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July 17, 2014
08:04 EDTDPRXDipexium Pharmaceuticals begins Phase 3 clinical trial of Locilex for foot ulcer
Dipexium Pharmaceuticals has initiated patient enrollment in the first of two pivotal Phase 3 clinical trials evaluating Locilex, the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI. Currently, there are no antibiotics, systemic or topical, which are FDA approved specifically to treat patients with Mild DFI. The FDA has agreed to a Special Protocol Assessment with Dipexium for Locilex's pivotal Phase 3 clinical trial program in Mild DFI.
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August 20, 2015
08:08 EDTDPRXDipexium Pharmaceuticals reaches 50% enrollment in Locilex Phase 3 trial
Dipexium Pharmaceuticals' OneStep-1 Phase 3 clinical trial has passed the 50% enrollment milestone. OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials being conducted under a Special Protocol Assessment agreement between the FDA and Dipexium for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers. The company anticipates completing enrollment and filing a New Drug Application for FDA approval in 2016.

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