Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), and research collaborators, JMI Laboratories, announced that new Locilex® microbiology data were presented at the American Society for Microbiology's Interscience Conference of Antimicrobial Agents and Chemotherapy and International Society of Chemotherapy's International Congress of Chemotherapy and Infection (ICAAC/ICC 2015) scientific conference in San Diego, California, September 17-21, 2015.
In a poster presentation entitled "In Vitro Activity of Pexiganan Tested Against Pathogens with Elevated MICs to Topical Antimicrobials," investigators stated that pexiganan, the active pharmaceutical ingredient in Locilex®, demonstrated potent in vitro activity against a broad spectrum of Gram-positive and Gram-negative bacteria selected as having elevated MIC90 (minimum inhibitory concentration) values to topical antibiotics, including bacitracin, polymyxin B, neomycin, mupirocin, retapamulin, and fusidic acid. Pexiganan also demonstrated activity against gentamicin-susceptible and gentamicin-resistant isolates. A copy of the ICAAC/ICC poster presentation can be found on Dipexium's website at www.dipexiumpharmaceuticals.com/locilex/key-publications.
Pexiganan's MIC90 values for each of the organism groups studied, including difficult-to-treat Gram-positive staphylococci, beta-hemolytic streptococci, enterococci, viridans group streptococci, as well as Gram-negative Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, and Acinetobacter baumannii were below the concentration of pexiganan in Locilex®'s topical cream formulation, indicating that the concentration of pexiganan in the current commercial scale batches should be sufficient to inhibit most infecting organisms in superficial skin and wound infections amenable to treatment with a topical antimicrobial. The authors also noted a lack of cross-resistance between pexiganan and the topical antimicrobials tested, citing, for example, that against all Staphylococcus aureus isolates tested, pexiganan MIC50 and MIC90 values were 16 µg/mL.
Robert K. Flamm, Ph.D., Director, Antimicrobial Development at JMI Laboratories, and principal investigator for the study, said, "JMI Laboratories has now completed four microbiology studies of pexiganan on behalf of Dipexium. Data from these studies consistently demonstrate pexiganan's potent bactericidal activity against a broad spectrum of bacteria, including those highly resistant to currently marketed antimicrobials, whether systemic or topical. In the current environment of emerging multi-drug resistant bacteria, pexiganan is a potentially important therapeutic agent in the treatment of superficial skin and wound infections."
"No antibiotic is currently approved in the US or European Union for the treatment of mild infections of diabetic foot ulcers (Mild DFI)," stated David P. Luci, President & Chief Executive Officer of Dipexium. "These pexiganan microbiology data provide additional strong support for the rationale behind our on-going pivotal Phase 3 program in patients with Mild DFI, as well as Locilex®'s potential clinical development in the treatment of other skin and wound infections."
Dipexium Pharmaceuticals, Inc.