Spago Nanomedical AB has achieved a significant milestone in medical imaging advancement with the acceptance of their clinical trial results for publication in the prestigious journal Investigative Radiology. The study, focusing on their novel contrast agent pegfosimer manganese, demonstrates promising results in enhancing magnetic resonance imaging (MRI) visualization of breast cancer tumors.
The manuscript, titled "Safety, Tolerability, Efficacy and Pharmacokinetics of Pegfosimer manganese (SN132D) for Contrast Enhanced MRI of Breast Cancer," will be featured in the September 2025 issue, highlighting the product's clinical potential in cancer diagnostics.
Clinical Trial Outcomes
The SPAGOPIX-01 trial (NCT04080024) revealed that pegfosimer manganese, previously known as SN132D, successfully achieved its primary objectives. The contrast agent demonstrated:
- Acceptable safety profile in study participants
- Clinically relevant contrast enhancement in primary breast cancer tumors
- Potential application in improving MRI precision for cancer detection
Broader Applications and Development
Beyond breast cancer imaging, the SpagoPix development program has shown promising results in other applications:
- Successful contrast enhancement observed in endometriosis lesions during a Phase IIa study (NCT05664828)
- Potential for improved visualization of various tumors and lesions
- Development of a selective contrast agent for more precise diagnostic imaging
"A publication in one of the leading scientific journals in the medical imaging field is a strong validation of the extensive clinical development work behind the SpagoPix program," stated Mats Hansen, CEO of Spago Nanomedical. "The publication also supports our ongoing business development work aimed at finding potential partners or other solutions for further development of the program."
Future Development Strategy
The company has outlined its strategy for advancing the SpagoPix program:
- Seeking partnerships or commercial collaborations for continued clinical development
- Exploring licensing opportunities
- Pursuing external financing options to support further research
The technology builds on Spago Nanomedical's platform of polymeric materials, designed to enable more precise treatment and diagnosis of cancer and other serious diseases. This advancement represents a significant step forward in the field of medical imaging, potentially offering healthcare providers enhanced diagnostic capabilities for more accurate disease detection and treatment planning.