Cyclotek would like to extend our congratulations to the team at Spago Nanomedical AB on the first administration of Lu177-SN201, in a world first Phase I/IIa clinical trial.
This milestone represents the culmination of years of international collaborative effort from the Spago Nanomedical team, and Cyclotek is both proud and humbled to participate as manufacturing partner to supply the Lu177-SN201 product.
Lu177-SN201 is a promising new radionuclide therapy for the tumour-selective treatment of advanced cancer. Following radiolabelling with therapeutic radionuclide Lu-177, Spago Nanomedical’s proprietary nanoparticles are injected into the patient and selectively accumulate in the tumour via the Enhanced Permeability and Retention (EPR) effect.
Cyclotek’s Product Development and Implementation (PDI) team developed the automated synthesis method for the production of Lu177-SN201 in collaboration with Spago Nanomedical, and coordinated supply of the product from Melbourne to the trial site in Adelaide. Cyclotek’s PDI Manager, Mathew Heald, said following the first successful patient dose “We were delighted to have been chosen to partner with Spago Nanomedical and translate Lu177-SN201 onto our synthesis platform. This project exemplifies our commitment to providing cutting-edge manufacturing solutions that contribute to innovative breakthroughs in healthcare. The development team at Spago Nanomedical were highly engaged and receptive throughout the development process.”
The Phase I/IIa trial entitled Tumorad-01 aims to assess the safety, biodistribution and possible therapeutic dose of Lu177-SN201. Current clinical sites include St Vincent’s Hospital Melbourne and Cancer Research South Australia, where the world first administration of Lu177-SN201 took place. Following the first-in-human administration, Spago Nanomedical’s Chief Development Officer, Paul Hargraves, stated “The study start marks the transition into clinical development of Tumorad and is a very important milestone for Spago Nanomedical”.
This significant milestone is a triumph for the team at Spago Nanomedical, and represents a significant step forward for patients who have advanced solid cancers with limited treatment options. Cyclotek CEO Greg Santamaria noted “This successful international collaboration highlights Australia’s sovereign radiopharmaceutical development capabilities, and we look forward to continuing to manufacture and supply Lu177-SN201 throughout the trial.”
For more information on Spago Nanomedical AB, visit their website: