A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Antimicrobial Efficacy Of Topically Once Or Twice Daily Applied Bisphosphocin® Nu-3 Gel At 5% And 10% Concentrations To Infected Diabetic Foot Ulcers (iDFU)

The goal of this clinical trial is to test a topical drug in patients with mild infections of their diabetic foot ulcer. The main questions it aims to answer are:
What strength does the drug need to be in order to make the infection better? How frequently does the drug need to be applied in order to make the infection better? Participants will be asked to apply the medicine on their foot ulcer twice a day for 2 weeks and remain off of that foot during that time.
Participants will receive the medication either once a day or twice a day, in either a 5% or 10% gel, or placebo.
Researchers will compare the 5% and 10% gels to placebo to see if the infection improves.

开始日期2024-12-01

申办/合作机构

Lakewood-Amedex, Inc.

NCT05276401 / Terminated临床2期

A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 Gel to Clinically Noninfected Chronic Diabetic Foot Ulcers (cDFU)

A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT ULCERS (cDFU)

开始日期2022-03-11

申办/合作机构

Lakewood-Amedex, Inc.

[+2]

NCT02737722 / Completed临床1/2期

A Phase I/IIa, Randomized Double Blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus

Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.

开始日期2016-04-01

申办/合作机构

Lakewood-Amedex, Inc.

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项与 Lakewood-Amedex, Inc. 相关的文献（医药）

2015-11-01·Future microbiology3区 · 生物学

Bisphosphocins: Novel Antimicrobials for Enhanced Killing of Drug-Resistant and Biofilm-Forming Bacteria

3区 · 生物学

Review

作者: Parkinson, Steve ; DiTullio, Paul ; Wong, Jonathan P

The global prevalence of antibiotic resistance and the threat posed by drug-resistant superbugs are a leading challenge confronting modern medicine in the 21st century. However, the progress on the development of novel antibiotics to combat this problem is severely lagging. A more concerted effort to develop novel therapeutic agents with robust activity and unique mechanisms of action will be needed to overcome the problem of drug resistance. Furthermore, biofilm forming bacteria are known to be increasingly resistant to the actions of antibiotics and are a leading cause of mortality or morbidity in nosocomial infections. Bisphosphocins (also scientifically known as nubiotics) are novel small protonated deoxynucleotide molecules, and exert their antibacterial activity by depolarization of the bacterial cell membrane, causing bacterial cell death. Bisphosphocins may represent an effective weapon against antibiotic-resistant and biofilm-forming pathogenic bacteria. Preclinical efficacy studies in animals have shown that the compounds are safe and, efficacious against various bacterial infections, including drug-resistant pathogens. In vitro biochemical analysis confirmed that the bactericidal activity of bisphosphocins is mediated by depolarization of the bacterial cell membrane, and these compounds are better able to penetrate through bacterial biofilm and kill the biofilm encased bacteria. This article will cover the structure, mode of action, safety, efficacy and the current state of development of bisphosphocins. Together, the information presented here will present a strong case for bisphosphocins to be considered for use as new weapons to complement the existing arsenal of antimicrobial drugs and as a first line defence against drug-resistant and biofilm-forming bacteria.

2008-06-01·Anti-inflammatory & anti-allergy agents in medicinal chemistry

Inhibition of Highly Pathogenic Avian H5N1 Influenza Virus Replication by NanoRNA Oligonucleotides

作者: Sun, Lun-Quan ; Dale, Rod ; Wang, Ming

A review.H5N1 avian influenza virus (AIV) has caused widespread infections in poultry and wild birds, and has the potential to emerge as a pandemic threat to human.Nucleic acid-based drugs are promising classes of therapeutic agents that have important clin. applications for the prevention and treatment of viral diseases.In this review, a brief overview is made in the use of antisense technol. in gene suppression.The main focus is on the features of a modified short RNA oligonucleotide (nanoRNAs) and its use in suppression of H5N1 influenza viral replication, including the design, efficacy of nanoRNAs and the evaluation of these agents from in vitro activity to efficacy in animal protection studies.

