First Phase of ExThera Medical’s OSCAR I Study Completed

ExThera Medical has completed Phase I of its OSCAR I STUDY (ONCObind CTC Removal Study NCT), which is assessing the efficacy of the company’s ONCObind Procedure Hemoperfusion Filter.

Conducted at OU Health Stephenson Cancer Center—clinical partner of the University of Oklahoma—the prospective single-arm feasibility trial is specifically evaluating the filter’s safety by determining its ability to remove circulating tumor cells (CTCs) from the blood of patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
 
Five PDAC patients completed the ONCObind Procedure with no safety concerns or observable signals. Data has been submitted to the U.S. Food and Drug Administration (FDA) for review and approval, so the company can proceed to the trial’s second phase (OSCAR II). ExThera Medical intends to expand the patient population to include metastatic colorectal cancer (MCRC) in addition to metastatic PDAC.
 
“We are happy to report the ONCObind Procedure was well tolerated by all patients,” ExThera Medical Chairman/President Bob Ward, Ph.D., said. “We were also pleased by the rapid reduction in patients’ sedimentation rates and their noticeable improvement in appetite.”

The ONCObind Procedure Hemoperfusion Filter is the product brand name for the Onco-Seraph platform technology, an extracorporeal blood filtration procedure designed to target and filter out CTCs from the bloodstream. 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. Both the ONCObind Procedure Hemoperfusion Filter and the Seraph 100 Microbind Affinity Blood Filter are investigational medical devices in the United States and are not approved by the U.S. Food and Drug Administration for sale or distribution.

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.
 
“We have a great partnership with the team at Stephenson Cancer Center and look forward to partnering with them on future pancreatic cancer studies, with the potential to expand into colorectal cancer,” ExThera Medical Chief Regulatory Officer Sanja Ilic, M.D., added.  

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. 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 United States, the European Union, 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. The Seraph 100 is an investigational medical device in the United States and has not been approved by the FDA. The agency, however, has issued an Emergency Use Authorization (EUA) that authorizes the Seraph 100’s use to treat COVID-19 in the United States.