22 Aug Lakewood-Amedex Inc. Completes Clinical Trial Recruitment for Final Cohort of the Company’s Phase 1/2a Program in Patients with Infected Diabetic Foot Ulcers
Top Line Results Expected in September 2017
SARASOTA, Fla., Aug. 22, 2017 /PRNewswire/ — Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced today the completion of patient treatment in the final cohort of the Company’s Phase 1/2a clinical trial for its lead program, topically applied Bisphosphocin Nu-3 antimicrobial, for patients with infected diabetic foot ulcers (DFU). The study, which enrolled three cohorts of ten patients each, is expected to report ‘top line’ data by the end of September 2017.
“Although this remains a blinded study, we are hopeful that the top line data in this Phase 1/2a study for Nu-3 will show similar results to our pre-clinical in vivo studies” said Steve Parkinson, President and CEO of Lakewood-Amedex. “The impact of both topical and systemic infections remains a tremendous burden on the healthcare system as a whole. 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 strains that are currently proving challenging using conventional approaches.”
The Phase 1/2a study for Nu-3 is a randomized, multi-center, double-blind, placebo-controlled, dose-escalating study to evaluate the safety and tolerability of topically applied Bisphosphocin Nu-3 on Type I or II diabetes mellitus patients with infected DFU. During all clinic visits, the patients’ ulcers were visually examined for any changes and photographed using the Aranz Medical Silhouette™ system to calculate area and depth of the ulcer.
Today, the vast majority of available antibiotics developed only slow or stall bacterial growth, which requires a well-functioning immune system to ultimately combat the infection. This significantly limits treatment options for immune-compromised patients. Alternatively, other antibiotic therapies have been found to be quite toxic. However, in pre-clinical studies Bisphosphocin-based therapies have been shown to be both extremely safe to mammalian cells while disrupting the bacterial cell membranes for more than 70 different types of bacterial pathogens, including antibiotic resistant strains. As such, Bisphosphocins may offer many clinically significant advantages over conventional antibiotics including the rapidity with which they depopulate the infection site.
About Lakewood-Amedex, Inc.
Lakewood-Amedex is a clinical stage pharmaceutical company developing a broad portfolio of anti-infective products, including first-in-class anti-bacterial compounds. The Company’s products and technology are covered by an extensive patent portfolio consisting of 74 granted and/or issued patents and 13 pending patent applications covering many major pharmaceutical markets. The Company’s lead therapeutic candidate is a novel synthetic broad spectrum anti-bacterial proven to be effective in killing a wide range of gram-positive, gram-negative and antibiotic-resistant bacteria and is currently completing a Phase 1/2a clinical trial.
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.