Spago Nanomedical AB (publ) announces today that a preliminary analysis of data from the phase IIa clinical study SPAGOPIX-02 shows that SN132D has a good safety profile in patients with endometriosis. Further evaluation of the MRI contrast enhancing properties, particularly in lesions indicative of deep endometriosis, is ongoing.
SPAGOPIX-02 is an open-label, proof-of-concept study to evaluate the safety and MRI-enhancing properties of SN132D in patients with suspected endometriosis. The first preliminary results have been compiled and analysed by the study Data Monitoring Committee. It was concluded SN132D is well tolerated in patients with endometriosis and that further analysis is needed before conclusions about efficacy can be made. The Committee further concluded the number of recruited patients (n=8) at this point is sufficient to provide for a meaningful assessment and recruitment is therefore paused.
“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” says Mats Hansen, CEO of Spago Nanomedical.
The contrast agent SN132D has previously been evaluated in the phase I clinical study SPAGOPIX-01 in patients with confirmed breast cancer. Initial results from the study show that SN132D is well tolerated and provides clear contrast in MRI images of solid tumors in the breast, as well as in the pancreas and liver. Final report of the study is in preparation.