CONTACT: Stephanie Connolly
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First Patients Underwent ONCObind Procedure at Stephenson Cancer Center in Groundbreaking Pancreatic Cancer Trial
MARTINEZ, CA- ExThera Medical has announced 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. 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).
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.
Further details on the OSCAR I study can be found here.
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About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes 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 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 U.S., the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike.
The Seraph 100 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. 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 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information, visit the company’s website at https://extheramedical.com/.
About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph® 100 Microbind® Affinity Filter (Seraph 100), 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 100 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.
ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.
For more news stories on Seraph 100 and ONCObind, click here.
Disclaimer
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.
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