Spago Nanomedical has completed the studies in the regulatory preclinical program with its leading candidate drug Tumorad (SN201).
It displays a good safety margin to clinically relevant doses, states the company.
“The completion of the regulatory preclinical studies is an important step towards the clinical development phase. The preparations for the first study with SN201 in humans are proceeding according to plan and we expect to be ready to start phase I/II in next year ,” says CEO Mats Hansen.
The preclinical package included toxicology- and dosimetry-studies in rat. The results showed that the nanomaterial is safe to give in doses that widely exceed planned clinical doses, and that radiation is distributed in the body in a manner that allow dosing according to plan.
“The results confirm the data we previously have seen in pilot studies and mean that we with confidence can proceed with SN201 to the clinic. This is a major risk reduction in the project,” says Oskar Axelsson, CSO at Spago Nanomedical.
The first clinical trial application with Tumorad
Data from the preclinical studies, together with other documentation, will form the basis for the first clinical trial application with Tumorad. The plan is to submit the application and start the studies in humans in 2022. The aim for the clinical study is to document safety at different doses of Tumorad in cancer patients as well as to evaluate signs of early proof-of-concept.
The preclinical regulatory program, conducted in collaboration with Charles River Laboratories and Minerva Imaging, included both toxicity and dosimetry studies.
Image: Tumorad. Photo: Emil Aaltonen