Lakewood-Amedex Prepares To Launch A Phase 2 cDFU Clinical Trial for Its Nu-3 Antimicrobial In The Bahamas
SARASOTA, Fla., Jan. 17, 2019 /PRNewswire/ -- 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 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," he said.
About Lakewood-Amedex, Inc.
Lakewood-Amedex is a privately held, clinical stage biopharmaceutical company developing a broad portfolio of innovative, novel-approach, anti-infective products in the treatment of serious infectious diseases, improving patient outcomes and significantly reducing the threat posed by antibiotic-resistant bacterial strains like MRSA, VRE, NDM-1, and biofilm strains. The Company's Bisphosphocin products and technology are covered by an extensive patent portfolio consisting of 28 issued and 6 pending patents. The Company's lead product, Nu-3, a first-in-class antimicrobial now in clinical trials, is being developed as a treatment for bacterial and fungal infections, including DFU and oral mucositis.
About Foot and Ankle International (Bahamas).
The Bahamas Foot and Ankle International is a podiatric medical and surgical group based in Nassau, The Bahamas. It has been at the front line of the diagnosis and treatment of the diabetic foot for over 25 years. Lead Researcher, Dr. Daniel Johnson, has worked for decades in the field of diabetic wounds and ulcers in Canada and the U.K. He is President of the Bahamas Podiatric Medical Association. The goal of Dr. Johnson and his colleagues is to establish the Bahamas Foot and Ankle International as a regional center of excellence in the field of podiatric medical and surgical services. They strive to bring the very 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. Their constant aim is to see a significant reduction in Lower Extremity Amputations and improve people's quality of life and health. Thus, Dr. Johnson and his colleagues are pleased to introduce a new class of antimicrobial called, Bisphosphocins, to the healthcare equation and we are delighted with the introduction of this new formula, Nu-3, which has shown tremendous progress in the treatment of diabetic foot ulceration.
This press release contains forward-looking statements that can be identified by terminology such as "expects", "potential", "suggests", "may", "will" or similar expressions. Such forward-looking statements regarding our business, which are not historical facts, are "forward-looking statements" that involve risk and uncertainties, which could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. Actual results may differ materially from statements made as a result of various factors, including, but not limited to sufficiency of cash to fund the Company's planned operations, risk associated with inherent uncertainty of product research and development, risk of protecting proprietary rights and competition. Forward-looking statements speak only as to the date they are made. The Company does not undertake to update forward-looking statements to reflect the circumstances or events that occur after the date the forward-looking statements are made.
Steve Parkinson, President & CEO
Marston Webb International
T: (941) 359-0510 / 225 5859
T: (212) 684-6601 C: (917) 887-0418
Dr. Daniel Johnson
Foot and Ankle International
T: (242) 322-5402