Madison, WI (Press Release) - Cellectar Biosciences, Inc. (Nasdaq: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."

About Multiple Myeloma

According to the National Cancer In­sti­tute, mul­ti­ple myeloma is the sec­ond most common hema­to­logic cancer and results from an ab­nor­mal­ity of plasma cells, usually in the bone mar­row. It is esti­mated that 70,000 people are living with mul­ti­ple myeloma and 24,000 new cases are diag­nosed annually in the U.S., and that nearly 230,000 people are living with mul­ti­ple myeloma and approx­i­mately 114,000 new cases are diag­nosed annually, world­wide.

About Cellectar Biosciences, Inc.

Cellectar Biosciences is devel­op­ing agents to detect, treat and monitor a broad spectrum of cancers. Using a novel phos­pho­lipid ether analog (PLE) plat­form tech­nology as a targeted de­livery and retention vehicle, Cellectar's com­pounds are de­signed to be sel­ectively taken up and retained in cancer cells in­­clud­ing cancer stem cells. With the ability to attach both imaging and thera­peutic agents to its pro­pri­e­tary de­livery plat­form, Cellectar has devel­oped a port­folio of prod­uct can­di­dates engi­neered to leverage the unique char­ac­ter­istics of cancer cells to "find, treat and follow" malig­nan­cies in a highly sel­ective way. I-124-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted PET imaging agent cur­rently being eval­u­ated in a Phase II glio­blas­toma imaging trial. Addi­tionally, mul­ti­ple in­ves­ti­ga­tor-sponsored Phase I/II clin­i­cal trials are on­go­ing across 11 solid tumor indi­ca­tions. I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that de­livers cytotoxic radi­a­tion directly and sel­ectively to cancer cells in­­clud­ing cancer stem cells. A Phase Ib dose-escalation trial of I-131-CLR1404 in patients with ad­vanced solid tumors was com­pleted in the first quarter of 2014 and results pre­sented at the American Society of Clinical Oncology (ASCO) 2014 Annual Meeting. CLR1502 is a pre­clin­i­cal, cancer-targeted, non-radioactive optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. For addi­tional in­for­ma­tion please visit www.cellectar.com

This news re­lease con­tains for­ward-looking state­ments. You can identify these state­ments by our use of words such as "may," "expect," "be­lieve," "antic­i­pate," "intend," "could," "esti­mate," "con­tinue," "plans," or their neg­a­tives or cognates. These state­ments are only esti­mates and predictions and are subject to known and unknown risks and un­cer­tain­ties that may cause actual future ex­peri­ence and results to differ ma­teri­ally from the state­ments made. These state­ments are based on our cur­rent beliefs and ex­pec­ta­tions as to such future out­comes. Drug discovery and devel­op­ment in­volve a high degree of risk. Factors that might cause such a ma­teri­al dif­fer­ence in­clude, among others, un­cer­tain­ties re­lated to the ability to raise addi­tional capital, un­cer­tain­ties re­lated to the ability to attract and retain part­ners for our tech­nolo­gies, the identi­fi­ca­tion of lead com­pounds, the suc­cess­ful pre­clin­i­cal devel­op­ment thereof, the com­ple­tion of clin­i­cal trials, the FDA review process and other gov­ern­ment reg­u­la­tion, our pharma­ceu­tical col­lab­o­rators' ability to suc­cess­fully de­vel­op and com­mer­cial­ize drug can­di­dates, com­pe­ti­tion from other pharma­ceu­tical com­pa­nies, prod­uct pricing and third-party reim­burse­ment. A com­plete description of risks and un­cer­tain­ties re­lated to our business is con­tained in our periodic reports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion in­­clud­ing our Form 10-K for the year ended De­cem­ber 31, 2013. These for­ward-looking state­ments are made only as of the date hereof, and we disclaim any obli­ga­tion to up­date any such for­ward-looking state­ments.

Source: Cellectar Biosciences, Inc.