7 December, 2016
The final formulation of the tumor-selective contrast agent SpagoPix has been biologically verified and fulfills the company criteria regarding tolerability and toxicity in pilot studies. SpagoPix is now ready for further development in regulatory studies.
SpagoPix is a contrast agent that selectively accumulates in tumors and facilitates cancer diagnostics by magnetic resonance imaging (MRI). The establishment of the physico-chemical properties of the active ingredient of SpagoPix earlier this year was a major step for the project and the most significant company milestone that far. The present step means that also the final formulation of the contrast agent, i.e. the solution that will be administered by injection, has been established.
”The final formulation of SpagoPix has passed the needle´s eye before regulatory tests in animals and humans. In addition, it is also very satisfactory that we now have ongoing production to supply the regulatory preclinical program”, says Oskar Axelsson, CSO of Spago Nanomedical.
The product candidate (SN132D) will be tested in regulatory GLP-studies to document safety and pharmacokinetics prior to the first clinical study. The preclinical program will be conducted externally by a contract research organization (CRO).
”This is yet another major step for the company. The fact that we now have a material that is ready for regulatory development means a significant risk reduction for the SpagoPix-project”, says Mats Hansen, CEO of Spago Nanomedical.