovaBay Pharmaceuticals, Inc., (NYSE:NBY), a clinical-stage biotechnology company focused on the topical, anti-infective market, today announced several business and clinical updates for the remainder of 2013.
Dr. Ron Najafi, Chairman and CEO of NovaBay Pharmaceuticals, explained, "This is an important year for NovaBay. Each of our three auriclosene phase 2 clinical studies – in urology, dermatology, and ophthalmology – is expected to report data in the second half of 2013. We are excited that the differentiated products we are developing will positively impact patients' lives once approved."Urology: NovaBay is conducting a Phase 2 clinical study of Auriclosene (NVC-422) Flush Solution in the management of urinary catheter blockage and encrustation in patients with long-term indwelling catheters. This study uses auriclosene to maintain the patency of urinary catheters in patients suffering from spinal cord injury and/or neurogenic bladder. In Part 3 of the ongoing Phase 2 study, designated CL1001, subjects with indwelling catheters receive irrigations on two days per week with either saline or auriclosene. Both the incidence of complete catheter blockage and the degree of catheter encrustation with crystallized biofilm are measured. To be enrolled in the study, subjects are required to have a recent repeated history of urinary catheter encrustation and/or blockage. Top-line results from the trial are expected in the third quarter of 2013. For more information on this study, please see: http://www.clinicaltrials.gov/ct2/show/NCT01243125 . Dermatology: NovaBay has partnered with Galderma, a leading dermatology company, to develop Auriclosene Gel for treatment of highly contagious skin infection, impetigo, which occurs most commonly in children. Designed to confirm efficacy and evaluate two different dosage regimens, the study is expected to enroll more than 300 patients at 24 clinical sites in multiple countries. The first patient was enrolled in the study in September 2012. Galderma expects to complete enrollment in the third quarter of 2013, and top-line results are expected in the fourth quarter of 2013. For more information on this study, see: http://www.clinicaltrials.gov/ct2/show/NCT01670032 Ophthalmology: The Phase 2b trial, BAYnovation, is investigating Auriclosene Ophthalmic Solution as a treatment for adenoviral conjunctivitis, a highly contagious form of "pink eye." There is no approved treatment for this infection in the world. Enrollment in this trial began in May 2012 and is expected to complete in the fourth quarter of 2013. BAYnovation is a multi-center, randomized clinical study expected to enroll approximately 450 patients with adenoviral conjunctivitis throughout the United States, India and Brazil. The study is being conducted by over 60 clinical investigators worldwide. For more information on BAYnovation, please visit: www.baynovation.org or www.clinicaltrials.gov/ct2/show/NCT01532336 . About NovaBay Pharmaceuticals, Inc. Going Beyond Antibiotics NovaBay Pharmaceuticals is a biotechnology company focused on addressing the large unmet therapeutic needs of the global, topical anti-infective market with auriclosene. The Company's four core business units – DermaBay, UroBay, EyeBay and MediBay – are developing products in dermatology, urology, ophthalmology, and wound care areas.
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