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NovaBay Partner Galderma Expands Phase 2b Trial Enrollment To South Africa

Stocks in this article: NBY

Global Impetigo Study to Enroll Patients in Four Countries

EMERYVILLE, Calif., Feb. 5, 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 partner Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology, has initiated the South African arm of its Phase 2b clinical study of a proprietary topical formulation of NVC-422 (CD07223) for the treatment of impetigo.

"The treatment of impetigo is a significant unmet need in South Africa, and the expansion of this international study into that market is an important step for our partner Galderma," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. "Our hope is that our Aganocide treatment will be able to bring relief to the patients suffering from impetigo, many of them children, around the world."

Designed to confirm efficacy and evaluate two different dosage regimens, the study is expected to enroll over 300 patients at 24 clinical sites in four countries worldwide. The first patients were enrolled in the U.S. arm of the study in September 2012. Galderma previously established preclinical and clinical safety for topical NVC-422, including the successful completion of safety studies involving more than 300 healthy volunteers, as well as the feasibility of manufacturing scale-up and long-term shelf-life.

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. There have been increasing reports of skin infections caused by MRSA from local and regional health departments, physicians, schools, and daycare facilities. 1 A review article published recently in Pediatric Dermatology 2 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 previous Phase 2 clinical study, NVC-422 was shown to be safe and well tolerated. NVC-422 gel also demonstrated a clinical response rate of 92% and a microbiological response rate of 95% at the same dosage used in the current Phase 2b study. Furthermore, in a subset of patients who enrolled in the study with MRSA infections, NVC-422 gel demonstrated clinical and microbiological response rates of 100%. 3 Additionally, NVC-422 was rapidly bactericidal against 55 clinical isolates of MRSA acquired from a database of patients in the U.S. and Europe. 

1Pollard JM, Rice CA, (2007) MRSA: Antibiotic resistant staph infection; HealthHints Newsletter. Full text available: http://fcs.tamu.edu/health/healthhints/2007nov/mrsa.php

2Bangert 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

3Iovino 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/pmc/articles/PMC3160610/

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.

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