SPL Medical announces fast achievement of next major clinical development milestone for its breakthrough platform product Ferrotran®: 100 patients included in Phase III trial
SPL Medical announces achievement of major Phase III clinical development milestone for its breakthrough platform
product Ferrotran®
Nijmegen, The Netherlands, 14.12.2022 – SPL medical has its proprietary iron-based nanoparticle Ferrotran® (Ferumoxtran) product and platform in clinical Phase III. The pivotal trial named PROSTAPROGRESS has now reached a major milestone by inclusion of more than 50 % of the planned patient group into this trial.
Major academic centres 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 metastases 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.
With this achievement, SPL medical can envision application for market approval in Europe by the end of 2023 already.
- “Having achieved over 50 % patient inclusion so shortly after the Covid pandemic is a major milestone in the clinical phase II development and brings Ferrotran® close to market authorization application”, says Dr. Jürgen Feuerstein, CEO for SPL medical.
- “We are very pleased to have achieved this milestone albeit all restrictions during Covid pandemic. The dedication of the clinical sites in participating prestigious academic centres underlines the attractiveness 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 Oxide). Ferrotran® can be applied 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 is currently under investigation for use in various other cancers.
Ferrotran® is safe, 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.
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.
For more information about Ferrotran®, the clinical trials or SPL medical:
Dr. Juergen Feuerstein (CEO) at +49 171 173 5476
SPL Medical announces collaboration with NanoEcho for application of Ferrotran® (Ferumoxtran) for Ultrasound detection of Lymph node metastases.
Nijmegen, The Netherlands, 28.09.2022 – SPL medical and NanoEcho have signed a Letter of Intent and initiated a cooperation on regulatory partnership and supply for SPL medical proprietary iron-based nanoparticle Ferrotran® (Ferumoxtran) product and platform. Initially NanoEcho is aiming for market approval for the detection of lymph node metastases in rectal cancer patients.
In NanoEcho’s method for diagnostics of rectal cancer lymph node metastases, modern ultrasound technology is used together with iron-oxide nanoparticles. For the clinical effectiveness of the system, the choice of the appropriate nanoparticle is essential.
Ferrotran®, the lymphotropic nanoparticle of SPL medical, is in advanced phase III for the detection of lymph node metastases 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.
With this collaboration with NanoEcho the Ferrotran® platform technology will be extended also to modern ultrasound technologies.
- “The extension of the scope of applicability of Ferrotran® to ultrasound technology demonstrates the wide power of our platform technology beyond the broad field of nano-MRI”, says Dr. Jürgen Feuerstein CEO for SPL Medical.
- “We are very pleased to have established this collaboration with SPL medical. This is an important step in our journey. Based on our initial evaluation, the particle provided by SPL medical looks very promising for our application. Their expertise in the development and commercialization of nanoparticles is impressive and will be very beneficial for us at NanoEcho”, says Dr. Linda Persson CEO for NanoEcho.
About Ferrotran®:
Ferrotran® belongs to the group of USPIO’s (Ultrasmall Superparamagnetic Particles of Iron Oxide). Ferrotran® can be applied in MRI as a safe bloodpool agent for angiography and for functional diagnostics in detection of even the smallest lymph node metastases in prostate cancer patients and is currently under investigation for use in various other cancers.
Ferrotran® is safe, 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.
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.
For more information about Ferrotran®, the clinical trials or SPL Medical:
Dr. Juergen Feuerstein (CEO) at +49 171 173 5476
SPL Medical is pointing out a powerful publication in Investigative Radiology elaborating a new reading algorithm for nano-MRI with Ferrotran® (Ferumoxtran) for the detection of even very small lymph nodes in head & neck cancer patients.
