Results disclosed in Dec. 3, 2014, issue of online journal PLOS ONE
“We have developed a powerful new tool to answer worldwide concern over drug-resistant infectious diseases.” Robert Ward, CEO
BERKELEY, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, a pioneer in the development of broad-spectrum, dialysis-like therapeutic devices to treat life-threatening bloodstream infections, disclosed today that its Seraph® Microbind® Affinity Blood Filter (Seraph) removed 99.9% of two Carbapenem-Resistant Enterobacteriaceae (‘CRE Superbugs’) — E. coli and Klebsiella pneumonia — from blood samples spiked with the bacteria in just brief contact with the Seraph adsorption media. Study results are published in the online journal PLOS ONE.
Carbapenems are a group of antibiotics that had broad-spectrum activity when first introduced. In fact, they were developed to replace antibiotics that lost effectiveness due to the emergence of bacteria that produce ‘lactamases’, enzymes that protect bacteria against the large class of ß-lactam antibiotics that includes penicillin and cephalosporin. Although carbapenems are currently considered antibiotics of last resort, it is now clear that bacteria are evolving to become resistant to even this newer class of anti-infective drugs.
Every year there are 1.8 million new cases of bloodstream infection in the U.S. and Europe, causing patients serious complications and imposing a high cost burden on health care systems. Not all are drug-resistant. However, an outbreak of CRE infections of unknown origin even occurred in the National Institutes of Health Hospital in Bethesda, and was the subject of the Frontline Documentary “Hunting the Nightmare Bacteria.” Click here: “Hunting the Nightmare Bacteria”, FRONTLINE, PBS)
“CRE bloodstream infections have an average mortality rate of 50% due to the total lack of effective antibiotics. With fewer anti-infective drugs being developed, and the continuing emergence of drug-resistant pathogens, clinicians need new tools to fight bloodstream infections,” said Bob Ward, CEO, ExThera Medical.
Since 2008, privately funded ExThera (short for Extracorporeal Therapy) has been developing these tools. ExThera’s Seraph® Microbind® Affinity Blood Filter (Seraph), now fully developed and about to enter clinical trials, is a broad-spectrum ‘hemoperfusion’ device with demonstrated ability to bind and remove a long list of disease-causing agents. These include viruses, bacteria, fungi and inflammatory cytokines.
According to Dr. Keith McCrea, CTO of ExThera, “Since its inception ExThera’s mission has been to offer simple, device-based therapies for rapid treatment of a broad spectrum of bloodstream infections—including those caused by agents for which there are no effective therapeutic drugs. We are very pleased to report our results against two often deadly bacteria, so-called ‘CRE Superbugs’. After only brief contact with our adsorption media 99.9% of both (CRE) E. coli and (CRE) Klebsiella pneumonia were removed from blood samples spiked with the bacteria. In addition, we measured the total binding capacity of our Seraph device for these pathogens and found it to be very high, exceeding the entire bloodstream load in bacteremic patients.”
Seraph uses a biomimetic ‘adsorption media’ that includes chemically bound heparin and supplemental adsorbent materials in a simple flow-through cartridge. The well-known blood-thinning or anti-thrombogenic property of heparin contributes to the safety of the device, especially in situations when it must be used without systemic blood thinners.
Seraph is the only device reported to remove both bacteria and viruses directly from whole blood without adding anything to the blood being treated. It therefore has the potential to treat ‘polymicrobial’ infections seen in critically ill and/or immuno-compromised patients.
In addition to the potential to treat viral and bacterial bloodstream infections for the prevention of sepsis, Seraph is a flexible platform that may be configured with optional supplemental adsorbents to deal with future ‘weaponized’, or naturally-evolved, pathogens.
About ExThera Medical
Privately held ExThera Medical, based in Berkeley, Calif., is targeting the clinical treatment of blood-borne diseases including bacteremia and viremia, as well as the removal of harmful substances present in banked human blood. While medical treatments of e.g., bacteremia caused by S. aureus or MRSA (Methicillin-Resistant S. aureus) usually rely on antibiotics, ExThera Medical’s Seraph® device capitalizes on the pathogen’s affinity to attach to immobilized heparin, a natural anticoagulant which has many other biological attributes. Seraph® is designed to be a biomimetic adjunct or alternative to anti-infective therapy for reducing pathogen load, and the duration of bloodstream infections, thereby preventing complications such as endocarditis, osteomyelitis, and a runaway systemic inflammatory response. The Company introduced its Seraph device concept to clinicians earlier this year at the annual congress of the Society for Critical Care Medicine.
CAUTION: ExThera Medical’s Seraph® device is not cleared by the FDA for distribution in the United States.
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