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news.Dipexium Pharmaceuticals has enrolled first patient in the second of two pivotal Phase III clinical trials, called OneStep-1 and OneStep-2, evaluating its new, broad-spectrum, topical antibiotic peptide, Locilex (pexiganan cream 0.8%), to treat patients mild infections of diabetic foot ulcers, or Mild DFI.
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Presently, there are no antibiotics, systemic or topical, which are specifically approved by the US Food and Drug Administration (FDA) to treat patients with Mild DFI.
FDA has agreed to a Special Protocol Assessment (SPA) with Dipexium for Locilex’s pivotal Phase III clinical trial program in Mild DFI.
Dipexium president and chief executive officer David Luci said, "We are delighted to have OneStep-1 and OneStep-2 actively enrolling patients simultaneously and we expect to continue the momentum throughout H2 2014."
Both OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials conducted simultaneously.
The two trials will each enrol about 180 patients at 20 separate centers in the US.
The primary objective is to establish the clinical superiority and safety of topical Locilex plus standard local wound care compared to placebo cream plus standard local wound care, in the treatment of Mild DFI.
Dipexium executive chairman Robert DeLuccia said: "We look forward to completing the clinical and regulatory pathway for Locilex and proceeding with the submission of our new drug application (NDA) in H2 2015 as planned."
In the trials, patients will be 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.