Nanexa receives approval to start clinical trial with NEX-20
Nanexa AB (publ) today announced that it has received approval from the Swedish Medical Products Agency to initiate a clinical trial of its drug candidate NEX-20, a long-acting formulation of lenalidomide, based on the PharmaShell® system, intended for the maintenance treatment of multiple myeloma cancer.
The study is a Phase 1 trial to study the pharmacokinetic profile, safety and tolerability of NEX-20, in ascending doses in healthy volunteers. Approval from the Ethics Review Board (etikprövningsnämnden) has already been obtained and other activities to start the study are on track.
"The approval is a major and important milestone for Nanexa as it is the first clinical study in the NEX-20 project. It means that we can now start the NEX-20 study on schedule and take our second drug based on PharmaShell into the clinic. We are now getting ready to start the study and expect to have the first results from the study in the first quarter of next year", says David Westberg.
