Licensing agreement reached for contrast agent for use in patients with prostate cancer

"The 2 agreements mark the start of a new product line," said Sanochemia Managing Director Thomas Erkinger in a news release.

Sanochemia Pharmazeutika announced that it has secured exclusive licensing rights to a new MRI contrast agent based on ferumoxtran, which is currently in an advanced phase 3 pivotal trial (NCT04261777) and may be used to detect the smallest lymph node metastases in patients with prostate cancer.¹

The agent is already in use in the Netherlands under an authorized Named-Patient-Use-Program.

The agreement that was made with SPL Medical grants Sanochemia exclusive worldwide rights for parts of the manufacture and global distribution of the agent with the exception of Germany, Austria, and Switzerland. A late phase 3 trial evaluating the agent is underway at several clinics in Europe. The agent, which will carry the registered trademark Ferrotran, contains iron-based superparamagnetic nanoparticles and is intended to be used to detect lymph node metastases in patients with prostate cancer, although research is also evaluating the possible use of the agent in other types of cancer.

"The 2 agreements mark the start of a new product line," said Sanochemia Managing Director Thomas Erkinger in a news release.¹ "We are striving to play a pioneering role in the field of gadolinium-free MRI contrast agents. Innovative specialties optimally complement our classic product line in diagnostic imaging.”

"We are gaining access to the worldwide market of medical imaging via the extensive marketing network of Sanochemia,” said Dr. Jürgen Feuerstein, CEO of licensor SPL Medical, in the release.¹ “Within an authorized named-patient-use-program, more than 700 prostate cancer patients have already been diagnosed in Nijmegen with ferumoxtran in the Netherlands, enabling them to receive earlier and more specific treatment and a significantly higher chance of recovery. The earlier affected lymph nodes are detected, the better the chances of recovery with targeted, less invasive treatment."

The primary outcome measure of the phase 3 trial is lymph node metastases detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced). “True positive fraction and false positive fraction of identified tumor tissue in pelvic lymph nodes will be analyzed by histopathology as established reference method,” according to the study’s entry on ClinicalTrials.gov.² Secondary outcome measures include number and regions of lymph node metastases present in the follow-up MRI in comparison with pre-surgery MRI (unenhanced and ferumoxtran-enhanced), frequency of occurrence and severity of abnormal findings in safety investigations, and percentage of participants for whom the patient management plan would be changed based on the ferumoxtran-enhanced MRI.²

REFERENCES

1. Sanochemia: New contrast agent aims to detect the smallest lymphatic metastases in prostate cancer. News release. Sanochemia Pharmazeutika. April 17, 2024. Accessed April 30, 2024. https://www.prnewswire.com/news-releases/sanochemia-new-contrast-agent-aims-to-detect-the-smallest-lymphatic-metastases-in-prostate-cancer-302119286.html

2. Ferumoxtran-10-enhanced MRI in prostate cancer patients. ClinicalTrials.gov. Update May 8, 2023. Accessed April 30, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04261777