Phase 2b BAYnovation Study for the Treatment of Viral Conjunctivitis Includes 60 Clinical Sites Worldwide
EMERYVILLE, Calif., Jan. 3, 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 that the first patients have been enrolled in India into its global Phase 2b BAYnovation clinical study, investigating NVC-422 Ophthalmic Solution as a treatment of adenoviral conjunctivitis, a highly contagious form of "pink eye" for which there is an unmet ocular medical need.
BAYnovation is a multi-centered, randomized clinical study expected to enroll approximately 450 patients with confirmed adenoviral conjunctivitis throughout the United States, India and Brazil. The study will be conducted in over 60 clinical trial sites worldwide, with 24 sites in India. BAYnovation is designed to evaluate NVC-422's efficacy in eliminating the adenoviral infection, specifically treating the associated red eye, clearing the blurred vision, and reducing lingering effects left by the adenoviral conjunctivitis. Enrollment is now underway in both U.S. and India, and is expected to be initiated in Brazil. Clinical data results are expected in the second half of 2013.
"Because the adenovirus can remain active for weeks, adenoviral conjunctivitis is highly contagious and has been known to lead to outbreaks of epidemic proportions in India," stated Prashant Garg, MD, L V Prasad Eye Institute, Hyderabad, India. "NVC-422 Ophthalmic Solution would be a welcome addition within our treatment regimen, as there is no available cure for adenoviral pink eye. Treatments usually deal with relieving irritation and discomfort, and patients must suffer with the infection until it plays its course. Meanwhile, they are spreading the infection to those around them."
Dr. David Stroman, Ph.D., Senior Vice President, Ophthalmology at NovaBay Pharmaceuticals, stated, "We are pleased to see that enrollment in the BAYnovation global study is underway in India and believe that the country's participation will prove invaluable in completing the trial. With previous clinical experience from the Phase 2a trial showing the compound to be effective in eliminating the virus, we are hopeful that NVC-422 Ophthalmic Solution will represent a significant advancement in the treatment of adenoviral conjunctivitis."
Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay, stated, "We'd like to thank our CRO in India, Quintiles, for the great efforts they have made in facilitating the recruitment of patients for the BAYnovation study. Adenoviral conjunctivitis remains the greatest unmet need in ocular infections and we are pleased to be bringing NVC-422 one step closer to patients and physicians in need of a therapeutic 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.
Aganocide® Compounds
NovaBay's first-in-class Aganocide compounds, led by 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, NVC-422 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 NVC-422 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 the 2nd half of 2013.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 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 is underway with clinical data results expected in the second half of 2013.
Urology – NovaBay's urinary catheter irrigation solution containing NVC-422 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 NVC-422 in Phase 2b. Results are expected in the first half of 2013.
NeutroPhase®
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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Forward-Looking Statements
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.