03 Mar FDA clears Cellectar's drug
MADISON – Cellectar, Inc., a privately held radiopharmaceuticals company that designs and develops products to detect, treat and monitor human cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its 131I-CLR1404 drug candidate for testing in patients with advanced solid malignancies. The company expects to begin phase I clinical studies in the second quarter of 2009.
The first phase I study will enroll up to 9 patients and will include drug dosimetry calculations and biodistribution assessments. The second phase I study will be a dose escalation study evaluating the Maximum Tolerated Dose (MTD) of 131I-CLR1404 in patients with advanced solid malignancies; both studies will be performed at four leading U.S. medical centers.
Cellectar’s President and CEO, Bill Clarke, M.D., commented, “We are extremely pleased to have received FDA clearance allowing us to advance our lead product candidate into human clinical studies. Further, we are hopeful that this novel anti-cancer compound, selectively retained by cancer cells, may provide benefit to solid tumor patients with few therapeutic options.”
Cellectar, Inc. is a radiopharmaceutical company that designs, develops and manufactures products to detect, treat and monitor a wide variety of human cancers. Cellectar’s product candidates combine lipid-like molecules, phospholipid ethers (PLEs) analogs, with radioisotopes that can either image or destroy malignant cells. Cellectar’s products’ mechanism of action is based on their accumulation and selective retention in malignant tumors and not in normal cells.