News | Prostate Cancer | December 24, 2019

SPL Medical Announces First Prostate Cancer Metastasis Patient Diagnosed with Ferrotran in Compassionate Use Program

Novel imaging agent allows detection of lymph node metastases at earlier stage, allowing more effective treatment

Ferrotran (formerly Combidex), based on Ferumoxtran-10, is the only contrast agent which can detect lymph node metastases as small as 2 mm diameter

Ferrotran (formerly Combidex), based on Ferumoxtran-10, is the only contrast agent which can detect lymph node metastases as small as 2 mm diameter. Standard MRI or CT are not able to detect lymph node metastases smaller than 7 – 8 mm. Since most of the oncologic patients are dying due to metastases, a precise diagnostic is of utmost importance. The detection of small metastases, combined with the very clear and contrast rich MRI image of Ferrotran, enables an earlier and more precise treatment. Therefore, Ferrotran gives the patient a much higher chance of recovery.

December 24, 2019 — SPL Medical announced today that the first patient has been successfully diagnosed with suspected lymph node metastases of prostate cancer with Ferrotran (Ferumoxtran) at the University Hospital Zurich. This follows approval (Sonderbewilligung acc. to Swiss AMBV) by Swissmedic to Universitätsspital Zurich, Institut für Diagnostische und Interventionelle Radiologie, for restricted use of Ferrotran under a compassionate use program. Ferrotran (Ferumoxtran) is a novel contrast agent for use in MRI (magnetic resonance imaging) developed for the detection of lymph node metastases of prostate cancer. It is the first contrast agent for the use in MRI that is able to identify metastases as small as 1.5 mm. The rise of prostate specific antigen (PSA) is often the first symptom of suspected recurrent lymph node metastases. Being able to detect small metastases in prostate cancer early enough should enable a better chance of successful treatment.

SPL Medical is the manufacturer of Ferrotran and responsible for the worldwide commercialization. The company is about to start a large multicenter trial of Ferrotran that will be conducted in 10 top radiology centers in Germany, Switzerland and the Netherlands, enrolling a total of 180 patients with prostatic cancer.

The development of Ferrotran was initially enabled and accelerated by Prof. Jelle Barentsz of the Radboud University Medical Center in Nijmegen, the Netherlands. He discovered the unique features of Ferrotran for the early detection of lymph node metastases when he used it as contrast agent for prostate cancer patients. So far, he has diagnosed metastases in more than 1,500 patients using this agent.

“We have built a vast experience with Ferrotran and have started to train radiologists from participating clinical centers to bring them up to speed with the latest use of the product and interpretation of the imaging results,” said Barentsz.

“Ferrotran represents a major opportunity to improve the diagnosis of lymph node metastases from prostate cancer, with patients subsequently having potentially better treatment outcomes and fewer side-effects,” stated Jürgen Feuerstein, M.D., chief executive officer of SPL Medical. “The compassionate use program at the University Hospital Zurich provides vital access for prostate cancer patients to this game-changing product. Meanwhile, at SPL Medical, we will continue advancing our clinical development plan to enable potential registration of Ferrotran.”

www.ferrotran.com

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