Neufeld, Austria – Sanochemia Pharmazeutika today announced further positive 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 to also meet secondary endpoints. Post-hoc analysis showed elevated sensitivity and specificity data for metastatic lymph node lesions at levels surpassing the levels of current technologies.
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. The trial included prostate cancer patients with a medium to high risk of lymph node metastases and without prior treatment.
The study has not only confirmed the primary endpoints but also has been successful in the achievement of further secondary endpoints. Additionally, post-hoc analysis revealed elevated sensitivity and specificity data for metastatic lymph node lesions at levels beyond current technologies (Pienta et al. J Urol. 2021 July;206(1): 52–61).
“The secondary results surpassing the performance levels of current imaging standards means a major 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.”
“The post-hoc analysis confirmed the ability of Ferumoxtran-enhanced MRI to detect even small intranodal lymph node metastases in normal sized lymph nodes in prostate cancer patients making the lymph node staging more precise”, said Dr. Patrik Zamecnik, Medical Advisor to both SPL and Sanochemia.
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.