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 2022, of which 90% will be from metastatic causes. 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.”
Source – BusinessWire