Dipexium Pharmaceuticals Inc. announced it has initiated patient enrollment in the second of two pivotal Phase 3 clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex (pexiganan cream 0.8%), the company’s novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI.
According to medical literature, approximately 47% of all patients with diabetic foot infections first present at the mild stage. Currently, there are no antibiotics, systemic or topical, which are FDA approved specifically to treat patients with Mild DFI. The U.S. Food and Drug Administration (FDA) has agreed to a Special Protocol Assessment (SPA) with Dipexium for Locilex’s pivotal Phase 3 clinical trial program in Mild DFI.
“We are delighted to have OneStep-1 and OneStep-2 actively enrolling patients simultaneously and we expect to continue the momentum throughout H2 2014,” said David Luci, president & chief executive officer of Dipexium.
Robert DeLuccia, executive chairman of Dipexium, added that the company “look[s] forward to completing the clinical and regulatory pathway for Locilex and proceeding with the submission of [the] new drug application (NDA) in H2 2015 as planned.”
Date: July 21, 2014
Source: Dipexium
