Jan. 17, 2019 – Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced today it had entered into a collaboration agreement with Nassau based Foot and Ankle International (Bahamas) to conduct two Phase 2 cDFU clinical trial for its topically applied Nu-3 antimicrobial used to eliminate infection and promote wound healing in patients with chronic diabetic foot ulcers (cDFU). The trial will be under the direction of the prominent Bahamian surgeon, Dr. Daniel Johnson, who is the principal and chief researcher of Foot and Ankle International (Bahamas). He is an acknowledged expert on the treatment of diabetic foot ulcers.
Nu-3, which belongs to a proprietary class of antimicrobials called Bisphosphocins™, was first used as a solution to treat infected diabetic foot ulcers for seven days in a Phase 1/2 a clinical trial completed late 2017, when it was well-tolerated with no reported adverse events related to treatment. Results showed promising trends with median wound area reduction (change from baseline) of 65.5% in the 2% Nu-3 treatment arm, versus 29.9% in the placebo arm.
Lakewood-Amedex, based in Sarasota, Florida, has developed a proprietary gel formulation of Nu-3, said they intend to conduct a Phase 2 clinical trial commencing early 2019 using this compound to treat chronic diabetic foot ulcers (cDFU), with a 28-day treatment period using escalating concentrations of Nu-3. The company believes this longer treatment with increased Nu-3 concentration will improve the potential to reach a point of healing or partial healing of the patient’s ulcers. Lake-Amedex also intends to conduct an ‘adaptive arm’ of this clinical trial which will involve treating an increased number of patients with the most effective concentration of the gel formulation to achieve robust clinical data.
Steve Parkinson, President and CEO of Lakewood-Amedex, said the company will seek to recruit up to 120 patients for the entire clinical trial and has identified the Bahamas as not only an up and coming location for medical specialty in DFU in the treatment of diabetic foot wounds and ulcers, but also a potential source of large numbers of patients.
Dr. Daniel Johnson, who recently hosted the First International Congress, “New Hope For The Diabetic Foot, Solving the problem for The Bahamas and the region,” said that both companies had agreed that the Bahamas was an ideal clinical site for the proposed trial.
In making the announcement, Mr. Parkinson said, “We are thrilled to be working with such a prestigious physician in the DFU specialty as Dr. Johnson who will add immeasurably to our project in the Bahamas.”
Dr. Johnson said, his group was excited to be collaborating with Lakewood-Amedex. “Physicians and surgeons everywhere are anxious to find potential new therapeutics that might be used to treat chronic ulcers which often results in problems for millions of patients around the world. It entails significant healthcare costs and ultimately may result in the amputation of limbs with all the issues, hospitalization and rehabilitation that goes with it. We believe that Bisphosphocin technology may provide new resources to solve these problems, save suffering and save millions of dollars in healthcare costs.”
He said the trials will also serve to focus attention on the growing role of the Bahamasas a center of excellence for the research and treatment of numerous medical conditions. “We have been at the very forefront of research, diagnosis and treatment of diabetic foot conditions for the past 25 years,” he said.