The paper (DOI: 10.1097/RLI.0000000000000902) can be downloaded at High_Accuracy_Nodal_Staging_of_Head_and_Neck.34.pdf
A major conclusion of the authors is:
“Radiological analysis revealed that metastatic lymph nodes showed equal or higher MRI signal intensity when compared with lipid tissue on T2*-weighted MGRE sequence (15/16 lymph nodes; 94%), whereas healthy lymph nodes showed lower (17/19 lymph nodes; 89%) or complete attenuation of signal intensity (273/279; 98%) when compared with lipid tissue on T2*-weighted MGRE. Histopathology of all resected specimens identified 392 lymph nodes.”
Press Release:
SPL Medical is pointing out a powerful publication in European Urology Focus highlighting the useability of Ferrotran® (Ferumoxtran) for MR-Angiography (MRA) even in renally impaired patients thus providing access to another market of approx. 1.5 bln USD with high growth rates.
Nijmegen, The Netherlands, 23.03.2022 – SPL Medical announced today the publication and online availability of the full paper in European Urology Focus about the use of Ferrotran® for MR-Angiography (MRA). A retrospective analysis of 381 patients’ data revealed strong conclusions:
Conclusions
Ferumoxtran MRA showed excellent image quality and visibility for pelvic vessels. In addition, the homogeneity of the intraluminal contrast was superior. Patients with preterminal or terminal renal function can benefit from Ferumoxtran MRA (…)
Patient summary Magnetic resonance imaging of blood vessels using a contrast agent called Ferumoxtran is a promising technique for patients with impaired kidney function, as it provides high-quality visualization of blood vessels (…)
On top of the well-known use of Nano-MRT with Ferrotran® to detect even very small lymph node metastases in prostate cancer patients, this new indication can now enable access to the fast growing 1.5 bln USD market segment of angiography. Today, angiography with contrast enhancement is only accessible with severe limitations in patients who need it most – patients with renal impairment. Contrast agents based on iodinated compounds (for X-ray or computer tomography) are contraindicated and Gadolinium based agents (for use in Magnetic Resonance Imaging) can be used only with severe restrictions due to the significant risk of deposits with potential harm in this patient group.
Ferrotran® is available already now to patients within the running phase III trial PROSTAPROGRESS, but as well in a named-patient-use program in Nijmegen, Netherlands and in a compassionate use programme in Zurich, Switzerland.
“Enabling for an efficient diagnosis for all patients including those who need it most is an essential step forward in the development of Ferrotran® and SPL can thus gain access to this fast-growing market of currently approx. 1.5 bln USD”, stated Dr. Jürgen Feuerstein, Chief Executive Officer of SPL medical.
About Ferrotran®:
Ferrotran® belongs to the group of USPIO’s (Ultrasmall Superparamagnetic Particles of Iron Oxide). Ferrotran® can be applied in MRI as a safe bloodpool agent for angiography and for functional diagnostics in detection of even the smallest lymph node metastases.
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.
For more information about Ferrotran®, the clinical trials or SPL Medical:
Dr. Juergen Feuerstein (CEO) at +49 171 173 5476 or
For further information please visit: www.ferrotran.com
SPL Medical presenteert een nieuwe publicatie in European Urology Focus waarin de bruikbaarheid van Ferrotran® (Ferumoxtran) voor MR-angiografie wordt benadrukt op basis van 381 patiëntengegevens. Ferrotran® (Ferumoxtran)
Conclusions
Ferumoxtran-10 MRA showed excellent image quality and visibility for pelvic vessels. In addition, the homogeneity of the intraluminal contrast was superior. Patients with preterminal or terminal renal function can benefit from ferumoxtran-10 MRA if visualization of their pelvic vessels is required.
Patient summary
Magnetic resonance imaging of blood vessels using a contrast agent called ferumoxtran-10 is a promising technique for patients with impaired kidney function, as it provides high-quality visualization of blood vessels in the pelvis.
…
SPL Medical hoogtepunten publicaties in Healthcare Europe over de behandeling van prostaatkanker en nano-MRT met Ferrotran® (Ferumoxtran)
De artikelen van Prof. Heverhagen en Prof. Hadaschik (alleen in het Duits).
