Cellectar's in-house capabilities now meet good manufacturing practice (GMP) requirements and the company can now initiate its clinical trials, as well as develop and manufacture new radiopharmaceuticals beyond its lead cancer radioisotope.
Its drug candidate, CLR1404, is a phospholipid ether analog radiolabeled with iodine-131, commonly used to treat cancer. In pre-clinical evaluations, CLR1404 has shown the ability to carry the potent isotope inside malignant cells and destroy them without adversely affecting healthy tissues. Human trials will begin later this year following submission and FDA review of its investigational new drug application, the Madison, Wis.-based company said.
Cellectar said its initial clinical trial will focus on assessing safety and appropriate dosing in the treatment of a variety of solid tumors.