Phase I 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 first-in human clinical trial will be conducted at Memorial Sloan Kettering Cancer Center, along with collaborators from Illuminare Biotechnologies.

The Phase 1 trial of Illuminare-1 is a dose-escalation study in up to 50 patients undergoing robot-assisted radical prostatectomy. The primary objective of the Phase 1 trial is safety and secondary objectives include determination of the human pharmacokinetics of Illuminare-1 and selection of optimal dose based on fluorescence to advance in the clinic.

Timothy Donahue, MD, is the lead investigator for the first-in-human clinical trial and Associate Attending Surgeon in the Urology Service at Memorial Sloan Kettering Cancer Center. Peter Scardino, MD, David H. Koch Chair, and Vincent Laudone, MD, Chief of Surgery at Josie Robertson Surgery Center are co-principal investigators.

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