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SPL Medical announces long-term distribution agreement partnership for its novel contrast agent Ferrotran® (Ferumoxtran) for the Korean market
Game-changing prostate cancer imaging agent market access in Korea.
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Dr. Jürgen Feuerstein, CEO van SPL medical nam deel aan de 1e Radboudumc Investeringsdag in Nijmegen, Nederland.
Het was een perfect evenement om elkaar te leren kennen en ideeën uit te wisselen tussen bedrijven, investeerders en wetenschappers in het Experience Center van Radboudumc in Nijmegen. Veel kansen en uitdagingen werden besproken en contacten tussen investeerders en bedrijven werden gelegd of versterkt.
nano-MRT met Ferrotran® (Ferumoxtran) in het laatste nummer van het BPS-magazine van het Bundesverband Prostatakrebs Selbsthilfe e.V.
In het laatste nummer 02/2021 van het BPS Magazin op pagina 13-15 staat een gedetailleerd rapport over nano-MRT met Ferrotran® (Ferumoxtran), waarin deze belangrijke innovatie aan patiënten wordt uitgelegd voor een optimale behandeling op basis van verbeterde lymfeklierdiagnostiek.
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PRESS RELEASE
SPL Medical announces the first time mentioning of its novel contrast agent Ferrotran® (Ferumoxtran) in the German S3-guidelines for Prostate Cancer
Novel imaging agent mentioned in German S3-Guidelines Prostate Cancer
Nijmegen, Netherlands, 27.05.2021 – SPL Medical announced today that the new issue of the German S3-guidelines for prostate cancer, released this month by the Guideline Program Oncology of the German Cancer Society, Deutsche Krebshilfe and AWMF, for the first time is mentioning Ferrotran® (Ferumoxtran) on page 25 of the Guideline Report document.
…
Head-to-head comparison of 68Ga-prostate-specific membrane antigen PET/CT and ferumoxtran-10 enhanced MRI for the diagnosis of lymph node metastases in prostate cancer patients
The goal of this first study comparing Nano-MRI (MRI with a ferumoxtran-10 contrast agent) and 68Ga PSMA- PET/CT was to investigate a potential complementary role for these novel imaging modalities in identifying suspect lymph nodes in prostate cancer patients. Nano-MRI in a comparison with 68Ga-PSMA- PET/CT identified significantly more suspected lymph nodes; at the same, nano-MRI appeared to be superior in detecting smaller suspicious LNs. Both methods seem to be complementary in their potential clinical use.
Nano-MRI outduels PSMA-PET/CT for prostate cancer
Clinicians looking to accurately classify suspicious lymph nodes in prostate cancer patients could have another effective noninvasive option with a unique contrast-enhanced MR imaging technique, according to a study published online January 30 in the Journal of Nuclear Medicine.
Auf der Spur kleinster Metastasen
Jedes Jahr erkranken in der Schweiz rund 6400 Männer neu an Prostatakrebs, 1300 sterben daran. Damit ist das der häufigste Tumor bei Männern.
Die Prognose hängt stark von seiner Ausbreitung ab. Krebszellen können über die Lymphbahnen in die benachbarten Lymphknoten der Beckenregion oder über die Blutgefässe in andere Organe gelangen – in Knochen, Lungen, Leber.
Lees het volledige artikel (alleen in het duits): Prostatakrebs BZ_neu.
Niet-invasieve detectie van klinisch occulte lymfekliermetastasen bij prostaatkanker
MRI met hoge resolutie met magnetische nanodeeltjes maakt de detectie van kleine en anders niet-detecteerbare lymfekliermetastasen bij patiënten met prostaatkanker mogelijk.
MRI met een lymfeklier-specifiek contrastmiddel als alternatief voor CT-scan en lymfeklierdissectie bij patiënten met prostaatkanker: een prospectieve multicohortstudie
MRL had significant hogere gevoeligheid en NPV dan MDCT voor patiënten met prostaatkanker met een intermediair of hoog risico op lymfekliermetastasen. Bij dergelijke patiënten is de post-testkans om lymfekliermetastasen te hebben na een negatieve MRL laag genoeg om een PLND weg te laten.
