Nijmegen, The Netherlands, 2 August 2023
SPL Medical announces achievement of next major clinical development milestone for its breakthrough platform product Ferrotran®: Now >75% patients included in Phase III trial
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 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 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.
- “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 application”, 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 attractiveness and clinical need for an advanced lymph node imaging for the sake of improved patient diagnosis, treatment, and hence clinical outcome”.
Ferrotran® belongs to the group of USPIO’s (Ultrasmall Superparamagnetic Particles of Iron Oxide). 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.
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
Apeldoorn, The Netherlands, 3 May 2017
Contrast Agent Makes Early Stage of Lymph Node Cancer Metastases Visible
Radboudumc has used Ferrotran (Ferumoxtran-10) from the Nijmegen company SPL Medical successfully in hundreds of patients; a new investment round for European registration of Ferrotran.
The Nijmegen-based SPL Medical, a spin-off from Radboudumc, has a unique MRI contrast agent (Ferrotran) that can detect early-stage cancer metastases in the lymph nodes. The contrast agent has been used at Radboudumc in hundreds of cancer patients. Through new investments by the German pharmaceutical company b.e. imaging GmbH and PPM Oost, SPL Medical wants to finance European registration of Ferrotran to enable the diagnosis of prostate cancer metastases in the lymph nodes. Later additional indications will follow.
The market launch of Ferrotran by SPL Medical is to take place after the registration phase, which is expected to take three to four years. Ari Aminetzah, the CEO of the Nijmegen-based SPL Medical, “With these investments we can bring Ferrotran to the market. The commercial availability of Ferrotran for cancer patients will allow a much more accurate diagnosis of lymph node metastases. This will save lives and prevent unnecessary suffering of patients. This is why there are many parties from around the world who are eagerly wanting to use Ferrotran.”
According to Pieter Rhemrev, Adjunct-director of PPM Oost, SPL Medical can also have an enormous impact on society. “Prostate cancer is the most commonly diagnosed cancer in men. In the Netherlands alone, there are roughly 12,000 new cases per year. Cancer metastases are often discovered at a late stage, in which the survival rates are lower. In addition, the quality of life concerning this group of patients is very poor due to the side effects of therapy and emotional stress. Early detection of lymph node metastases is essential for successful treatment. SPL Medical can play a crucial role here.”
Dirkjan Masman, Director Valorization at Radboudumc, “Innovative research is especially valuable when it is converted into products where patients have real value. Radboudumc invests as actively as possible in these types of projects and it is good if they are leading to investments from the market and concrete products. European registration of Ferrotran would be a wonderful example of this.”
“We at b.e.imaging are convinced that Ferrotran (Ferumoxtran-10) will contribute significantly to the improvement of oncological MRI diagnostics. On top, due to its iron basis, Ferumoxtran-10 cannot be involved in the current hot topic of Gd depositions caused by MRI contrast agents based on Gadolinium. Together with Radboud University Medical Center and PPM Oost, we are investing in the future of MR imaging agents’, says Dr. Jürgen Feuerstein, Managing Director of b.e. imaging.
Extremely high accuracy
Radboudumc, where this contrast agent was further developed, is the only hospital in the Netherlands that has received permission to use Ferrotran. Since 2014 it has been used in more than 700 patients with prostate cancer. With these patients there have been no significant side effects. This form of diagnosis is very accurate, reliable and safe, says Aminetzah. European registration is therefore the next step in making Ferrotran available for more patients.
Ferrotran is applied directly in the bloodstream. 24 – 36 hours later, an MRI scan can be conducted where the lymph node metastases will be visualized. Aminetzah, “In comparison with existing methods, Ferrotran has extremely high accuracy. We can detect metastases of barely 2 mm. With the current techniques available, the patient must wait until the metastases will grow up to 8 – 10 mm before they’re can be detected and treated. With Ferrotran these patients are able to be treated much sooner and with far greater efficacy”.
Ferrotran can work in principle in all cases of solid tumors that spread to the lymph nodes, such as breast cancer. SPL Medical is focusing primarily on registering Ferrotran for prostate cancer patients in Europe. The German company b.e. imaging GmbH, as shareholder of SPL Medical and part of the bender gruppe (Baden-Baden), will distribute Ferrotran in Germany, Switzerland and Austria. Other cancer indications will follow afterwards.
Topfonds Gelderland is a revolving investment fund from the province of Gelderland and is managed by a fund manager from PPM Oost. Through Topfonds Gelderland, PPM Oost is able to invest financing provided by the province in innovative companies and projects in the areas of economic development, sustainable energy initiatives and cultural entrepreneurship in the province of Gelderland. This is accomplished, together with co-investors, in the form of direct investments in commercial enterprises and through investing in market funds.
To date, the province of Gelderland has invested some € 188.75 million in Topfonds Gelderland, of which € 36.5 million has been earmarked for fund investments and the balance (€ 152.25 million) for direct investments in companies throughout Gelderland via five separate sub-funds: Innovation and Energy Fund Gelderland (IEG), SME Credit Facility Gelderland, Restructuring Fund Industrial Parks Gelderland (Dutch acronym: FHBG), Gelderland Leisure Economy Fund (FGV) and the Gelderland Culture Loans Fund (FGC).
PPM Oost is the participative investment agency (venture capital) of the East Netherlands Development Agency (Oost NV), and performs as the regional venture capital investor for East Netherlands. The agency offers not only financing, but also its network, knowledge and know-how to entrepreneurs in the High Tech, Life Tech, Cleantech & Energy sectors, as well as invests in market funds. In addition to investing, it works together with Oost NV to help business owners with innovation, internationalization and business infrastructures.
PPM Oost’s mission is to actively participate and coach: being a part of the society of the future. With funding from the Dutch government as well as the provinces of Gelderland and Overijssel, as well as Region Twente, PPM Oost has invested over its lifetime in some 220 companies and manages fund assets of around €300 million. This has allowed PPM Oost to be an active partner in achieving real results for the regional economy and environment as well as creating jobs.
Radboud University Medical Center
The Radboud University Medical Center (Radboudumc) has its sights set on being a leader in the development of sustainable, innovative, and affordable healthcare. Through this goal, they intend to make a contribution to the health of people and society in the Netherlands and beyond. Its mission is simple, “To have a significant impact on healthcare.”