Sanochemia/SPL: Investigational Iron-Based MRI Contrast Agent Meets Primary Endpoints in Pivotal Phase III Study

NEUFELD, Austria, Feb. 25, 2025 /PRNewswire/ -- Sanochemia Pharmazeutika today announced positive headline results of the pivotal phase III study PROSTAPROGRESS on Ferumoxtran (EudraCT 2018-004310-18), performed by SPL Medical B.V. (Nijmegen, The Netherlands). The multicentric prospective study confirmed the sensitivity and specificity primary endpoints.

Ferumoxtran is an MRI Contrast Agent that may be used to detect lymph node metastases as small as 2 mm in prostate cancer patients. Sanochemia has secured exclusive global commercialization rights together with its shareholder b.e.imaging (Germany, Switzerland, France).

The multicentric prospective PROSTAPROGRESS Study investigated the use of Ferumoxtran as MRI contrast agent for lymphatic metastases in prostate cancer. On top, angiography data were assessed. The trial included prostate cancer patients with a medium to high risk of lymph node metastases and without prior treatment. The study confirmed the sensitivity and specificity primary endpoints. In parallel, angiography data from the trial showed mostly excellent or good angiography readability as judged by the central readers of the trial. The safety data from the ongoing safety monitoring revealed consistency with other major Gd-based MRI contrast agents.

"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," said Sanochemia Managing Director Thomas Erkinger. "The aim now is to bring Ferumoxtran to the international markets as quickly as possible once regulatory approval has been granted."

"Meeting the primary endpoints in the PROSTAPROGRESS trial 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", said Dr. Patrik Zamecnik, Medical Advisor to both SPL and Sanochemia.

About Ferumoxtran

Ferumoxtran consists of Ultrasmall Superparamagnetic Particles of Iron Oxide (USPIO). The dextran-coated iron oxide nanoparticles accumulate in macrophages, leading to a significant decrease in MRI signal. The dosage applied, 2.6 mg Fe/kg body weight, is significantly lower than the usual dosage for the widely used i. v. iron substitution products. Ferumoxtran may be applied in MRI as a blood pool agent for angiography and for functional diagnostics in conjunction with the detection of even very small lymph node metastases. Ferumoxtran is already available in a named-patient-use program in Nijmegen, Netherlands.

 About Sanochemia Pharmazeutika

Sanochemia is a leading European supplier of pharmaceuticals for radiological applications. In addition to classic contrast agents, the company focuses on pioneering organ-specific and gadolinium-free agents. The company's imaging agents are used by doctors and hospitals in over 50 countries worldwide for diagnostic imaging in MR and CT procedures.

CONTACT:  Kerstin Schanda, [email protected], +43 50 7 266 0

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SOURCE Sanochemia Pharmazeutika