Pexiganan Acetate

October 25, 2016 By Alex Keown , BioSpace.com Breaking News Staff NEW YORK – Shares of Dipexium are down more than 80 percent this morning after the company announced its Phase III topical cream Locilex for mild diabetic foot ulcers failed to meet its primary endpoint compared to standardized wound care in two clinical trials. Additionally, the New York-based company said Locilex, which has the active pharmaceutical ingredient pexiganan, failed to show any meaningful difference in wound closure rate during the OneStep-1 and OneStep-2 clinical trials. The experimental cream also failed its secondary trial endpoint of demonstrating a higher rate of eradication of bacteria than the standard of care. Not only did the treatment fail to reach its primary and secondary endpoints, but there were also serious adverse events with Locilex, including higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study, Dipexium said in a statement. Robert DeLuccia , Dipexium’s executive chairman of the board of directors, said the Locilex trials “were the first ever ‘placebo'-controlled studies conducted for mildly infected diabetic foot ulcers.” DeLuccia said the trials required stringent standardized wound care, 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,” DeLuccia said in a statement. Despite the failures, the company said it will analyze all trial data to determine if there is a pathway for regulatory approval in “other possible clinical indications based on an evaluation of all data emerging from the Phase III studies.” While the trials may not have achieved its endpoints, Benjamin Lipsky , the chairman of the two trials, hailed the trials for the amounts of “accurate data” the trials revealed. “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,” Lipsky said. If untreated diabetic foot ulcers can be a factor in amputations in diabetic patients. Some patients who experience foot ulcers may not know they are there because of nerve or blood vessel damage. Treatments for diabetic foot ulcers can include hemorheologic agents and antiplatelet agents. Smith & Nephew, Inc. ’s Regranex , a topical gel, for the treatment of diabetic foot ulcers, has been on the market since 1997. Dipexium is certainly not the first company to see its treatment for diabetic foot ulcers fail a clinical trial. Last year, Derma Sciences cratered after its only clinical candidate, aclerastide , proved ineffective. The trial was halted following a third-party assessment by a Data Monitoring Committee. Shares of Dipexium are trading at $2.37 as of 10:54 a.m., down from Monday’s close of $12.30 per share.