Dipexium Pharmaceuticals Announces Successful Completion and Initial Results of Phase 1 Skin Sensitization Trial of Locilex®
Cumulative data from skin irritation and skin sensitization trials demonstrate excellent local tolerability
NEW YORK, Feb. 17, 2015 /PRNewswire/ -- Dipexium Pharmaceuticals, Inc.DPRX, +2.27% today announced successful completion and initial results of DPX-120, a Phase 1 skin sensitization trial of Locilex® (pexiganan cream 0.8%), the Company's novel, broad-spectrum topical antibiotic peptide.
DPX-120 was a single-center, double-blind study in healthy adult subjects with the primary objective of evaluating the potential of Locilex® and its vehicle cream to induce contact sensitization by repetitive application to human skin. Volunteers received applications of Locilex®, vehicle cream, and a low irritant control 3 times each week for 3 weeks during an induction phase, followed by 2 weeks without dosing and then a single challenge dose to intact skin. Visual skin irritation assessments were performed by trained and blinded evaluators using a well-established, FDA-recognized standardized rating scale.
In total, 203 evaluable healthy adult subjects were assessed for contact sensitization. The low irritant control showed no contact sensitization as expected, indicating a successful trial. Vehicle cream also showed no induction of contact sensitization. Locilex® demonstrated low potential for inducing contact sensitization. In total, only three out of 203 evaluable subjects were characterized as sensitized, which was better than anticipated by the Company and its scientific consultants based upon published studies conducted with other topical antibiotics.
Dipexium's Chief Executive Officer, David P. Luci stated: "We are pleased with the results of this trial and we expect these data will satisfy the regulatory requirement for evaluating the contact sensitization potential of Locilex® with our new formulation. With the completion of both this trial and our recently completed contact irritation trial, DPX-110, we are confident that Locilex® will continue to demonstrate excellent local tolerability. This is particularly relevant in view of published studies which indicate that other topically applied antibiotics, such as neomycin, may produce local skin reactions in a clinically important percentage of patients."
Dipexium's Executive Chairman, Robert J. DeLuccia added: "The low potential for contact sensitization further supports the anticipated favorable safety and tolerability profile of our novel topical antibiotic. Our pivotal Phase 3 placebo-controlled clinical trials, OneStep-1 and OneStep-2, are actively enrolling patients and we look forward to completing these pivotal trials in the coming months." The Phase 3 placebo-controlled program is being conducted by the Company under a Special Protocol Assessment (SPA) Agreement with the FDA.
About Dipexium Pharmaceuticals, Inc.
Dipexium Pharmaceuticals, Inc. DPRX, +2.27% is a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide. Initially, Locilex® is targeted for the treatment of mild infections of diabetic foot ulcers. Based on a compilation of available clinical and microbiology data, Locilex® is also considered a promising product candidate to treat other mild and moderate skin and skin structure infections, including infected decubitus ulcers, infected burns, infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).