February 2, 2021
Bethesda, MD - Today, The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) announced a cooperative agreement with the Uniformed Services University of the Health Sciences (USU) to work with a multi-disciplinary team developing clinical management guidelines for treating COVID-19 patients. The agreement, awarded in September 2020, also includes USU’s The American Genome Center (TAGC) as well as the Austere Environments Consortium for Enhanced Sepsis Outcomes (ACESO), a research consortium administered by HJF.
The agreement expands on the Defense Advanced Research Projects Agency’s $150 million research program into a pathogen agnostic extracorporeal blood cleansing medical countermeasure capable of responding to any infectious outbreak by conducting a clinical trial assessing blood purification using ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) and BOATM Biomedical’s GARNET™ device as a treatment for COVID-19. The agreement is a result of the Defense Health Agency (DHA) approving US Army Colonel and Chair of the USU Department of Medicine Dr. Kevin Chung’s proposed DoD COVID RESPONSE (Rapid Evaluation and Study of the Pandemic Outbreak Nationally by Sustaining and leveraging prolonged field care research Efforts) Consortium. Chung is the Principal Investigator on this new study.
This study builds upon data generated from Dr. Chung’s oversight of two patients who received ExThera’s Seraph® 100 therapy in April 2020, and the over 175 patients who have been treated across the US under FDA’s Emergency Use Authorization (EUA) since that time. The agreement expands the trial to further research therapeutic effectiveness and impact and is designed to take advantage of USU’s unique nationwide faculty and campus.
The Director of ACESO, HJF employee Danielle Clark, Ph.D., will serve as an Associate Investigator on this new consortium. Together, Chung and Clark will lead clinical evaluation of pathogen agnostic, extracorporeal source control techniques for sepsis along with the manufacturers of the devices, ExThera Medical of California and BOA Biomedical, Inc. of Boston.
“ACESO specializes in utilizing biomarkers to anticipate the likelihood of severe infection,” said Clark. “We are proud to apply our expertise to support this crucial work.”
ACESO researchers are performing in-depth biomarker analysis on patients across the complete spectrum of COVID-19 care, from asymptomatic to critically-ill individuals.
BOA’s technology has been shown to capture more than 100 clinically relevant pathogens across bacteria, fungi, parasites, viruses (including SARS-CoV-2) and toxins in the laboratory. This technology also addresses the growing emergence of antibiotic-resistant bacteria, and thus sepsis, which existing therapies cannot combat. The product is currently being tested in a FDA approved clinical trial for use in chronic hemodialysis patients with a suspected or confirmed bloodstream infection. In this study, it is intended to adsorb both live pathogens and pathogen-derived materials, including PAMPS, from circulating blood in patients with a bloodstream infection. This clinical experience can be leveraged to the situation with SARS-CoV-2.
Seraph® 100 was developed to rapidly and safely remove a broad spectrum of pathogens and sepsis mediators from blood to address the ongoing drug resistance crisis and pandemics (e.g. COVID-19). It is commercially available under European CE mark and US EUA and has been successfully used to treat bacterial, viral, and fungal bloodstream infections since 2019.
This project is sponsored by USU; however, the information or content and conclusions do not necessarily represent the official position or policy of, nor should any official endorsement be inferred on the part of, USU, the Department of Defense, or the U.S. Government.
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global nonprofit that administers more than $500 million in medical research funds annually. For more than 35 years, HJF has partnered with researchers and clinicians to provide bench to beside to battlefield research support. More than 3,000 HJF teammates ensure HJF is a trusted and responsive partner by providing scientific, administrative and program operations services to researchers in the military, academia, and private industry. For more information, visit hjf.org.
About ExThera Medical
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration therapies, including the Seraph 100 Microbind Affinity Blood Filter for removing a broad range of harmful substances from the blood in a broad area of care: Hospitals, clinics, on the battlefield, or for pandemics. Exthera Medical has decades of experience in the development and manufacture of blood-contacting implants, devices, and the biomaterial technologies that make them work. With a growing body of data from independent clinical studies, participation in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US and EU, the company is well positioned to serve healthcare professionals and patients alike. For more information, visit www.extheramedical.com.
About BOATM Biomeidcal
BOA Biomedical is a MirakiTM Innovation focused on infectious disease. Our mission is to provide governments, warfighters, nurses, doctors and patients with innovative tools to fight the world’s most deadly infectious diseases and their outcomes including sepsis, hospital-acquired infections, antibiotic resistance, pandemic infections, pathogenic outbreaks and the threat of bioterrorism. We have an exclusive global license to the platform technology from the Wyss Institute at Harvard University. BOA has developed a suite of products which provide patient management for infectious disease throughout the patient journey from diagnosis to tracking to treatment. For more information, visit www.boabiomedical.com.