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.
Personalis validates NeXT Personal test for ultra-sensitive MRD detection
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
Lipocine doses first cohort in LPCN 1154 study
Poseida Therapeutics names new chief medical officer
Biocytogen and ABL Bio collaborate on development of new bispecific antibody-drug conjugates