Illuminare Biotechnologies today announced the dosing of the first participant in the Phase I trial of Illuminare-1. Illuminare-1 is being developed 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 is being conducted at Memorial Sloan Kettering Cancer Center (MSK), along with collaborators from Illuminare Biotechnologies, in patients undergoing robot-assisted radical prostatectomy.
Surgery plays a prominent role as first line treatment across many medical conditions. The ultimate goal of surgery is to repair or remove damaged and/or diseased tissue while preserving vital structures, including nerves. Even with advanced surgical techniques, unintended nerve injury remains a leading cause of morbidity across many common surgical procedures, including prostatectomy, herniorrhaphy, thyroidectomy, lumpectomy, mastectomy, hip and knee replacement, vascular bypass, colorectal surgery and gynecologic surgery amongst others. Complications of nerve injuries are often permanent and may result in loss of function, sensation, muscle atrophy, pain, chronic neuropathy, reduced quality of life, disability, and paralysis.
“Dosing the first participant in the Phase I trial is an important milestone for this agent, one that we hope will ultimately lead to a reduction in unintended nerve injuries during surgery,” said Timothy Donahue, MD, lead investigator of the clinical trial and Associate Attending Surgeon in the Urology Service at MSK. “At MSK we are focused on how we can lessen the burden of cancer treatment on our patients and we are eager to expand enrollment into this trial.”
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. FDA has granted Fast Track Designation to Illuminare-1. The FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs which address high unmet medical needs in the treatment of serious or life-threatening conditions. The stated purpose of the designation is “to get important new drugs to the patient earlier”.
Illuminare-1 is a single dose injectable myelin binding fluorescent agent currently in development by Illuminare Biotechnologies, in collaboration with MSK, to provide real time visualization and delineation of nerves potentially as small as ~60 micron during both open and minimally invasive surgery under blue light illumination. The agent has been shown in animal studies to have an immediate onset of action and a duration of activity between 4-5 hours. Safety has been established in animal models.