ExThera Medical has successfully completed the Phase I OSCAR I Study at OU Health Stephenson Cancer Center, affiliated with the University of Oklahoma. The OSCAR I Study is a prospective, single-arm feasibility trial designed to assess the initial safety and potential efficacy of the ONCObind Procedure Hemoperfusion Filter in removing circulating tumor cells (CTCs) from the blood of patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
A total of five patients with metastatic pancreatic ductal adenocarcinoma (PDAC) have successfully undergone the ONCObind Procedure, with no safety concerns reported. Following this, ExThera Medical has submitted data to the FDA for review to advance to the second phase of the feasibility trial, OSCAR II. This phase aims to expand the patient population to include those with metastatic colorectal cancer (MCRC) alongside metastatic PDAC.
“We are pleased to report that the ONCObind Procedure was well tolerated by all patients,” said Bob Ward, Ph.D., NAE, Chairman and President of ExThera Medical. “We also observed a rapid reduction in patients’ sedimentation rates and a noticeable improvement in their appetite.”
Sanja Ilic, M.D., M.S., RAC, ExThera’s Chief Regulatory Officer, added, “Our partnership with the team at Stephenson Cancer Center is strong, and we look forward to collaborating on future studies for pancreatic and potentially colorectal cancer.”
The ONCObind Procedure Hemoperfusion Filter is part of the Onco-Seraph platform technology, which is designed to filter circulating tumor cells (CTCs) from the bloodstream. CTCs shed from primary tumors contribute to metastasis, the leading cause of cancer-related deaths. The ONCObind Procedure utilizes ExThera’s Seraph® 100 Microbind® Affinity Blood Filter technology, which has shown promise in reducing CTCs in recent in vitro studies. Both the ONCObind Procedure Hemoperfusion Filter and the Seraph® 100 Microbind® Affinity Blood Filter are investigational medical devices in the U.S. and are not yet FDA-approved for sale or distribution.
For more information on the OSCAR I study, click here.
About ExThera Medical Corporation
ExThera Medical Corporation specializes in developing extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter, which targets a wide range of pathogens in the bloodstream. This device can be used in various settings, including hospitals and clinics, to combat infections stemming from nosocomial and community-acquired sources, as well as battlefield wounds, pandemics, and biological threats. ExThera’s products have shown life-saving potential in critically ill patients suffering from sepsis, COVID-19, and other severe bloodstream infections. With an expanding body of clinical evidence, success in the DARPA Dialysis-Like Therapeutics program, and operational use in the U.S., EU, and Middle East, ExThera is well-positioned to support healthcare professionals and patients. The Seraph® 100 has received CE Mark approval and is commercially available in the EU, while it remains an investigational device in the U.S., where it has received Emergency Use Authorization (EUA) for treating COVID-19.
