Spago Nanomedical AB (publ) today announced that preliminary analysis of data from the phase IIa clinical study SPAGOPIX-02 showed that SN132D has a favorable safety profile in patients with endometriosis. Further evaluation of the contrast enhancing properties of MRI, particularly in lesions indicating deep endometriosis, is ongoing.
SPAGOPIX-02 is an open label proof of concept study to evaluate the safety and enhancing properties of SN132D MRI in patients with suspected endometriosis. The first preliminary results were compiled and analyzed by the study’s Data Monitoring Committee. In conclusion SN132D is well tolerated in patients with endometriosis and further analysis is needed before conclusions about efficacy can be made. The committee further concluded the number of patients recruited (n = 8) at this time was sufficient to provide a meaningful assessment and recruitment was therefore suspended.
“We are pleased that SN132D continues to demonstrate good safety, which is important for all development programs involving our platform materials. We look forward to the conclusion of the full analysis of the study results so far which will provide an important basis for further program development decisions.” 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. Preliminary results from the study indicated that SN132D was well tolerated and provided a clear contrast on MRI images of solid tumors in the breast, as well as in the pancreas and liver. The final research report is in preparation.