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.

Start Date01 Dec 2024

Sponsor / Collaborator

Lakewood-Amedex, Inc.

NCT02737722 / CompletedPhase 1/2

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.

Start Date01 Apr 2016

Sponsor / Collaborator

Lakewood-Amedex, Inc.

100 Clinical Results associated with Bisphosphocin Nu3

100 Translational Medicine associated with Bisphosphocin Nu3

100 Patents (Medical) associated with Bisphosphocin Nu3

Literatures (Medical) associated with Bisphosphocin Nu3

01 Jan 2011·Annals of clinical microbiology and antimicrobialsQ3 · MEDICINE

Antimicrobial activity and mechanism of action of Nu-3, a protonated modified nucleotide

Q3 · MEDICINE

ArticleOA

Author: Shanping Cao ; Ming Wang ; Lun-Quan Sun

Abstract:

Background:

"Nubiotics" are synthetic oligonucleotides and nucleotides with nuclease-resistant backbones, and are fully protonated for enhanced ability to be taken up by bacterial cells. Nu-3 [butyl-phosphate-5'-thymidine-3'-phosphate-butyl], one of the family members of Nubiotics was efficacious in the treatment of burn-wound infections by Pseudomonas aeruginosa in mice. Subsequent studies revealed that Nu-3 had a favorable toxicological profile for use as a pharmaceutical agent. This study evaluated the antibacterial activity of Nu-3 in vitro and its efficacy as a topical antibiotic. In addition, we investigated the possible mechanisms of Nu-3 action at the levels of DNA synthesis and bacterial membrane changes.

Methods:

Antimicrobial minimum inhibitory concentrations (MIC) experiments with Nu-3 and controls were measured against a range of Gram-positive and Gram-negative bacteria, including some hospital isolates according to Clinical and Laboratory Standards Institute (CLSI) guidelines. Analysis of the killing kinetics of Nu-3 was also performed against two strains (Staphylococcus aureus cvcc 2248 and Pseudomonas aeruginosa cvcc 5668). The mouse skin suture-wound infection model was used to evaluate the antibacterial activity of Nu-3. We used a 5-Bromo-2'-deoxy-uridine Labeling and Detection Kit III (Roche, Switzerland) to analyze DNA replication in bacteria according to the manufacturer's instruction. The BacLight™ Bacterial Membrane Potential Kit (Invitrogen) was used to measure the bacterial membrane potential in S. aureus.

Results:

Nu-3 had a wide antibacterial spectrum to Gram-positive, Gram-negative and some resistant bacteria. The MIC values of Nu-3 against all tested MRSA and MSSA were roughly in a same range while MICs of Oxacillin and Vancomycin varied between the bacteria tested. In the mouse model of skin wound infection study, the treatment with 5% Nu-3 glycerine solution also showed comparable therapeutic effects to Ciprofloxacin Hydrochloride Ointment. While Nu-3 had no effect on DNA synthesis of the tested bacteria as demonstrated in a BrdU assay, it could cause bacterial cell membrane depolarization, as measured using a BacLight™ Bacterial Membrane Potential Kit.

Conclusions:

These results provide additional experimental data that are consistent with the hypothesis that Nu-3 represents a new class of antibacterial agents for treating topical infections and acts via a different mechanism from conventional antibiotics.

01 Jan 2010·Journal of biomedicine & biotechnology

Acute, Multiple-Dose Dermal and Genetic Toxicity of Nu-3: A Novel Antimicrobial Agent

Article

Author: Wang, Ming ; Sun, Lun-Quan ; Cao, Shanping ; Zhang, Guozhong ; Sun, Juan ; Hu, Yanxin

Nu-3 [butyl-phosphate--thymidine--phosphate-butyl] is a modified nucleotide that has been shown to have antimicrobial activity against a range of bacteria includingPseudomonas aeruginosa. However, data on the toxicological profile of Nu-3 are still lacking. In the present study, the toxicity of Nu-3 was evaluated by the following studies: acute oral toxicity, dermal and mucous membrane irritation, multiple-dose toxicity and genotoxicity in vivo and vitro. The acute oral toxicity test in mice showed that Nu-3 had an of 2001mg/kg body weight. The irritation tests on rats revealed that Nu-3 was not irritant, with an irritation scoring of 0. The multiple-dose toxicity study in rats showed that Nu-3 did not cause significant changes in histology, selected serum chemistry, and hematological parameters compared to the controls. Rats administrated with multiple-doses of Nu-3 showed no visible toxic symptoms. Both in vitro and in vivo, Nu-3 exhibited no notable genetic toxicity. Overall, the data suggest that Nu-3 is hypotoxic or nontoxic antimicrobial compound that warrants being further developed for treatingPseudomonas aeruginosainfection.

01 Aug 2004·Antimicrobial agents and chemotherapyQ2 · MEDICINE

Therapeutic Efficacy of “Nubiotics” against Burn Wound Infection by Pseudomonas aeruginosa

Q2 · MEDICINE

Article

Author: Wong, Jonathan P. ; Schnell, Glen ; Dale, Roderic M. K.

ABSTRACT:

“Nubiotics” are a novel class of proprietary protonated nucleic acid-based drugs shown to have potent in vitro antibacterial activities against a number of gram-positive and gram-negative bacteria. These nubiotics are evaluated here for their in vivo therapeutic efficacy for the treatment of burn wound infection caused by Pseudomonas aeruginosa . To achieve this, a burn wound infection model was established in mice by using a highly pathogenic burn wound clinical isolate of P. aeruginosa . Lethal doses of the bacteria were determined for two routes of infection (subcutaneous and topical), representing systemic and local forms of infection, respectively. Using this infection model, treatment with nubiotics by various routes of drug administration was evaluated and optimized. A total of 12 nubiotics and their analogues were tested and of these, Nu-2, -3, -4, and -5 were found to be extremely efficacious in the postexposure treatment of burn wound infection (60 to 100% survival rates versus 0% for untreated control [ P < 0.05]). These nubiotics were effective when given either systemically by intravenous and/or subcutaneous administration or given locally to the affected site in the skin by topical application. Treatment by these two routes resulted in almost 100% survival rates and complete eradication of the bacteria from infection sites in the livers, spleens, and blood. These nubiotics were found to be as effective as intravenously administered ciprofloxacin, a potent and broad-spectrum fluoroquinolone. These results suggest that nubiotics may be a promising and effective approach for the treatment of burn wound infection caused by P. aeruginosa .

News (Medical) associated with Bisphosphocin Nu3

01 Nov 2023

·www.prnewswire.com

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.

Executive ChangePhase 2

100 Deals associated with Bisphosphocin Nu3

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic foot ulcer	Phase 2	US	Lakewood-Amedex, Inc.	11 Mar 2022
Diabetic foot infection	Phase 2	US	Lakewood-Amedex, Inc.	01 Apr 2016
Diabetic ulcer	Phase 2	US	Lakewood-Amedex, Inc.	01 Apr 2016
Burn infections	Preclinical	US	Lakewood-Amedex, Inc.	-
Lung Diseases	Preclinical	US	Lakewood-Amedex, Inc.	-
Onychomycosis	Preclinical	US	Lakewood-Amedex, Inc.	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02737722 (CTgov)	Phase 1/2	Diabetic foot infection \| Diabetic ulcer	31	Placebo	fojqsubsaf(iymhhuhthi) = jjpfnkdbsy uwdjrghttz (hoeaxbfglo, vzcbkcuhdg - kngciopheo) View more	-	19 Nov 2019

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