BAYnovation Phase 2b Trial for the Treatment of Viral Conjunctivitis Spans Three Continents
EMERYVILLE, Calif., April 8, 2013 (GLOBE NEWSWIRE) -- NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY), a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides®, today announced the enrollment of the first patients in Brazil into its global Phase 2b clinical trial, BAYnovation. The trial is investigating Auriclosene (NVC-422) Ophthalmic Solution as a treatment for adenoviral conjunctivitis, a highly contagious form of "pink eye" for which there is no approved treatment anywhere in the world.
BAYnovation is a multi-centered, 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, including approximately 11 sites in Brazil and 24 sites in India.
BAYnovation is designed to evaluate the efficacy of Auriclosene Ophthalmic Solution in treating the adenoviral infection, specifically clearing the associated red eye, blurred vision, and reducing lingering effects left by the infection. Clinical data results are expected in the second half of 2013.
Prof. Dr. Rubens Belfort, Jr., Professor, Federal University of São Paulo and President SPDM, Hospital Sao Paulo, said, "Adenovirus has caused large epidemics of pink eye in Brazil, and the ocular infections caused by these strains causes blurred vision which can last for weeks to years. We are very pleased to be a part of this global clinical study. A treatment for adenoviral conjunctivitis is badly needed to combat the epidemics caused by adenovirus."
Dr. David Stroman, Ph.D., Senior Vice President, Ophthalmology at NovaBay Pharmaceuticals, said, "With the enrollment of patients in Brazil, our global BAYnovation study now has active sites on three continents, as planned. Patients with adenoviral conjunctivitis in the U.S., India, and Brazil are actively participating in the development of this important new product. Because of the design features of BAYnovation, we are assessing the clinical and virological effectiveness of auriclosene as well as assessing its ability to reduce the sight-threatening effects of the infection."
Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay, said, "We are pleased with the progress these global teams have made. With all three countries now enrolling in the BAYnovation study, we are closer to providing auriclosene to patients suffering from adenoviral conjunctivitis, and who have no other acute treatment option."
NovaBay has partnered with leading CROs – Quintiles Research in India, Chiltern International in Brazil, and Symbio, LLC in the U.S. – to conduct BAYnovation. 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 anti-infective market with its two distinct categories of compounds, Aganocides® and NeutroPhase® Skin and Wound Cleanser. The Company's four core business units, DermaBay, UroBay, EyeBay and MediBay, are developing treatments that tackle infections in the dermatology, urology, ophthalmology, and wound care areas.
NovaBay's first-in-class Aganocide compounds, led by auriclosene (NVC-422), 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 is suited to treat and prevent a wide range of local, non-systemic infections. NovaBay's clinical development activities are focused on three disease areas:
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of auriclosene for treatment of highly contagious skin infection, impetigo, which occurs most commonly in children. Enrollment into a global Phase 2b clinical study has begun and clinical data results are expected in second half of 2013.
Ophthalmology – NovaBay is developing an eye drop formulation of auriclosene for treating adenoviral conjunctivitis, a highly contagious viral eye infection for which there is no approved acute treatment. Enrollment into a global Phase 2b clinical study has begun, and clinical data results are expected in the second half of 2013.
Urology – NovaBay's urinary catheter irrigation solution containing auriclosene is currently in a Phase 2b study, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from the Phase 2a study and is evaluating the effect of an alternate more potent formulation of auriclosene in Phase 2b. Results are expected in the mid 2013.
NeutroPhase is the only pure hypochlorous acid (HOCI) skin and wound cleanser cleared by the U.S. Food and Drug Administration (FDA) to target the six-million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. The saline-based solution is the only wound cleanser on the market to include a stabilized, pure form of HOCl shown in studies to kill bacteria in solution, including flesh-eating bacteria. For additional information, visit: www.neutrophase.com.
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This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse 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. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's 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.
CONTACT: Contact Information NovaBay Pharmaceuticals, Inc. Thomas J. Paulson (Investors) Chief Financial Officer (510) 899-8809 firstname.lastname@example.org The Ruth Group Stephanie Carrington / Nicole Greenbaum (Investors) (646) 536-7017 / 7009 email@example.com / firstname.lastname@example.orgSource:NovaBay Pharmaceuticals, Inc.