Dipexium Pharmaceuticals, LLC has signed an agreement with the Food and Drug Administration of the United States (FDA) on a Special Protocol Assessment (SPA ) for the phase 3 clinical study in the treatment of mild infections of diabetic foot ulcers with Locilex  (pexiganan acetate cream 1%), a peptide antibiotic formulated as a topical cream. The agreement stipulates that the ESP experiment protocol proposed clinical endpoints and analyzes provided are acceptable to the FDA in support of an application for approval.

"We are pleased with the agreement with the FDA, which provides us with developing regulations and clearly defined marketing authorization of Locilex  in mild infections of diabetic foot ulcers," said Robert J. DeLuccia co-director Dipexium. "We believe that the pivotal DPX-305 will provide clinical justification for establishing Locilex  as the standard of care for the treatment of patients with moderately infected ulcers of diabetic foot, a growing market in the world, currently estimated at $1.5 billion, "said David P. Luci, co-director of Dipexium.

The DPX-305 study will be a phase 3 study pexiganan cream 1% (Locilex) randomized, double-blind, multicentre, superiority, placebo applied twice daily for 14 days to treat adult patients of mild infections of diabetic foot ulcers in the United States. The DPX-305 study will involve approximately 180 patients and the primary efficacy endpoint is the healing of the infection following medical judgment of each physician in accordance with standard guidelines set out in the 2012 guide clinical practice for the diagnosis and the treatment of diabetic foot infections (the "Guidelines for the treatment DFI") of the League of American infectious diseases.

The ESP process (SPA) is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis of a license application biological product (Biologics "BLA") or permission of marketing ("New Drug Application"). The final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit / risk of treatment demonstrated in the phase 3 and, in our case, the results of the study DPX-306 an identical phase 3 to be conducted simultaneously with the study of DPX-305.

Locilex  (cream pexiganan acetate 1%) is a broad spectrum antimicrobial peptide which is chemically synthesized from the skin of the African clawed frog. Locilex  has a novel mechanism of bactericidal antibiotics rare among currently on the market that generally inhibit the growth of pathogens. Locilex  (positively charged) form an alpha helix and disrupts the lipid bilayer of the bacterial cell wall (negatively charged), thus creating an opening in which the intracellular fluid, extracellular fluid and water penetrate the bacterial cell lysis of effectively.

Locilex  has been successfully used in phase 3 clinical trials demonstrating a significant clinical benefit in patients with mild to moderate infections of the diabetic foot. Dipexium supported the clinical database Locilex  recently by studies in microbiology emphasize the sensitivity of resistant bacteria Locilex ™, including Staphylococcus aureus resistant to methicillin (MRSA), vancomycin-resistant vancomyn (VRE), extended-spectrum ß-lactamase (ESBL) bacteria and multi-drug resistant (MDR). Due to the increasing prevalence of bacteria in the world multi-drug resistant bacteria and XDR in all types of bacterial skin infections, Locilex  can provide an important therapeutic advance.

In studies conducted recently in microbiology, the active ingredient Locilex has demonstrated a high level of efficacy against multi-resistant bacteria (MDR) Staphylococcus aureus resistant to methicillin (MRSA), vancomycin-resistant (VRE) and extended spectrum ß-lactamase (ESBL) and other resistant pathogens. Due to the increasing prevalence in the world of multi-drug resistance of bacteria and bacteria XDR in all types of bacterial skin infections, Locilex  can provide an important therapeutic advance.

In clinical trials, no safety issues were reported on more than 1000 human subjects exposed to Locilex. In addition, no antimicrobial resistance or cross-resistance with other antibiotics has been observed to date. Because Locilex ™ does not absorb below the subcutaneous layer of the skin, systemic resistance to the drug can develop, unlike almost all other currently available antibiotics.

If approved by the FDA, Locilex  would be the first topical antibiotic approved for the treatment of all levels of diabetic foot infection (mild, moderate or severe DFI).