Phase 3 Study of Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections Among Colorectal Surgery Patients (Triple IN Study --Inhibition of Incisional Infections)

This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being developed for direct application to a surgical incision.

Start Date10 Jan 2013

Sponsor / Collaborator

Excited States, LLC

[+4]

100 Clinical Results associated with E-101

100 Translational Medicine associated with E-101

100 Patents (Medical) associated with E-101

Literatures (Medical) associated with E-101

01 Jul 2019·Infection and Immunity

Mechanism of Microbicidal Action of E-101 Solution, a Myeloperoxidase-Mediated Antimicrobial, and Its Oxidative Products

Article

Author: Devoe, Neil C. ; Denys, Gerald A. ; May, Meghan ; Stephens, Jackson T. ; Allen, Robert C. ; Gudis, Polyxeni

E-101 solution is a first-in-class myeloperoxidase-mediated antimicrobial developed for topical application. It is composed of porcine myeloperoxidase (pMPO), glucose oxidase (GO), glucose, sodium chloride, and specific amino acids in an aqueous solution.

01 Aug 2014·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

Five-Year Longitudinal Assessment (2008 to 2012) of E-101 Solution Activity against Clinical Target and Antimicrobial-Resistant Pathogens

Q2 · MEDICINE

Article

Author: Pillar, Chris M. ; Sahm, Daniel F. ; Denys, Gerald A. ; Stephens, Jackson T. ; O'Hanley, Peter

ABSTRACTThis study summarizes the topical E-101 solution susceptibility testing results for 760 Gram-positive and Gram-negative target pathogens collected from 75 U.S. sites between 2008 and 2012 and 103 ESKAPE pathogens. E-101 solution maintained potent activity against all bacterial species studied for each year tested, with MICs ranging from <0.008 to 0.25 μg porcine myeloperoxidase (pMPO)/ml. These results confirm that E-101 solution retains its potent broad-spectrum activity against U.S. clinical isolates and organisms with challenging resistance phenotypes.

01 Jul 2011·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

In Vitro and In Vivo Activities of E-101 Solution against Acinetobacter baumannii Isolates from U.S. Military Personnel

Q2 · MEDICINE

Article

Author: Stephens, J. T. ; Denys, G. A. ; O'Hanley, P. D. ; Davis, J. C.

ABSTRACT We evaluated the in vitro and in vivo activity of a novel topical myeloperoxidase-mediated antimicrobial, E-101 solution, against 5 multidrug-resistant Acinetobacter baumannii isolates recovered from wounded American soldiers. Time-kill studies demonstrated rapid bactericidal activity against all A. baumannii strains tested in the presence of 3% blood. The in vitro bactericidal activity of E-101 solution against A. baumannii strains was confirmed in a full-thickness excision rat model. Additional in vivo studies appear warranted.

100 Deals associated with E-101

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Surgical Wound Infection	Phase 3	-	Exoxemis, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01297959 (Triple IN, CTgov)	Phase 3	Surgical Wound Infection	503	E-101 Solution 300 GU/ml (E-101 Solution 300 GU/mL)	fuqdlqrsnw(tamzozbkfb) = efmwpjbkxb rxonwvrpse (kmiossydvt, seokgatdau - uirmglxboe) View more	-	19 Jan 2021
				Saline solution (Placebo (Saline Solution))	fuqdlqrsnw(tamzozbkfb) = yvzazfgcrt rxonwvrpse (kmiossydvt, iiccklyikh - twqapcaslv) View more

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