FDA clears Cellectar cancer biomarker for trial

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Cellectar has received FDA investigational new drug application clearance for its 131I-CLR1404 drug candidate for testing in patients with advanced solid malignancies.

he Madison, Wis.-based company said it 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 131I-CLR1404 is a small-molecule, phospholipid ether analog that combines lipid-like properties with a beta-emitting radioisotope. Cellectar said that the compound will benefit individuals with cancer due to its selective retention and accumulation in malignant cells versus nonmalignant cells.