24 May, 2018

SpagoPix shows good safety in regulatory preclinical studies

Spago Nanomedical AB (publ) has completed the in-life part of the regulatory preclinical program with SpagoPix. The product candidate SN132D displays a good safety margin to clinically relevant doses.

Data from the preclinical studies will be included in the regulatory application for the first clinical trial with SpagoPix. The aim is to submit the application in order to allow a study in humans to start during this year. The planned clinical study will be performed in cancer patients and is being designed to document safety and MR images of tumors.

”We are currently working with the detailed design of the first study with SpagoPix in humans. The aim is to commence the clinical trial at the end of this year”, says Mats Hansen, CEO of Spago Nanomedical.

”The results of the preclinical studies confirm the data previously seen in pilot studies and we are confident that SN132D is safe to use in clinically relevant doses. This is a major risk reduction in the SpagoPix project”, says Oskar Axelsson, CSO of Spago Nanomedical.

The regulatory preclinical program has been conducted in collaboration with Charles River Laboratories and included extensive toxicity- and safety studies.