Spago Nanomedical has received regulatory approval to initiate a Phase IIa clinical study with its MRI contrast agent SN132D in endometriosis.
Patient recruitment has started, and the first patient is expected to be dosed shortly. The ongoing SPAGOPIX-01 study in breast cancer has now been concluded and a final report is in preparation, states the company.
“We are very pleased that SPAGOPIX-01 meets the primary objectives set out for the study and that the results with SpagoPix in breast cancer provide a clinical validation of our nanomedical platform. Based on ongoing discussions with potential partners and experts in the field, we have decided to focus our resources within the SpagoPix program on endometriosis, a severely undertreated disease affecting up to 10 percent of women of reproductive age,” says Mats Hansen, CEO at Spago Nanomedical. “Endometriosis represents a very large indication of major unmet medical need for better imaging diagnostics which current contrast agents and other diagnostics are not able to fulfill.”
About the trial
The Phase IIa clinical trial in endometriosis is an open label, proof-of-concept study concerning efficacy of the novel intravenous contrast agent SN132D in patients with suspected endometriosis. The study will include up to 18 patients and led by Associate Professor Dr. Ligita Jokubkiene, Senior Consultant at the Department of Obstetrics and Gynecology at Skåne University Hospital in Malmö, Sweden.
The study will evaluate the safety and MRI enhancing properties of SN132D in participants with suspected endometriosis. Comparisons will be made to transvaginal ultrasound and conventional MRI in order to consider the diagnostic potential of SN132D in endometriosis.
The SPAGOPIX-01 study in breast cancer
The SPAGOPIX-01 study in breast cancer was conducted at two hospitals in Sweden with the primary objective of studying safety at different doses of SN132D. A total of 14 patients with confirmed breast cancer were enrolled and dosed. The initial results from the study will be presented at the 2022 San Antonio Breast Cancer Symposium and the final report of the study is in preparation.
Photo: Spago Nanomedical