Cellectar Biosciences Announces Acceptance of Investigational New Drug Application to Evaluate I-131-CLR1404 in Clinical Trials in Relapsed or Refractory Multiple Myeloma
MADISON, Wis., Sept. 4, 2014 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (CLRB), announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company's investigational new drug (IND) application to begin clinical study of I-131-CLR1404, a highly-selective, cancer-targeting radiopharmaceutical, in patients with relapsed or refractory multiple myeloma, an incurable cancer of plasma cells.
I-131-CLR1404 is radiotherapeutic comprised of a proprietary phospholipid ether (PLE) analog, acting as a cancer-targeted delivery and retention vehicle, covalently labeled with Iodine-131, a cytotoxic radioisotope that is already commonly used to treat thyroid and other cancer types. Because Cellectar's PLE platform has been shown to reliably and universally accumulate in malignant cancer cells, and the therapeutic properties of the Iodine-131 isotope are well known, I-131-CLR1404 is engineered to combine an intracellular radiation mechanism of destroying cancer cells, including cancer stem cells, through targeted delivery specific to malignant tissue that spares critical normal tissues from consequential radiation dose.
Cellectar plans to initiate a Phase I/II, proof-of-concept trial during the fourth quarter 2014 in approximately 20 patients with relapsed or refractory multiple myeloma that have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor. The primary objective of the study will be to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone. In addition, the trial will seek to identify the recommended dose for future pivotal trials and determine therapeutic activity of I-131-CLR1404 in this patient population as measured by overall response rate, time to progression and duration of response.
"This trial affords us an opportunity to both assess the safety of I-131-CLR1404 in patients with multiple myeloma, but also to obtain near-term proof-of-concept data characterizing the activity of I-131-CLR1404 in this difficult-to-treat patient population," commented Dr. Simon Pedder, president and chief executive officer. "Having initiated a Phase II diagnostic imaging trial of our lead compound, I-124-CLR1404, in glioblastoma earlier in the year, we are pleased to now have this opportunity to initiate a second, company-sponsored clinical trial with the potential to showcase the therapeutic applications of our targeted delivery platform."
