Dipexium Pharmaceuticals Initiates Second Of Two Pivotal Phase 3 Clinical Trials Of Locilex® in Patients With Mild Infections Of Diabetic Foot Ulcers

Dipexium Pharmaceuticals, Inc.

today 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 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 P. Luci, President & Chief Executive Officer of Dipexium. Robert J. DeLuccia, Executive Chairman of Dipexium, added "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." OneStep-1 and OneStep-2 Trial Design OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials conducted simultaneously that will each enroll approximately 180 patients at 20 separate centers in the United States. The primary objective is to establish the clinical superiority and safety of topical Locilex® plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. 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. The primary endpoint of the trials is clinical response, which is defined as infection resolved per the judgment of each treating physician using the 2012 Infectious Disease Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections. Secondary endpoints include microbiological success, which is defined as complete microbiological response, as well as the incidence and severity of adverse events. Additional information on the OneStep-1 and OneStep-2 trials can be found at www.clinicaltrials.gov or at Dipexium's website at www.dipexiumpharmaceuticals.com. Video of presentations made at Dipexium's Phase 3 Investigators' Meeting conducted in May 2014 can be found at Dipexium's website. These include presentations by Benjamin A. Lipsky, MD, FACP, FIDSA, FRCP, Chair of the OneStep trials and lead author of the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections, as well as Warren S. Joseph, DPM, FIDSA, Vice-Chair of the OneStep trials, and co-author of the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections.