Spago NanoMedical’s magnetic resonance imaging (MRI) contrast agent, SN132D, was well tolerated in patients with endometriosis, according to a preliminary analysis conducted by the company.
Although further evaluation of its MRI contrast-enhancing properties in lesions indicative of deep endometriosis is needed, Spago Nanomedical says the agent demonstrated a good safety profile.
The Phase IIa trial (NCT05664828) – called SPAGOPIX-02 – is an open-label, proof-of-concept study evaluating the safety and MRI-enhancing properties of SN132D in adult female patients with suspected endometrial lesions.
The company has paused recruitment, stating that the eight patients currently in the study are sufficient to provide a meaningful assessment.
As per the National Cancer Institute (NIH), the nanoparticle-based contrast agent has a polymeric core containing the paramagnetic contrast agent, manganese chloride tetrahydrate. The positively charged manganese ions are chelated to phosphate groups and covered with polyethylene glycol (PEG)-polymers – which can potentially increase contrast enhancement during MRI.
With the help of its nanoparticle constitution, the agent builds up in the tumour microenvironments (lesions), making lesions easier to spot during imaging.
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Endometriosis is becoming a better-understood disease, though the cause is unknown, and no cure currently exists. There are treatments; however, enhanced contrast agents would help spot lesions. The disease is thought to affect 10% of women, according to a UK endometriosis organisation.
Spago Nanomedical’s agent is already being used to enhance contrast for breast cancer tumours (NCT04080024).
“We are pleased SN132D continues to show good safety, which is important for all development programs involving our platform material. We look forward to the conclusions of the full analysis of the study results so far, which will provide an important basis for decision on further development of the program,” said Mats Hansen, Spago Nanomedical’s CEO.