On June 11, 2015, Cellectar Biosciences reported that, after review of the company’s investigational new drug (IND) application, the U.S. Food and Drug Administration (FDA) has determined that Cellectar’s tumor margin illumination agent, CLR1502, will be evaluated as a combination product and assigned to the Center for Devices and Radiological Health (CDRH) (Filing, 8-K, Cellectar Biosciences, JUN 11, 2015, View Source [SID:1234505396]). As a result of this classification, the FDA has advised Cellectar that it will need to submit a new investigational application for the combination product prior to initiating its planned proof-of-concept trial in breast cancer surgery.
"Our tumor illumination agent shares similar spectral qualities with indocyanine green (ICG), a fluorescent dye commonly used in medical diagnostics, and can therefore use several commercially available fluorescent imaging devices. Current labeling for such devices is limited to FDA approved applications such as cardiac, circulatory, hepatic and ophthalmic conditions," said Dr. Simon Pedder, president and chief executive officer of Cellectar Biosciences. "Because of the groundbreaking nature of our overall technology and the potential for an agent like CLR1502 to dramatically expand the utility of such imaging devices, we appreciate the agency’s perspective and current interest in evaluating CLR1502 in combination with a light source technology. As previously disclosed, in the course of our discussions FDA regarding the CLR1502 registration program, the FDA has stressed that a combination product designation is not binding, can be revised later in our development program, and that we are not necessarily precluded from filing a standalone NDA in the future."
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About CLR1502
CLR1502 is a small-molecule, broad-spectrum, cancer-targeted, non-radioactive optical imaging agent developed by Cellectar to be the first of its kind for broad spectrum intraoperative tumor margin illumination and non-invasive tumor imaging. CLR1502 is comprised of a proprietary phospholipid ether (PLE) analog, acting as a cancer-targeted delivery and retention vehicle attached to a fluorophore to enable real-time visualization of malignant tissue under near-infrared light.
CLR1502 is being developed for intraoperative imaging of cancer that will aid in the identification of malignant tissue during diagnostic, staging, debulking and curative cancer surgeries. In particular, the potential of CLR1502 in tumor margin illumination during oncologic resections raises the possibility that this operative aid may improve surgical outcomes.