项与 Lakewood-Amedex, Inc. 相关的新闻（医药）

2023-11-01

·PRNewswire

Lakewood-Amedex Announces Leadership Changes

Peter B. Corr, Ph.D., Named Executive Chairman UNIVERSITY PARK, Fla., Nov. 1, 2023 /PRNewswire/ -- Lakewood-Amedex Inc., a privately held, clinical-stage pharmaceutical discovery and development company advancing a broad portfolio of first-in-class antimicrobial and antifungal therapeutics called Bisphosphocins™, today announced that Peter B. Corr, Ph.D., who has served as board chairman since 2020, was named Executive Chairman and will assume the strategic responsibilities of former CEO Steve Parkinson who left the company at the request of the Board. Dr. Corr is the Co-founder and Managing General Partner of Auven Therapeutics Management LLLP. He retired from Pfizer Inc. in 2006 where he was Senior Vice President for Science and Technology, in addition to leading worldwide pharmaceutical research and development for Pfizer. Previously, Dr. Corr served as Executive Vice President, Pfizer Global Research & Development and President, Pfizer Worldwide Development. His full CV is on the Lakewood-Amedex website The Company also announced leadership promotions in the organization for Thomas Balzer, M.D., Ph.D., Senior Vice President for Clinical Development, and Kelvin Cooper, Ph.D., Vice President of Research and Development. Both Dr. Balzer and Dr. Cooper now report to Dr. Corr. Dr. Balzer will take on the additional role of Chief Medical Officer, and Dr. Cooper, who will serve as Chief Operating Officer, was promoted to Senior Vice President of Research and Development. Dr. Balzer and Dr. Cooper now report to Dr. Corr Dr. Balzer is an accomplished healthcare professional with extensive experience in clinical drug development and medical affairs. In his most recent position, Dr. Balzer was Head of Clinical Development at Thrive Detect, an Exact Sciences Company, and was leading the development of a multi-cancer detection liquid biopsy assay. Dr. Balzer worked for more than 25 years in various positions at Bayer HealthCare and served as Vice President and Global Head of Medical Affairs & Clinical Development Radiology at Bayer U.S. in NJ with responsibility for Bayer's medical imaging business. This included pharmaceuticals (contrast media), medical devices, and informatics/ AI projects. Dr. Balzer also built, developed, and managed teams at different locations worldwide and completed four global clinical development programs/ NDAs as well as several additional indication expansions. Dr. Balzer attended medical school in Berlin, Germany, and conducted his residency at the Benjamin Franklin Hospital of the Free University Berlin. He is board-certified in Germany in Internal Medicine, and he earned his Ph.D. from the Free University for work in neuro-endocrine pharmacology. Dr. Cooper is a seasoned pharmaceutical scientist and executive with more than 45 years of experience in all aspects of drug discovery and development across several therapeutic areas including infectious disease, cancer, respiratory, immunology, and inflammation. Before joining Lakewood-Amedex, Dr. Cooper filled several roles at Pfizer, including Senior Vice President for Portfolio Development in its Established Pharmaceutical Sciences Business Unit; Senior Vice President of Worldwide Pharmaceutical Sciences with responsibility for both small molecules and biologics in the areas of drug substance, drug product, and device development; Executive Director of drug development for cancer, respiratory, allergy, immunology, and infectious disease; and Director of Drug Discovery in those same therapeutic areas. Dr. Cooper earned a Ph.D. in Organic Chemistry from the University of Nottingham and is a past recipient of the Captain Black Award for Science. He has also authored 46 publications and holds 34 patents. Board chairman Dr. Peter B. Corr stated, "We are fortunate to have Drs. Balzer and Cooper serve in these important roles at Lakewood-Amedex, and their promotions reflect the level of accomplishment that they have brought to the company during their tenure. We look forward to their continued contributions as we work to advance our Research and Clinical Development programs." About Lakewood-Amedex, Inc. Lakewood-Amedex is a privately held, clinical-stage pharmaceutical company developing a broad portfolio of first-in-class antimicrobial and antifungal therapeutics called Bisphosphocins™. The company's products and technology are covered by an extensive patent portfolio consisting of granted and/or issued patents and pending patent applications covering many major pharmaceutical indications. The company's lead therapeutic candidates are novel synthetic broad-spectrum antimicrobials proven to be effective in killing a wide range of Gram-positive, Gram-negative, and antibiotic-resistant bacteria and all fungal strains tested. Nu-3 has already completed a Phase 2 clinical trial in patients with infected diabetic foot ulcers and a larger Phase 2 program is being initiated. For more information, Contact: Tiberend Strategic Advisors, Inc. Media David Schemelia [email protected] 609-468-9325 SOURCE Lakewood-Amedex Inc.

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药物(靶点)	适应症	全球最高研发状态

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