NovaBay Pharmaceuticals Mid-Year Clinical Update
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."
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.
NovaBay's first-in-class Aganocide compounds, led by auriclosene, are patented, topical antimicrobials with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides are not subject to bacterial or fungal resistance, which has been demonstrated in in vitro and in vivo studies. Having demonstrated clinical efficacy in Phase 2 proof-of-concept clinical studies, auriclosene has the potential to treat a wide range of local, non-systemic infections.
Distinct from NovaBay's Aganocides drug platform, NeutroPhase has been cleared by the U.S. Food and Drug Administration as a 510(k) medical device and is indicated as a skin and wound cleanser. NeutroPhase, which targets the 6 million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers, is the only pure hypochlorous acid solution available today. For additional information, visit: www.neutrophase.com.
This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the expected timing of enrollment and commencement of clinical trials, expected timing of announcement of results of clinical studies, and expected future financial results. The words "continued," "expected," "will be," "believe", "expect", "anticipate", "would," "planning" and other words (and all variations of these words that imply future events), identify these statements as forward looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company's product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company's intellectual property or trade secrets, the company's ability to obtain additional financing as necessary and unanticipated research and development and other costs. These risks and others are detailed in NovaBay's latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading "Risk Factors." 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.
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