MARTINEZ, Calif. – ExThera Medical is pleased to announce that published data from a preliminary European study demonstrating in vitro adsorption of human circulating tumor cells (CTC) has been corroborated at a major US cancer center. CTCs are responsible for the often-fatal spread or metastasis of localized cancers to other parts of the body.
This earlier German study confirmed that cultured neuroblastoma, prostate, and leukemia CTCs bind to the adsorption media in the company’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), which was developed to remove bacteria and viruses, often in immunocompromised patients. The recent USA study reconfirmed prostate CTC binding, and demonstrated binding of metastatic pancreatic, breast, lung and colon cancer CTCs isolated from the blood of patients who underwent conventional cancer therapies.
“These results await a peer-reviewed publication, but they are encouraging and warrant clinical study ASAP,” said Robert Ward, CEO for ExThera Medical. “If clinical research confirms safety and efficacy, we see the possibility of a dialysis-like therapy that might prevent metastasis or extend the life of patients with existing metastatic cancer. Based on our experience treating COVID-19 and sepsis, we expect that even repeated and/or regular treatments with Seraph 100, would be well tolerated by patients, compared to chemo-radiation therapies.” CTC levels in blood drawn from cancer patients can be monitored by existing diagnostic tests and help predict Overall Survival (OS) of cancer patients. However, no therapy is currently available to remove CTCs directly from the blood in quantities that could extend OS.
The European results were first presented in Sept 2021 at the Deutsche Gesellschaft für Nephrologie (DGfN) conference in Berlin as part of a scientific collaboration with University Hospital Frankfurt to evaluate clinical feasibility of metastatic cancer cell removal from the bloodstream: “Absorption of Circulating Tumor Cells by Hemoperfusion.” (https://extheramedical.com/publications/). Other results also demonstrated reduction in cancer exosomes (CE’s).
“We are extremely excited by the results because these data suggest that Seraph 100 filter could make an impact on the outcomes of patients with metastatic cancer. We do not have effective treatments for many cancers after metastasis, and these data suggest that we can use a filter technology to perform ‘oncopheretic treatment,’ which could be a candidate therapy for the National Foundation for Cancer Research (NFCR) Cancer Moonshot program.” said Lakhmir Chawla, MD and Medical Advisory Chair for Exthera Medical.
Based on these datasets, ExThera Medical plans to open a cancer hemadsorption Investigational Device Exemption (IDE) trial with the FDA by Q2, 2023.
Metastatic cancer research is a critical area of clinical research and represents a significant patient population. It is estimated that more than 600,000 patients in the United States will die from cancer in 20221, of which 90% will be from metastatic causes2. Metastatic cancer lacks effective therapies as it is often resistant to chemotherapy, radiation, and immunotherapy. Published studies show that the concentration of CTC’s and CEs in a patient’s blood is linked to outcomes in metastatic cancer. Higher counts of CTC and CE cells in the blood are linked to higher probability of death. Experimental methods which remove both CTCs and CEs have been shown to improve outcomes in animals. CTCs and CEs are key pathways for cancer progression and metastasis. Effective removal of CTCs and CEs is therefore likely to impact outcomes in patients with metastatic cancer.
Ward continued, “The observed rapid removal of CTCs and CEs from blood appears similar to the reduction rate we’ve seen for bacterial and viral pathogens when treating bloodstream infections with Seraph 100. We are committed to additional testing of this novel treatment to support the vision of a new therapy for late stage/metastatic cancer patients.”
- https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf
- Guan Xiangming, Cancer metastases: Challenges and opportunities, APSB; 5(5)402-18
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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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