Sanochemia/SPL Iron-Based MRI Agent Successful in Phase III Study

In NEUFELD, Austria, on February 25, 2025, Sanochemia Pharmazeutika announced the successful results of a significant phase III clinical trial named PROSTAPROGRESS. This study evaluated Ferumoxtran, an innovative contrast agent designed for use in MRI scans, specifically targeting the detection of small lymph node metastases in patients with prostate cancer. The trial was conducted by SPL Medical B.V. based in Nijmegen, The Netherlands, and confirmed the accuracy and reliability of Ferumoxtran in meeting its primary objectives.

Ferumoxtran stands out as a unique MRI contrast agent capable of identifying metastatic lymph nodes as tiny as 2 millimeters. Sanochemia has attained exclusive global commercialization rights for this agent, in collaboration with their shareholder b.e.imaging, which operates in Germany, Switzerland, and France.

The PROSTAPROGRESS trial was a multicentric and forward-looking study aimed at assessing the efficacy of Ferumoxtran as a contrast agent for MRI scans focused on lymphatic metastases in prostate cancer cases. Participants of the trial were prostate cancer patients who had not undergone prior treatments and exhibited a medium to high probability of lymph node metastases. The results of the study affirmed the sensitivity and specificity of Ferumoxtran, achieving its primary goals.

In addition to the primary study outcomes, angiography data was also evaluated. The angiography readings were predominantly rated as excellent or good by the central evaluators, suggesting a high degree of clarity. Moreover, the ongoing safety monitoring of Ferumoxtran indicated that its safety profile aligns well with other major MRI contrast agents based on Gadolinium.

Thomas Erkinger, the Managing Director of Sanochemia, emphasized the significance of these findings, stating that the results are crucial for advancing the early detection and treatment of lymph node metastases, which could potentially be identified at much earlier stages thanks to Ferumoxtran. The focus now shifts to securing regulatory approval to expedite Ferumoxtran's availability in global markets.

Dr. Patrik Zamecnik, serving as a Medical Advisor to both SPL and Sanochemia, highlighted that achieving the primary endpoints in this trial unlocks substantial prospects for further clinical research on Ferumoxtran. This compound holds the promise of enhancing the detection of lymph node metastases via MRI without the need for Gadolinium, thereby representing a significant advancement in medical imaging.

Ferumoxtran is composed of ultrasmall superparamagnetic iron oxide particles, which are encapsulated in a dextran coating. These nanoparticles accumulate in macrophages, resulting in a marked reduction in MRI signals. The administered dosage of 2.6 mg of iron per kilogram of body weight is notably lower than the standard dosages for intravenous iron replacement products. Ferumoxtran can be utilized as a blood pool agent in angiography and for functional diagnostics, aiding in the detection of very small lymph node metastases. It is currently available through a named-patient-use program in Nijmegen, Netherlands.

Sanochemia Pharmazeutika is a prominent European pharmaceutical supplier specializing in radiological applications. While the company provides traditional contrast agents, it places a particular emphasis on pioneering organ-specific and gadolinium-free options for imaging. Sanochemia’s products are utilized by healthcare professionals across more than 50 countries for diagnostic imaging in MRI and CT procedures.