BE IMAGING GmbH investeert in SPL Medical B.V.
De onderneming b.e. imaging GmbH, onderdeel van de Bender Gruppe GmbH, en SPL Medical B.V. hebben een exclusieve overeenkomst getekend voor de marketing van Ferrotran.
Prostate Cancer: Detection of Lymph Node Metastases Outside the Routine Surgical Area with Ferumoxtran-10–enhanced MR Imaging
Prostaatkanker: detectie van lymfekliermetastasen buiten het routine-operatiegebied met Ferumoxtran-10 verbeterde MR-imaging.
PERSBERICHT – contrastmiddel maakt vroeg stadium van lymfeklierkankermetastasen zichtbaar
Apeldoorn, Nederland, 3 mei 2017
Radboudumc gebruikte Ferrotran (Ferumoxtran-10) van het Nijmeegse bedrijf SPL Medical met succes bij honderden patiënten; een nieuwe investeringsronde voor de Europese registratie van Ferrotran.
De in Nijmegen gevestigde SPL Medical, een spin-off van Radboudumc, heeft een uniek MRI-contrastmiddel (Ferrotran) dat kankermetastasen in een vroeg stadium in de lymfeklieren kan detecteren. Het contrastmiddel is bij Radboudumc bij honderden kankerpatiënten gebruikt. Door nieuwe investeringen door het Duitse farmaceutische bedrijf b.e. imaging GmbH en PPM Oost, SPL Medical wil de Europese registratie van Ferrotran financieren om de diagnose van prostaatkanker metastasen in de lymfeklieren mogelijk te maken. Latere aanvullende aanwijzingen zullen volgen.
PRESS RELEASE – SPL Medical receives approval for Clinical Trial with contrast agent Ferrotran® in 10 top radiology centers.
Nijmegen, Netherlands, March 15, 2019
SPL Medical BV has received approval of the German regulatory body for pharmaceutical products BfArM, to the start of a multicenter clinical trial of Ferrotran®. This is a novel contrast agent (based on Ferumoxtran-10) for use in MRI (magnetic resonance imaging), developed for the (early) detection of lymph node metastases of prostate cancer. Ferrotran® is the only contrast agent that can detect lymph node metastases as small as 2 mm. Standard MRI or CT are normally not able to detect nodes smaller than 7-8 mm.
EMUC 2020: Nanoparticles in Prostate Cancer: A Perspective for the Future
(UroToday.com) The European Multidisciplinary Congress on Urological Cancers (EMUC) 2020 virtual meeting featured a discussion of nanoparticles in the Fragments of Imaging session by Dr. Jelle Barentsz. Dr. Barentsz notes that according to the European Association of Urology (EAU) guidelines, pelvic lymph node dissection is the gold-standard for lymph node staging, however, 13% of positive lymph nodes are not detected by pelvic lymph node dissection. According to Dr. Barentsz, the reason for the missed lymph node detection is secondary to surgeons looking for small (<4 mm) lymph nodes deep in the pelvis or higher up in the peri-aortic regions. Because of these nuances and in an effort to improve detection, there is a role for lymph node imaging in these high-risk prostate cancer patients. According to Dr. Barentsz, 68Ga-PSMA PET/CT has a poor role in lymph node staging, detecting microscopic disease in only ~9% of high risk patients, secondary to an inability to detect lymph node metastasis when the positive lymph node is <4.0 mm. A new technique introduced by Dr. Barentsz is nano-MRI, using ferrotran (ferumoxtran-10), which is a contrast agent that consists of nano-sized iron oxide particles.
Ferumoxtran opent een nieuwe diagnostische deur
Lees hier (alleen in het Duits):
Vision Update No. 15; 05.2021