Novel Nerve Visualization Investigational Fluorophore Receives FDA IND Approval for First-In-Human Trial

NEW YORK, April 15, 2021 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Illuminare-1, a small molecule, myelin binding agent, for their Investigational New Drug Application (IND). Illuminare-1 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 (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.

"This is an important first step 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 so we are eager to begin 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.

About Illuminare-1

Illuminare-1 is a single dose injectable myelin binding fluorescent agent currently in development by Illuminare Biotechnologies, in collaboration with Memorial Sloan Kettering Cancer Center, to provide real time visualization and delineation of nerves as small as ~60 micron during both open and minimally invasive surgery under blue light illumination. The agent has an immediate onset of action and a duration of activity between 4-5 hours. Safety has been established in animal models.

About Illuminare Biotechnologies

Illuminare Biotechnologies is a privately held biotechnology company founded in 2016 to develop Illuminare-1.  www.illuminarebio.com.

Memorial Sloan Kettering (MSK) has institutional financial interests related to the research noted in this release in the form of intellectual property rights and associated interests by virtue of licensing agreements between MSK and Illuminare.

SOURCE Illuminare Biotechnologies, Inc.