Cellectar, Inc. announced that the US 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 1 clinical studies in studies in the second quarter of 2009.
The first phase 1 study will enroll up to nine patients and will include drug dosimetry calculations and biodistribution assessments. The second phase 1 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 US 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.’
Release Date: March 3, 2009