Dialysis-like Cell Removal Therapy to be Studied for Treating Metastatic Cancer
MARTINEZ, Calif., September 20, 2022--(BUSINESS WIRE)--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."
Guan Xiangming, Cancer metastases: Challenges and opportunities, APSB; 5(5)402-18
About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis and other severe 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 US, the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100® attained CE mark and is commercially available in the EU. The Seraph 100® has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the USA.
For more information visit the company’s website at www.extheramedical.com.
About Seraph 100
As a patient's blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph 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 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 bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.
For more news stories on the Seraph 100 click here.
All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. 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. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220920006166/en/