-Data from Three Phase 2 Trials of Lead Aganocide Compound Anticipated in 2013 -
- Phase 3 Registration Trials Expected in 2014 -
EMERYVILLE, Calif., Feb. 20, 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 World Health Organization (WHO) has approved the international nonproprietary name (INN) "auriclosene" (pronounced awr-rih-CLO-zeen) for the Company's lead Aganocide® compound NVC-422. INNs facilitate the identification of active pharmaceutical ingredients, and each INN is a globally recognized unique name.
Aganocides are NovaBay's first-in-class topical antimicrobial compounds, which are active against viruses, fungi, and bacteria, including the bacteria that grow and thrive under biofilm. Testing in-vitro and in-vivo has shown that these non-systemic, non-antibiotic compounds do not give rise to bacterial or fungal resistance. Phase 2 studies for auriclosene are currently ongoing in urology, ophthalmology, and dermatology.
Dr. Ron Najafi, Chairman and Chief Executive Officer, said, "Obtaining the INN for our lead clinical compound NVC-422 confirms that our clinical development is on track, and we anticipate progression into Phase 3 development in each of our three Aganocide programs. We also intend to conduct a Phase 2a proof-of-concept study for auriclosene in an additional ophthalmic indication. NVC-422, now auriclosene, is the first of our proprietary Aganocides to receive a nonproprietary name."
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 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 second 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 has begun, and clinical data results are 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 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: NovaBay Pharmaceuticals, Inc. Thomas J. Paulson (Investors) Chief Financial Officer (510) 899-8809 email@example.com The Ruth Group Stephanie Carrington / Nicole Greenbaum (Investors) (646) 536-7017 / 7009 firstname.lastname@example.org / email@example.comSource:NovaBay Pharmaceuticals, Inc.