Chronic diabetic foot ulcer phase two clinical trial to be conducted in The Bahamas
Bahamian foot surgeon Dr. Daniel “Danny” Johnson, has signed on to be the lead researcher for phase two of a chronic diabetic foot ulcer (cDFU) clinical trial for a topically applied Nu-3 antimicrobial used to eliminate infection and promote wound healing in patients. The trial will be under the direction of Johnson who is the principal and chief researcher of Foot and Ankle International (Bahamas), and an expert on the treatment of diabetic foot ulcers.
U.S.-based Lakewood-Amedex Inc., a privately held, clinical stage biopharmaceutical company, has entered into a collaboration agreement with Nassau-based Foot and Ankle International (Bahamas), a podiatric medical and surgical group that has been at the front line of the diagnosis and treatment of the diabetic foot for over 25 years, to conduct the research and development project to bring the crisis of diabetic foot amputations worldwide under control.
With a successful phase one in the U.S., and before global representation, phase two has been signed on for The Bahamas with Dr. Johnson as the lead researcher. Johnson said phase two has sparked the interest of the diabetic foot centers of the Americas and places The Bahamas as a regional center of excellence; and for Johnson to become a fixture on the global team of Lakewood-Amedex pharmaceutical.
According to Lakewood-Amedex, 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. The pharmaceutical company said results showed promising trends with median wound area reduction (change from baseline) of 65.5 percent in the two percent Nu-3 treatment arm, versus 29.9 percent in the placebo arm.
Lakewood-Amedex, based in Sarasota, Florida, has developed a proprietary gel formulation of Nu-3, and said they intend to conduct a Phase 2 clinical trial commencing early this year using the compound to treat cDFU, with a 28-day treatment period using escalating concentrations of Nu-3. The company believes the 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 (diabetic foot ulcers) in the treatment of diabetic foot wounds and ulcers, but also a potential source of large numbers of patients.
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.
“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,” said Parkinson in making the announcement.
Johnson said, his group was excited to be collaborating with
“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,” said Johnson who is also president of the Bahamas Podiatric Medical Association.
It is the goal of Johnson and his colleagues to establish the Bahamas Foot and Ankle International as a regional center of excellence in the field of podiatric medical and surgical services. He said they strive to bring the best in global research development and treatment of diabetic foot complications especially in the Caribbean, a region of the world most impacted by this healthcare crisis – and that their constant aim is to see a significant reduction in lower extremity amputations and improve people’s quality of life and health.
Johnson said the trials will also serve to focus attention on the growing role of The Bahamas as 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,” said Johnson.