Lakewood-Amedex, Inc. announced today that it has commenced its second Phase 2 study using Bisphosphocin Nu-3 antimicrobial in treating patients with diabetic foot ulcers (DFU). More than 34 million adults in the United States have diabetes mellitus (Source: CDC), and complications of DFU are responsible for about 85% of the non-traumatic lower extremity amputations per year, creating a tremendous morbidity, mortality, and financial burden on the healthcare system.
The Phase 2 study is a randomized, multi-center, double-blind, placebo-controlled, dose-escalating study to evaluate the safety and tolerability of topically applied Bisphosphocin Nu-3 gel on Type I or II diabetes mellitus patients with chronic DFU. During all clinic visits, the patients’ ulcers will be examined for any changes in the area and depth of the ulcer and microbiological control will be assessed.
Steve Parkinson, President & CEO of Lakewood-Amedex, said, “We are very pleased to be embarking upon our second clinical trial in treating DFUs. In our previous experience evaluating Nu-3 for the treatment of patients with infected diabetic foot ulcers, Nu-3 was well-tolerated with no reported adverse events related to treatment. While this previous dose-escalating study was not powered to generate statistically significant efficacy data, it did demonstrate an encouraging efficacy trend. Patients treated with 2% Nu-3 solution for seven days had a 65.5% reduction in ulcer area versus a 29.9% reduction in the placebo arm, as measured 14 days after treatment began. In addition, 62.5% of patients treated with 2% Nu-3 saw a reduction in the microbiological load, versus 20% in the placebo. Now our Phase 2 dose-escalating study will build on the foundation of the previous clinical trials by using a longer treatment duration of 28 days, a higher concentration of 5% followed by 10% Nu-3, as well as an improved Nu-3 gel formulation, all of which we expect will offer a better delivery of Nu-3 and treatment of nonhealing wounds. The impact of both topical and systemic infections remains a tremendous burden on the healthcare system. We believe our commitment to further developing our proprietary, antimicrobial Bisphosphocins technology platform with efficient, localized treatment of serious infections, often caused by antibiotic-resistant pathogens, both gram-positive and gram-negative, will enable healthcare providers to more safely and effectively address a host of bacterial infections that are currently proving challenging using conventional approaches.”
“Dr. Felix Sigal, who is one of the most distinguished specialists in the field of diabetic limb salvage, is on staff at both the Hollywood Presbyterian Medical Center and the California Hospital Medical Center. He focuses on wound care and diabetic limb salvage, while pursuing his interest in clinical research to enable better treatment options for his patients. We are pleased to report that Dr. Sigal has now enrolled the first patient in this Phase 2 study evaluating the use of Nu-3 gel in the treatment of diabetic foot ulcers,” said Sumita Paul, MD, MPH, MBA, Chief Medical Officer & Senior Vice President of Research & Development at Lakewood-Amedex Inc. “There will be 12 patients treated with the Nu-3 gel in each of the two cohorts and with a smaller placebo treated group.”