Additional Relevant Details The study demonstrated that a single dose of CLR 125 reduced the volume of human-derived primary triple negative breast cancer xenografts (tumor models) by approximately 60 percent, compared to a control vehicle (p<0.001), as well as significantly extending survival. CLR 125 also significantly weakened the progression of micrometastases (p< 0.01) and reduced established metastases (p< 0.01) compared to the control vehicle.  Importantly, within 96 hours of dosing, investigators observed that radioactivity cleared from subjects' blood and organs and accumulated primarily in the tumor cells where it was retained past 144 hours.
"These study results provide further validation of the benefits of our Phospholipid Drug Conjugate (PDC) development program, whether in cytotoxics, as in our previously announced paclitaxel program or radiotherapeutics, as this study demonstrated," said Jim Caruso, president and CEO of Cellectar Biosciences.  "Further, these data clearly show that our PDC delivery platform may possess clinical utility in a broad range of cancer types with a wide variety of cytotoxic compounds."This trial represents the first phase of the SBIR contract for a Phase 1 study sponsored by NCI. Following a complete review of the data, an assessment of potential clinical applications, and differentiated product benefits, both NCI and the company will determine whether to advance CLR 125 into phase 2 of the contract.