Press release
Ferumoxtran, the iron-based investigational MRI contrast agent of SPL Medical B.V., meets also secondary endpoints in pivotal Phase III study.
Dr. Juergen Feuerstein, CEO SPLmedical
Patients with known prostate cancer with intermediate to high risk of lymph node metastases without prior treatment were enrolled in the trial.
The multicentric prospective PROSTAPROGRESS study has not only confirmed the primary endpoints but also has been successful in the achievement of further secondary endpoints.
Additionally, a 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).
"Meeting the endpoints in the PROSTAPROGRESS trial even reflecting very small lesions can be regarded as major technology breakthrough. Bringing Ferumoxtran to the market after regulatory approval has been achieved will be our next big milestone, as the technology promises to be beneficial for prostate cancer patients", said Dr. Jürgen Feuerstein, CEO SPL Medical B.V.
"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 SPL Medical B.V.
About the phase III study PROSTAPROGRESS
PROSTAPROGRESS (EudraCT 2018-004310-18) included prostate cancer patients with a medium to high risk of lymph node metastases and without prior treatment in renowned university centers in Germany, Netherlands, Belgium and Switzerland. The study was concluded in January 2025.
About Ferumoxtran
Ferumoxtran belongs to the group of USPIO's (Ultrasmall Superparamagnetic Particles of Iron Oxide). It does not contain Gadolinium but is based on iron, a physiologically required metal. 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 has the potential to be applied in MRI as a safe bloodpool agent for angiography and for functional diagnostics in detection of even very small lymph node metastases. Ferumoxtran is available already now in a named-patient-use program in Nijmegen, Netherlands.
About MRI
Contrast enhanced MRI plays a key role in medical diagnostics with estimated annual procedures above 60 million. MRI is a radiation free method providing essential information for medical practice to support physicians in patient treatment by providing information in relation to detect, characterize and monitor diseases.
For more information about Ferrotran®, the clinical trial or SPL Medical:
Dr. Juergen Feuerstein (CEO) at +49 171 173 5476
For further information please visit: www.splmed.com
About SPL Medical:
SPL medical is a spin-off of the Radboud university medical center and is funded additionally by Oost NL, a Dutch regional venture capital company, and the major shareholder b.e.imaging GmbH, a German company specialized in the development and commercialization of contrast agents.
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