Pancreatic cancer is one of the most challenging cancers to treat. It is often diagnosed late, treatment options are limited, and patients and physicians alike must make important decisions based on incomplete or delayed information.
ElmediX has developed an innovative medical device, the TempoCure®, to deliver whole body hyperthermia to metastatic adenocarcinoma patients.
In 2025 we have successfully concluded ‘MATTERS’ – our safety clinical trials, and we are now actively working on the design of our next safety study: MATTERS-2.In this process it is essential to identify all potential efficacy signs to advance the scientific understanding of how this disease responds to therapy.
ElmediX has recently published a scientific article titled “CA19-9 as a Dynamic Biomarker for Continuous Monitoring of Therapeutic Efficacy in Pancreatic Adenocarcinoma” in the international oncology journal Cancers
Our article focuses on a simple blood test, CA19-9, and how it can help clinicians closely monitor the evolution of pancreatic cancer by promptly detecting even subtle signals of growth or shrinkage.
These insights connect directly to what we observed in our first-in-human trial and how we are designing our next study.
CA19-9 is a blood biomarker that has been used for many years in the care of patients with pancreatic cancer. It is not effective for early detection or screening, and it does not work in all patients. However, once pancreatic cancer has been diagnosed, CA19-9 can provide valuable information.
Our scientific review highlights an important feature of CA19-9: it can change quickly in response to what is happening in the body. Because of how it is produced and cleared, CA19-9 levels can rise or fall over relatively short periods of time, often reflecting changes in tumour activity.
For patients and clinicians, this means CA19-9 can be useful to:
Despite these advantages, CA19-9 is sometimes underused or interpreted too narrowly. We believe it has an important role to play when used thoughtfully and in the right clinical context.
CA19-9 Observations in the MATTERS Clinical Trial
These ideas became especially relevant during MATTERS, ElmediX’s first-in-human clinical trial. MATTERS primarily evaluated the safety and tolerability of repeated whole-body hyperthermia sessions, delivered with TempoCure®, alone or alongside standard chemotherapy.
While MATTERS was not designed to measure treatment effectiveness, CA19-9 levels were monitored as part of routine clinical follow-up.
In several patients with pancreatic cancer, we observed:
Given that the study included a small and diverse group of patients, these findings are exploratory and descriptive. However, the stabilization and decreases in CA19-9 observed during the treatment period represent early positive signals consistent with biological activity, align well with what is known about CA19-9 as a dynamic marker and reinforce its potential value for monitoring disease behaviour over time.
The combination of scientific evidence from our CA19-9 review and the observations from MATTERS has directly influenced the design of MATTERS 2, our upcoming clinical trial in metastatic pancreatic cancer.
MATTERS 2 is designed to evaluate treatment efficacy, and it will use a combined monitoring approach, including:
Importantly, in this study, CA19-9 evolution will be assessed as an exploratory endpoint, meaning it will be studied to better understand how changes in the biomarker relate to imaging results and clinical outcomes. This approach reflects a broader goal: to capture both what tumours look like and how they behave biologically over time.
Our CA19-9 review reinforces an important message: despite its limitations, CA19-9 remains a powerful and underutilized biomarker for continuous disease monitoring in pancreatic cancer. When interpreted appropriately, its dynamic behaviour can provide timely insights that support clinical decision-making.
At ElmediX, we are integrating these insights into our clinical development programs as we continue to explore how whole-body hyperthermia may fit into the treatment landscape for pancreatic cancer. Through MATTERS 2, we aim to deepen our understanding of treatment response while maintaining a strong commitment to safety, transparency, and scientific rigor.
Read our article on: Cancers
ElmediX strives to extend the lives of cancer patients worldwide and improve their quality of life. Initially, our focus is on pancreatic cancer, but other types of cancer are also being studied.