October 22, 2009 Lincoln, NE, U.S.A. and Berlin, Germany: LI-COR Biosciences presented preclinical data on its investigational IRDye 800CW carboxylate, which is being developed for potential use in clinical applications. To prepare for clinical use as a near-infrared (NIR) fluorophore, a safety study was conducted on IRDye 800CW carboxylate with Sprague Dawley rats. Michael Olive, LI-COR vice president of science and technology, presented the findings of the study at the Global Imaging Summit in Berlin.
"With the current environment of NIR fluorescence instrument development, IRDye 800CW could impact molecular imaging by providing a functionalized NIR dye enabling a variety of new targeting contrast agents," reports Olive. "Based on hematologic and clinical chemistry evaluations, and histopathologic evaluation of tissues from animals in this study, single administration of IRDye 800CW carboxylate intravenously at dose levels of 1, 5 and 20 mg/kg or 20 mg/kg intradermally followed by up to 14 days of observation produced no pathological evidence of toxicity."
LI-COR is preparing to submit a Drug Master File on IRDye 800CW to the U.S. Food and Drug Administration. LI-COR anticipates having dye made in compliance with cGMP and available for clinical studies in early 2010.
Optical imaging using near-infrared fluorophores has the potential for use in endoscopy, intraoperative surgical guidance, and imaging the lymphovascular system.