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Galderma And NovaBay Enroll First Patients In Phase 2b Clinical Study Of NVC-422 For Impetigo

Impetigo is a highly contagious skin infection that mainly affects infants and children, which is caused by Staphylococcus aureus, including MRSA (methicillin-resistant Staphylococcus aureus), Streptococcus pyogenes, or both.  A review article published recently in Pediatric Dermatology 1 reported that antibiotic-resistant organisms have become more prevalent in impetigo, and that the disease should be treated with topical agents that will reduce antibacterial resistance and minimize the incidence of adverse events. In a Phase 2 clinical study, NVC-422 was shown to be safe and well tolerated, and demonstrated a 100% response rate for treating patients with impetigo caused by MRSA, whether MRSA was the sole organism or in a mixed infection 2 and more than a 93-95% response to all strains and full clinical response. Additionally, NVC-422 was rapidly bactericidal against 55 clinical isolates of MRSA acquired from a database of patients in the U.S. and Europe. 

1Bangert S, Levy M, and Hebert AA, (2012) Bacterial Resistance and Impetigo Treatment Trends: A Review; Pediatric Dermatology Vol. 29 No. 3 243–248. Abstract available: http://onlinelibrary.wiley.com/doi/10.1111/j.1525-1470.2011.01700.x/abstract

2Iovino SM, Krantz KD, Blanco DM, Fernández JA, Ocampo N, Najafi A, Memarzadeh B, Celeri C, Debabov D, Khosrovi B, Anderson M., (2011) NVC-422 topical gel for the treatment of impetigo.; Int J Clin Exp Pathol. Aug 15;4(6):587-95. Abstract available: http://www.ncbi.nlm.nih.gov.elibrary.einstein.yu.edu/pubmed/21904634

About NovaBay Pharmaceuticals, Inc.

Going Beyond Antibiotics

NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products.

www.NovaBayPharma.com

Aganocide ® Compounds NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic molecules 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 possess a reduced likelihood that bacteria or viruses will be able to develop resistance, which is critical for advanced anti-infectives. 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, caused primarily by S. aureus and Group a b-hemolytic streptococci.  
  • Ophthalmology - NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis. Enrollment into a global Phase 2b clinical study has begun with top-line data expected in the first half of 2013.  
  • Urology NovaBay's urinary catheter irrigation solution containing NVC-422 is currently enrolling patients in its Phase 2 proof-of-concept clinical studies, 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 Part A of this study and expects to announce top-line results from Part B later in 2012.

NeutroPhase ® NovaBay is also developing NeutroPhase, which is an FDA 510(k)-cleared product for advanced wound care. We believe that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the six-million-patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers.

For additional information, visit: www.neutrophase.com .

Stay informed on NovaBay's progress:

About Galderma

Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime while serving healthcare professionals around the world. The company has 31 wholly-owned affiliates with a worldwide network of distributors and more than 4,000 employees. Galderma's extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.

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