Collective data from recently completed toxicity studies show that the product candidate SN132D can be given safely at doses that widely exceeds the expected clinical dose.
At the end of 2016, Spago Nanomedical formally announced its product candidate in the SpagoPix project. The product candidate, designated SN132D, has now been investigated in several preclinical pilot studies in order to reduce risk and prepare for the regulatory safety program prior to clinical studies.
The pilot studies has been performed as a series of in vivo experiments where acute- and sub-acute toxicology has been investigated at different doses of SN132D. Analyses includes e.g. hematological factors, as well as histological evaluation of vital organs. All data from the pilot studies collectively support the safety of SN132D at doses that widely exceed the expected clinical dose.
SN132D has also been subject to pilot testing in a cell-based system for mutagenicity, known as Ames test, where SN132D were significantly free of genotoxicity.