Arkansas native Jackson T. “Steve” Stephens has published a new peer-reviewed article touting the benefits a new treatment for sepsis. Stephens is the founder and CEO of Exoxemis, a biomedical research company that focuses on the development of a “biological antiseptic system.
The new article, “Myeloperoxidase and Eosinophil Peroxidase Inhibit Endotoxin Activity and Increase Mouse Survival in a Lipopolysaccharide Lethal Dose 90% Model,” has been published in the Journal of Immunology Research.
According to Stephens, the research supporting the paper indicates that Exoxemis’ signature product Zempia provides protection against toxins that cause sepsis. According to the Centers for Disease Control, more than 1.7 million adults develop sepsis annually in the United States with 270,000 individuals dying as a result of sepsis. Zempia is the Exoxemis’ trade name for its “topical biological antiseptic system utilizing Myeloperoxidase (MPO),” according to the company website.
“This is a ground breaking study relative to the further investigation and testing of Zempia®, our trade name for myeloperoxidase (MPO), to combat sepsis,” Stephens said in a statement. “Our study utilized the Limulus amebocyte lysate (LAL) test which is the definitive test recognized by the FDA with regard to detecting endotoxins. Additionally, the mouse lethal dose 90% (LD90) survival model testing provided ‘unquestionably significant’ in-vivo data that demonstrated MPO increased survival in mice administered MPO with an otherwise lethal dose of endotoxin.”
According to Steven Weintz, vice president of communications and business development at Exoxemis, the company is planning to partner with a pharmaceutical or medical device company to perform additional testing and to obtain the regulatory approval necessary to bring Zempia to the market. He says the company is making an exclusive licensing agreement available for “further study and testing.
The company has already completed multiple human clinical trials with the treatment, including three Phase I and one Phase III trials across 25 sites in the United States and five sites in Israel. According to the Food and Drug Administration, a Phase I trial involves 20 to 100 healthy volunteers with a disease or condition that is designed to test a drug’s safety and dosage. This phase can last several months. A Phase III trial involves significantly more participants – from 300 to 3,000 volunteers and can last 1 to 4 years. It is designed to last 1 to 4 years.
In an email, Weitz said that laboratory and animal testing have produced evidence that Zempia is capable of killing antibiotic resistant bacteria, gram-negative and gram-positive bacteria, viruses, spores, yeast and fungi. In addition, he says that testing indicates that Zempia does not harm tissues or blood cells and does not cause “local irritation or sensitization.”
The full research paper can be read here.