FDA clears Cellectar's IND application for drug candidate

Cellectar, Inc., a privately held radiopharmaceuticals company that designs and develops products to detect, treat and monitor human cancers, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its (131)I-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 (131)I-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."

About (131)I-CLR1404

Cellectar's (131)I-CLR1404 is a small-molecule, phospholipid ether analog that combines lipid-like properties with a cancer therapeutic beta-emitting radioisotope. Cellectar believes that this compound will benefit individuals with cancer due to its selective retention and accumulation in malignant cells versus nonmalignant cells. Preclinical animal studies demonstrated that (131)I-CLR1404 significantly slowed the growth of malignant solid tumors and resulted in improved survival. Non-radiolabeled CLR1404 proved safe at doses greater than 1000x the anticipated human dose.