Dipexium Reaches 75% Enrollment Milestone in Pivotal Phase III Trials
Dipexium Pharmaceuticals, Inc. recently announced its OneStep-1 and OneStep-2 pivotal Phase III clinical trials have reached the 75% enrollment milestone, in the aggregate, with each study having enrolled nearly the same number of patients. OneStep-1 and OneStep-2 are identical, pivotal Phase III clinical trials (180 patients per clinical trial) being conducted under a Special Protocol Assessment (SPA) agreement between the US FDA and Dipexium for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.
The company anticipates completing these trials in the second half of 2016 and is targeting a New Drug Application (NDA) submission with the US FDA in the first half of 2017 and a Marketing Authorization Application (MAA) submission with the European Medicines Agency in the second half of 2017. More information about the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials is available at www.clinicaltrials.gov<;http://www.clinicaltrials.gov>.
Dipexium Pharmaceuticals, Inc. is a late-stage pharmaceutical company focused on the development and commercialization of Locilex (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic 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 and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA). For more information, visit www.dipexiumpharmaceuticals.com.
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