First-in-Human Clinical Trial
Illuminare-1, a small molecule, myelin binding agent, is being developed as a surgical adjunct to improve the visualization and delineation of critical nerve structures intra-operatively in real time with the aim of avoiding serious, and potentially permanent, unintended nerve injury. The Phase 1 clinical trial was completed at Memorial Sloan Kettering Cancer Center, along with collaborators from Illuminare Biotechnologies.
This First-in-Human trial of Illuminare-1 was a dose-escalation study including 38 patients undergoing robot-assisted radical prostatectomy. The Phase 1 trial met the primary objective of demonstrating safety and also met secondary objectives including determination of the human pharmacokinetics of Illuminare-1 and selection of optimal dose based on observed nerve fluorescence to advance to Phase 2 in the clinic. Results of the Phase 1 trial were published on July 2025 in world-renowned JAMA Surgery. The article was accompanied by an invited editorial commentary.
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