OU Health Stephenson Cancer Center enrolls first patient for ExThera Medical’s OSCAR I trial

MARTINEZ, Calif. –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.

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.

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About ExThera Medical Corporation

ExThera Medical Corporation develops extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) 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. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from the EU, the company is well positioned to serve healthcare professionals and patients alike.

The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 is not available in the US.

For more information, visit the company’s website at https://extheramedical.com/.

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