Press release
SPL Medical announces achievement of next major clinical development milestone for its breakthrough platform product Ferrotran®: Now >75% patients included in Phase III trial
Nijmegen, The Netherlands, 02.08.2023 - SPL medical has its proprietary iron-based nano-particle Ferrotran® (Ferumoxtran) product and platform in clinical Phase III. The pivotal trial named PROSTAPROGRESS has now reached the next major milestone by inclusion of over 75% of the patients into this trial.Major academic centers in The Netherlands, Belgium, Germany and Switzerland are contributing constantly.
With the PROSTAPROGRESS trial, SPL will verify the superior efficacy and state-of-the-art safety of Ferrotran®, the lymphotropic nanoparticle of SPL medical, for the detection of lymph node me-tastases for prostate cancer patients with Magnetic Resonance Imaging (MRI).
The Ferrotran® particle has been developed as a platform technology for various applications for the broad base of installed MRI scanners worldwide.
- "Having now reached an inclusion level of more than 75% is a major step in the clinical phase III development and brings Ferrotran® even closer to market authorization appli-cation", says Dr. Jürgen Feuerstein, CEO for SPL medical.
- "We are very pleased to have achieved this next milestone so efficiently. The dedication of the clinical sites in participating prestigious academic centers underlines the attrac-tiveness and clinical need for an advanced lymph node imaging for the sake of improved patient diagnosis, treatment, and hence clinical outcome".
-
About Ferrotran®:
Ferrotran® belongs to the group of USPIO's (Ultrasmall Superparamagnetic Particles of Iron Ox-ide). Ferrotran® is currently under investigation for use in various other cancers for application in MRI as a safe blood pool agent for angiography and for functional diagnostics in detection of even the smallest lymph node metastases in prostate cancer patients and.
Ferrotran® has a distinct safety profile, as it is based on iron and therefore metabolized naturally in the body.
Ferrotran® is in advanced phase III in various prestigious European University Hospitals.
Ferrotran® has been applied successfully in over 700 patients in the Netherlands and Switzerland in special approval permissions.
Dr. Juergen Feuerstein
Toernooiveld 100
6525EC Nijmegen
The Netherlands
www.ferrotran.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 b.e.imaging GmbH, a German company specialized in the development and commercialization of contrast agents.
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