ExThera Medical Achieves Promising Preliminary Safety And Efficacy Results In A Large-Animal Model

“We are excited to report that based on Phase II test results of Seraph 200, ExThera has been chosen to take part in the final Phase of the DARPA Dialysis-Like Therapeutics program, including preparation for an FDA IDE application,” said Robert Ward, CEO, ExThera.

BERKELEY, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, the leading developer of broad-spectrum, dialysis-like devices to treat bloodstream infections, disclosed today that it has been selected to participate in a Phase IV subcontract with the prime contractor for the U.S. Defense Advanced Research Projects Agency’s (DARPA) Dialysis-Like Therapeutics (DLT) program. During pilot Phase II in vivo testing of ExThera’s Seraph^® Microbind^® Affinity Blood Filter (Seraph), Seraph removed an average of 80±5% (n=4) of methicillin-resistant Staphylococcus aureus (MRSA) in a single pass through the Seraph device.

S. aureus and drug-resistant MRSA are the most common causes of infection in patients undergoing routine dialysis for kidney failure, and bloodstream infections are the second-most common cause of death in end-stage renal disease patients. Bloodstream infections are also a life-threatening complication in battlefield (IED blast) injuries because they can lead to septic shock with multiple organ failure. Initially Seraph will be used clinically for early treatment of bloodstream infections to prevent sepsis and reduce or eliminate ICU stays. Future clinical studies will treat patients whose bloodstream infections have already progressed to full-blown sepsis, and septic shock.

The Phase II in vivo performance of the Seraph 200 was very similar to earlier in vitro studies performed at independent laboratories in Europe and the USA. This suggests that bench studies can accurately predict performance in therapeutic uses of Seraph. Another important result of Phase II testing was the demonstrated safety of the Seraph 200 device. Twenty-three different parameters were monitored to determine if Seraph had any negative effects on the blood being treated. Not one of these parameters changed when Seraph was inserted into the dialysis circuit.

ExThera Medical was the first to report the removal of bacteria from whole blood using a device, instead of a drug. ExThera has also published confirmation of Seraph’s ability to remove 99.9% of two Carbapenem-Resistant Enterobacteriaceae (‘CRE Superbugs’) — E. coli and Klebsiella pneumoniae — from blood after only brief contact with the Seraph adsorption media. Study results are published in the online journal PLOS O N E .

Operation of Seraph is simple. It resembles a filter and is inserted into the blood flow circuit between the patient and an optional dialysis cartridge. Blood flows freely from the patient through Seraph and is returned to the patient. In a typical four-hour treatment the patient’s entire blood volume passes through Seraph and the dialyzer 10 to 15 times, reducing pathogen concentration with each pass to a level that may be undetectable…much more quickly than a typical antibiotic or antiviral drug. Seraph has the added advantages of binding drug-resistant bacteria and viruses, without inducing the release of their toxins in the process. Seraph can actually capture and remove toxins, e.g., those generated by dying bacteria when effective anti-infective drugs are available, possibly reducing patient recovery time.

Every year there are 1.8 million new cases of bloodstream infection in the U.S. and Europe, and though not all are drug resistant, they can cause patients serious complications and impose a high cost burden on health care systems. .

“Certain bloodstream infections have a mortality rate as high as 50% when treatment is delayed or unavailable. With fewer anti-infective drugs being developed, and the continuing emergence of drug- resistant pathogens, clinicians need new technologies to fight bloodstream infections. The very broad-spectrum binding capability of Seraph suggests that it might be used before identification of the offending organism, which often takes many hours. This would reduce costly delays that are known to increase complications and the chance of death,” said Bob Ward, CEO, ExThera Medical.

Seraph 100 is currently being evaluated in clinical trials as a totally unique broad-spectrum ‘hemoperfusion’ device. Seraph has demonstrated ability to bind and remove a long list of disease-causing agents from whole blood, including viruses, bacteria, fungi and inflammatory cytokines. Unlike other devices in early-stage development, Seraph is easily manufactured in large quantities from readily-available raw materials. Its use of ‘immobilized heparin’ (bound to small biocompatible microspheres) also gives Seraph excellent blood compatibility. In addition to the potential to treat bacterial and viral infections for the prevention of sepsis, Seraph is a flexible platform that could be configured with optional supplemental adsorbents to deal with other pathogens.

About ExThera Medical
Privately held ExThera Medical, based in Martinez, CA (@ Feb. 1, 2016) is targeting the prevention and treatment of blood-borne diseases including bacteremia and viremia. While medical treatments of, for example, bacteremia caused by S. aureus or MRSA (Methicillin-resistant S. aureus) usually rely on antibiotics, ExThera’s Seraph® 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 and toxin load, and the duration of bloodstream infections, thereby preventing complications such as endocarditis, osteomyelitis, and a runaway systemic inflammatory response. The Company will exhibit Seraph at the Society for Critical Care Medicine 45th Critical Care Congress, February 20-24, 2016, at the Orange County Convention Center, Orlando, Florida.

CAUTION: ExThera Medical’s Seraph® device is not cleared by the FDA for distribution in the United States.

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