Tuesday, February 7, 2023

561.316.3330

Biotechnology News Magazine

Illuminare Biotechnologies Announces First Participant Dosed in Phase I Study of Novel Nerve Visualization Investigational Fluorophore

Latest Posts

Nectin Therapeutics to Collaborate with Merck on Clinical Trial of Anti-PVR Antibody NTX1088 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Locally Advanced and...

NTX1088 is a First-in-Class and highly potent monoclonal antibody directed against PVR (CD155), a transmembrane protein expressed on cancer cells and associated with resistance to PD1 and PDL1 immune checkpoint inhibitors.

TransCure bioServices Offers BioVolume 3D Imaging for Insightful Preclinical Oncology Research

BioVolume reconstructs tumors from 3D, RGB, and thermal imaging. The solution is non-invasive, using a machine learning algorithm to automatically calculate subcutaneous tumor length, height, and width.

CLINUVEL Drug Significantly Reduces UV Skin Damage

“Today’s results build upon the decades of research CLINUVEL has conducted into the use of afamelanotide to protect skin from light, with the first evidence that a single dose of the drug has a photoprotective effect in healthy volunteers. These data add to our regulatory dossier for XP while further developing our specialised healthcare products for wider populations at highest risk of UV-induced damage and skin cancer,” Dr Bilbao said.

Deciphex Completes Validation Activities Enabling Veterinary Consultant Pathologists to Perform CLP Peer Review Digitally Using Patholytix

GLP and non-GLP studies can now be digitally peer reviewed by consultant pathologists for CROs and Pharma companies leading to faster study review and reduced backlogs with Drug candidates brought to clinical trials sooner advises Deciphex.

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.

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine