Dipexium Pharma (DPRX) Announces Locilex Phase 3s Missed Primary Endpoints
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Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX) announced that the OneStep-1 and OneStep-2 Phase 3 clinical trials of Locilex (pexiganan cream 0.8%) in patients with mild infections of diabetic foot ulcers (Mild DFI) did not meet the primary clinical endpoint of superiority versus vehicle plus standardized wound care and also did not show any meaningful difference in wound closure rate between the Locilex arm and the vehicle arm in each study. Neither trial met the secondary endpoint of demonstrating a higher rate of eradication of bacteria for the Locilex arm. While the overall adverse event incidence was comparable to vehicle alone, serious adverse events with Locilex included higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study.
David P. Luci, President & CEO of Dipexium, stated, "Although we are disappointed with these results, we are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible clinical indications based on an evaluation of all data emerging from the Phase 3 studies."
Benjamin A. Lipsky, MD, FACP, FIDSA, FRCP, Chair of the OneStep trials and lead author of the 2012 Infectious Disease Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections stated, "Speaking as Chairman of the OneStep trials, and on behalf of Warren Joseph, DPM, FIDSA, Co-Chair, we are certainly disappointed that we did not see a clear advantage to treating these patients with Mild DFI with Locilex cream. As diabetic foot infection is a complex problem, and this trial generated a great deal of data, we are currently reviewing the results to better interpret the outcome. I can, however, say that these pioneering studies were carefully designed and operationally well conducted. In over 30 years of conducting DFI clinical trials, I have not seen a more diligent or careful approach to ensuring patient safety and accurate data. The results of this study will provide important information regardless of the outcome. This will include a better understanding of the natural course of diabetic foot ulcer and infection, and a recognition that some Mild DFI patients may not need antibacterial treatment. The exemplary conduct of the trial reflects extremely well on the participating investigators. We look forward to continuing analyses of the wealth of data accumulated and to report more details of our findings."
Robert J. DeLuccia, Executive Chairman of Dipexium, emphasized, "The OneStep trials were the first ever 'placebo'-controlled studies conducted for mildly infected diabetic foot ulcers. In these studies, the 'placebo' was the cream vehicle without pexiganan, the active pharmaceutical ingredient in Locilex. These complex trials required stringent standardized wound care, in both study arms, including ulcer debridement, daily wound dressing changes and pressure off-loading devices. Since antibiotics are generally used by clinicians to treat an infected ulcer, no clinical trial in diabetic foot infection has ever established a 'response rate' for an ulcer infection that had standardized wound care but was untreated with an antibiotic."
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