Dipexium Provides Update on Availability of Results from Pivotal Phase 3 Clinical Trials with Locilex®
NEW YORK, Oct. 20, 2016 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX) ("Dipexium" or the "Company"), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antimicrobial peptide in development for the treatment of mild infections of diabetic foot ulcers, today provided an update on the status of results from the two pivotal Phase 3 clinical trials (OneStep-1 and OneStep-2). Data tables and listings from both of these trials are currently being produced and evaluated by the Company's scientific advisors according to our pre-specified data review procedure.
David P. Luci, President and Chief Executive Officer of Dipexium stated, "We believe the process is nearing completion and anticipate announcing the data later this month after the scientific advisory team informs us of the unblinded results."
About Dipexium Pharmaceuticals
Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antimicrobial peptide. Initially, Locilex is targeted for the treatment of mild infections of diabetic foot ulcers. Based on a compilation of available clinical and microbiology data, Locilex is also considered a promising product candidate to treat other mild and moderate skin and skin structure infections, including infected decubitus ulcers, infected burns, infected surgical wounds, infected animal bites and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA). For more information, visit www.dipexiumpharmaceuticals.com.
About OneStep-1 and OneStep-2 Pivotal Phase 3 Clinical Trials
OneStep-1 and OneStep-2 were identical, double-blind, placebo-controlled clinical trials conducted simultaneously that enrolled a total of 389 patients at 59 separate centers in the United States. The primary objective was to establish the clinical superiority and safety of topical Locilex® plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. Patients were randomized 1:1 to receive either topical Locilex® plus standard local wound care or placebo cream plus standard local wound care for 14 days, with final evaluation at day 28. The primary endpoint of the trials is clinical response, which is defined as infection resolved per the judgment of each treating physician using the 2012 Infectious Disease Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections. Secondary endpoints include microbiological success, which is defined as complete microbiological response, as well as the incidence and severity of adverse events. Other endpoints include several measurements with respect to the time and extent of wound healing. The FDA has agreed to a Special Protocol Assessment (SPA) with Dipexium for Locilex®'s pivotal Phase 3 clinical trial program in Mild DFI.
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