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Phase III Trial Success: Ferumoxtran Shows Promise in Detecting Small Prostate Cancer Metastases

• Sanochemia Pharmazeutika's iron-based MRI contrast agent Ferumoxtran successfully met primary endpoints for sensitivity and specificity in the PROSTAPROGRESS Phase III trial.

• The study demonstrated Ferumoxtran's capability to detect lymph node metastases as small as 2mm in prostate cancer patients, offering a potential alternative to gadolinium-based agents.

• The safety profile aligned with major gadolinium-based MRI contrast agents, while using a significantly lower iron dosage of 2.6 mg Fe/kg body weight.

Sanochemia Pharmazeutika announced breakthrough results from their pivotal Phase III PROSTAPROGRESS study of Ferumoxtran, an innovative iron-based MRI contrast agent designed to detect minute lymph node metastases in prostate cancer patients. The multicentric prospective trial successfully achieved its primary endpoints for both sensitivity and specificity.

Advanced Imaging Capabilities

The study evaluated Ferumoxtran's effectiveness in detecting lymph node metastases as small as 2 millimeters in prostate cancer patients with medium to high metastatic risk. Additionally, the trial assessed angiography data, with central readers reporting predominantly excellent to good angiography readability.

Technical Innovation and Safety Profile

Ferumoxtran utilizes Ultrasmall Superparamagnetic Particles of Iron Oxide (USPIO) technology, with dextran-coated iron oxide nanoparticles that accumulate in macrophages, resulting in distinctive MRI signal reduction. The contrast agent requires only 2.6 mg Fe/kg body weight, substantially lower than conventional intravenous iron substitution products. Safety monitoring throughout the trial revealed a profile consistent with established gadolinium-based MRI contrast agents.

Clinical Implementation and Future Prospects

"SPL's study results are an essential step for us in enabling the detection and treatment of lymph node metastases at an earlier stage than before," stated Thomas Erkinger, Managing Director of Sanochemia. The company has secured exclusive global commercialization rights in partnership with b.e.imaging for key European markets.
Dr. Patrik Zamecnik, Medical Advisor to both SPL and Sanochemia, emphasized the significance of meeting the primary endpoints: "This opens great opportunities for further clinical development of Ferumoxtran, a compound which has the potential to significantly improve lymph node metastasis detection using MRI without Gadolinium."
The contrast agent is currently available through a named-patient-use program in Nijmegen, Netherlands, with plans for broader international market expansion following regulatory approval.
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