Pharmaceuticals company Amedex Inc said on Thursday that it plans 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) under a collaboration agreement with Nassau based Foot and Ankle International (Bahamas), a podiatric medical and surgical group based in Nassau, The Bahamas.
This Phase 2 cDFU clinical trial of the proprietary gel formulation Nu-3 will commence in early 2019 under the direction of the prominent Bahamian surgeon, Dr Daniel Johnson, who is the principal and chief researcher of Foot and Ankle International (Bahamas).
Under the Phase 2 cDFU clinical trial, 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.
According to the company, 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 trials will 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. The company's lead product, Nu-3, is being developed as a treatment for bacterial and fungal infections, including DFU and oral mucositis.
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