ExThera Completes Phase I OSCAR I Trial

ExThera Medical has announced the completion of the Phase I OSCAR I Study (ONCObind CTC Removal Study NCT) at OU Health Stephenson Cancer Center, affiliated with the University of Oklahoma. This Prospective Single-Arm Feasibility Trial aims to evaluate the initial safety and efficacy indicators of the ONCObind Procedure Hemoperfusion Filter in removing Circulating Tumor Cells (CTCs) from the blood of patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

The trial involved five PDAC patients who underwent the ONCObind Procedure without any safety concerns or adverse signals. The resulting data has been submitted to the FDA for review and approval to move forward to the second phase of the feasibility trial (OSCAR II). The next phase proposes an expansion of the patient population to include those with Metastatic Colorectal Cancer (MCRC) as well as metastatic PDAC.

“We are happy 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 were also pleased by the rapid reduction in patients' sedimentation rates and their noticeable improvement in appetite.”

Sanja Ilic, M.D., M.S., RAC, 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 based on ExThera’s Seraph® 100 Microbind® Affinity Blood Filter technology. This extracorporeal blood filtration procedure aims to target and filter out CTCs from the bloodstream. CTCs are known to be shed from primary tumors and are responsible for metastasis, which leads to most cancer-related deaths. The ONCObind Procedure uses a blood filter that has shown significant success 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 United States and are not yet approved by the U.S. Food and Drug Administration for sale or distribution.

ExThera Medical Corporation specializes in developing and commercializing extracorporeal blood filtration devices. These include the Seraph® 100 Microbind® Affinity Blood Filter, which removes a broad range of pathogens from the bloodstream. This technology can be applied in various environments, including hospitals, clinics, battlefields, and during pandemics. ExThera Medical's products have demonstrated life-saving capabilities in critically ill patients suffering from sepsis, COVID-19, and other severe bloodstream infections.

With a growing body of evidence from independent clinical studies and successful clinical use in the US, EU, and Middle East, ExThera Medical is well-positioned to serve healthcare professionals and patients. The Seraph® 100 has attained the CE Mark and is commercially available in the EU under a broad Indication For Use. However, it remains an investigational device in the United States and has not been approved by the FDA for sale or distribution. The FDA has issued an Emergency Use Authorization for the Seraph 100 to treat COVID-19 in the U.S.

The Seraph® 100 filter uses a bed of small beads with receptors that mimic those on human cells, targeting and capturing pathogens and harmful substances from the bloodstream. It adds nothing to the blood and removes harmful substances generated by pathogens and the body's response to infection. The Seraph® 100's proprietary adsorption media uses immobilized heparin for its blood compatibility and ability to bind various harmful entities, including CTCs, bacteria, viruses, fungi, and sepsis mediators.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter to support cancer treatment, using the same platform technology as the Seraph® 100.