MARTINEZ, Calif.--(BUSINESS WIRE)--The first patient has been enrolled in ExThera Medical’s OSCAR I STUDY (ONCObind CTC Removal Study) clinical study at OU Health Stephenson Cancer Center, the clinical partner of the University of Oklahoma. The study is a Prospective Single-Arm Feasibility trial to evaluate the initial safety and signals of efficacy by determining the ability of the ONCObind procedure hemoperfusion filter to remove Circulating Tumor Cells (CTCs) from the blood of patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
"The enrollment of the first patient in the OSCAR I STUDY is a significant milestone in our mission to provide innovative treatment options for cancer patients," said Erin Borger, CEO of ExThera Medical. "This trial represents the opportunity to offer potential new hope for patients with metastatic PDAC, who currently face limited options and poor prognosis.”
The ONCObind procedure hemoperfusion filter is the product brand name for the Onco-Seraph platform that is an extracorporeal blood filtration procedure designed to target and filter out CTCs from the bloodstream of patients. CTCs are shed from primary tumors and contribute to metastasis, which is responsible for most cancer-related deaths. The ONCObind procedure uses a blood filter based on ExThera’s Seraph® 100 Microbind® Affinity Blood Filter technology, which has shown significant success in reducing CTCs in a recent in vitro study.
The OSCAR I Trial is expected to enroll 5 patients with PDAC, followed by the OSCAR II feasibility trial. Pharmacokinetics/Pharmacodynamics will be the study focus of OSCAR I in the first 5 patients before expanding to additional participants. Patients will receive standard of care follow up for up to 5 years. This trial marks a significant first step toward FDA approval and commercialization of this cutting-edge treatment option. Further details on the OSCAR I study can be found here.
About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph® 100 can be used in hospitals, clinics, on battlefields and in other austere environments to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US, the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph® 100 attained CE Mark and is commercially available in the EU under a broad Indication For Use. The Seraph® 100 has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the USA.
For more information, visit the company’s website at www.extheramedical.com.
About Seraph® 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph® 100 filter, it passes through a bed of small beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Many harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph® adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.
ExThera Medical is currently developing the ONCObind™ Procedure Hemoperfusion Filter (ONCObind™) to support cancer treatment. ONCObind™ is part of the same platform technology as Seraph® 100.
For more news stories on Seraph® 100 and ONCObind™, click here.
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