NEW YORK, Oct. 1, 2015 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, today announced that its OneStep-2 pivotal Phase 3 clinical trial has reached the 50% enrollment milestone. OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials (180 patients per clinical trial) being conducted under a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration and Dipexium for evaluation of Locilex® for the treatment of patients with mild infections of diabetic foot ulcers.
As of today, OneStep-1 and OneStep-2 are approximately 56% and 50% enrolled, respectively. In addition, in the aggregate, 62 clinical trial centers are open for enrollment across both pivotal Phase 3 clinical studies. The Company is targeting a New Drug Application (NDA) submission in the second half of 2016. More information about the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials is available at www.clinicaltrials.gov.
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