11 Dec Lakewood-Amedex Submits Investigational New Drug Application for Bisphosphocin™ Nu-3 for the Treatment of Diabetic Foot Infections
SARASOTA, Fla., Dec. 11, 2014 /PRNewswire/ — Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced that the Company has submitted an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to conduct a Phase 1/2a study of Nu-3 as a topical antimicrobial treatment for diabetic foot infections. Pending the FDA’s acceptance, the Phase 1/2a is designed to test the safety and tolerability of increasing doses of Nu-3 when applied topically as well as collect data on the changes in the microbiology of the ulcer over the course of treatment. The study is planned to begin early in 2015.
Paul DiTullio, Vice President, Product Development remarked, “This IND submission represents a major development milestone for our Bisphosphocin™ program. Our lead candidate, designated Nu-3, is the first in a novel class of synthetic broad spectrum antimicrobials that the Company is developing to address the growing unmet medical need in the antibiotic field. Bisphosphocins™ with their unique mechanism of action are particularly well suited for treating infected diabetic foot ulcers as these infections tend to be caused by both gram positive and gram negative bacteria and involve biofilm.”
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 products and technology are covered by an extensive patent portfolio consisting of 74 issued and 13 pending patents. The Company’s lead product, Nu-3, a first-in-class antimicrobial, is being developed as a treatment for bacterial and fungal infections. Lakewood-Amedex is also developing orally available ‘gene silencing’ nRNA therapeutics for the treatment of various viral indications, oncology applications, inflammatory conditions and other chronic human diseases.
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