Second dose group fully recruited in Spago Nanomedical’s phase 1 study with SpagoPix
Spago Nanomedical AB (publ) today annouced that all patients have been recruited in the second dose group in the company's ongoing clinical phase I study SPAGOPIX-01 with the tumor-selective contrast agent SpagoPix (SND132D). New interim results are expected to be reported in early 2022.
A total of 6 patients with confirmed breast cancer have been included in the second dose group in the phase I study SPAGOPIX-01, which has been performed at two hospitals in Sweden. A number of adjustments to the study protocol have been made during the course of the study to, among other things, broaden the patient base and simplify the inclusion of patients. Including the 6 patients included in the first dose group, a total of 12 patients were evaluated in the study.
”It is very gratifying that we have now completed the recruitment and can start analyzing the results from the second patient group who received a higher dose of our tumor selective contrast agent SND132D”, said Mats Hansen, CEO of Spago Nanomedical. ”We have seen that SND132D is well tolerated by patients in lower doses, where early signals of contrast enhancement have also been shown. It will be exciting to get the results from the analysis of this dose group at the beginning of next year.”
The primary endpoint of the study is to study safety at different doses of SN132D. Secondary endpoints include initially investigating how the contrast agent can enhance MRI images in clinical use in patients with solid tumors of the breast, as well as the liver and the pancreas.
Previous interim results from the study have shown a good safety profile and clear contrast in MRI images of breast tumors at the current dose. Furthermore, all images in the study showed a very good contrast in the pancreas and in the liver.