On September 25, 2024 ExThera Medical reported the completion of the Phase I OSCAR I STUDY (ONCObind CTC Removal Study NCT) at OU Health Stephenson Cancer Center, the clinical partner of the University of Oklahoma (Press release, ExThera Medical, SEP 25, 2024, View Source [SID1234646870]). The OSCAR 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).
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A total of five patients with PDAC have completed the ONCObind Procedure with no safety concerns or signals that have been observed. Data has subsequently been submitted to the FDA for review and approval, in order to proceed to the second phase of the feasibility trial (OSCAR II), with a proposal for expanding the patient population to include Metastatic Colorectal Cancer (MCRC), in addition to metastatic PDAC.
"We are happy to report that the ONCObind Procedure was well tolerated by all patients," said ExThera Medical Chairman and President Bob Ward, Ph.D., NAE. "We were also pleased by the rapid reduction in patients’ sedimentation rates and their noticeable improvement in appetite."
Sanja Ilic, M.D., M.S., RAC and the chief regulatory officer for ExThera, added, "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."
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 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. 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.