Illuminare Biotechnologies, a US-based privately held biotechnology company, announced on Monday that it has dosed its first subject in the phase one trial of Illuminare-1.
The product is being developed to improve the visualisation and delineation of critical nerve structures intra-operatively in real time with the intention of avoiding serious, and potentially permanent, unintended nerve injury.
The first-in-human clinical trial is being carried out at Memorial Sloan Kettering Cancer Center (MSK), jointly with collaborators from Illuminare Biotechnologies, in subjects undergoing robot-assisted radical prostatectomy.
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. The US FDA has granted Fast Track Designation to Illuminare-1.
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