Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clin­i­cal stage bio­phar­ma­ceu­tical com­pany devel­op­ing inno­va­tive agents for the detection and treat­ment of cancer, an­nounced the ini­ti­a­tion of patient dosing in a proof-of-concept trial of I-131-CLR1404 in patients with re­lapsed or re­frac­tory mul­tiple myeloma, an indi­ca­tion for which I-131-CLR1404 pre­vi­ously re­ceived orphan drug desig­na­tion from the U.S. Food and Drug Admin­istra­tion.

Multiple myeloma is an incurable malig­nan­cy for which novel ther­a­pies are needed. The radiosensitivity of mul­ti­ple myeloma is well doc­u­mented. I-131-CLR1404 is de­signed to allow for targeted de­livery of ionizing radi­a­tion to malignant cells, allow­ing for an intracellular radi­a­tion mech­a­nism of cancer cell kill­ing re­gard­less of anatomic dis­tri­bu­tion.

"We are ex­cited to be devel­op­ing a new treat­ment op­tion for this dif­fi­cult dis­ease. Because of its unique mech­a­nism of action, I-131-CLR1404 may rep­re­sent an entirely dif­fer­en­t treat­ment ap­proach for patients that are no longer responding to cur­rently avail­able ther­a­pies," commented Dr. Natalie Callander, prin­ci­pal in­ves­ti­gator of Cellectar's I-131-CLR1404 mul­ti­ple myeloma trial, Asso­ci­ate Pro­fessor of Medicine, and Director, University of Wisconsin Carbone Cancer Center Myeloma Clinical Program. "I-131-CLR1404 appears to be a promising inves­ti­ga­tional drug and pre-clinical data in­di­cate that the com­bi­na­tion of Cellectar's cancer-selective de­livery and retention plat­form with a known radiotherapeutic could be highly ef­fec­tive in treating mul­ti­ple myeloma. We look for­ward to work­ing with Cellectar and other in­ves­ti­ga­tors to explore the poten­tial of I-131-CLR1404 as a treat­ment for re­lapsed or re­frac­tory mul­ti­ple myeloma."

This is a multi-center, open-label, sequential group, dose escalation, Phase I proof-of-concept study eval­u­at­ing the safety and tol­er­a­bil­ity of I-131-CLR1404, with and without concurrent weekly dexa­meth­a­sone, in mul­ti­ple myeloma patients who have pre­vi­ously been treated with, or are intolerant of, an immuno­mod­u­lator and a pro­te­a­some in­hib­i­tor. The sec­ond­ary objectives of the study are to identify a rec­om­mended Phase II dose and assess thera­peutic ac­­tiv­ity of I-131-CLR1404 in re­lapsed or re­frac­tory mul­ti­ple myeloma. Ther­a­peutic ac­­tiv­ity will be assessed by over­all re­sponse rate, time to pro­gres­sion and duration of re­sponse.

Patients will be en­rolled into cohorts that re­ceive es­ca­lat­ing single doses of I-131-CLR1404 com­bined with a set dose of dexa­meth­a­sone. The first cohort of subjects will re­ceive a 12.5 mCi/m2 dose of I-131-CLR1404. A min­i­mum of three subjects will be en­rolled at each dose level. Dose escalation and level ex­pan­sion will be guided by safety and will be per­formed after all subjects in a cohort have been followed for 12 weeks. Fol­low­ing identi­fi­ca­tion of the highest tol­er­ated dose, addi­tional I-131-CLR1404-naïve subjects will be en­rolled and treated with the identified dose of I-131-CLR1404 without concurrent oral dexa­meth­a­sone.

"I-131-CLR1404 has been generally well tol­er­ated in patients and we be­lieve that its selectivity and potency provide a solid rationale for its use in mul­ti­ple myeloma," said Dr. Simon Pedder, pres­i­dent and chief exec­u­tive officer of Cellectar Biosciences. "Based on results from our Phase I trials and the radiosensitivity of mul­tiple myeloma, we be­lieve 12.5 mCi/m2 is a meaningful start­ing dose of I-131-CLR1404 and evi­dence of clin­i­cal ac­­tiv­ity will be assessable rel­a­tively early in the dose escalation process."

About Multiple Myeloma

Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone mar­row. According to the National Can­cer In­sti­tute, mul­ti­ple myeloma is the sec­ond most common blood cancer in the United States and con­sti­tutes approx­i­mately 1 per­cent of all cancers. The National Can­cer In­sti­tute esti­mates that 24,500 Americans were diag­nosed with mul­ti­ple myeloma in 2014 and ap­prox­i­mately 11,000 myeloma patients die each year.

About I-131-CLR1404

I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted radiopharmaceutical com­prised of a pro­pri­e­tary op­ti­mized 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. I-131-CLR1404 is engi­neered to com­bine an intracellular radi­a­tion mech­a­nism of cancer cell kill­ing with targeted de­livery to a wide range of malignant tumor types. Pre­clin­i­cal models have also dem­onstrated sel­ective uptake and retention in cancer stem cells, sug­gesting the poten­tial for longer lasting cancer remission. I-131-CLR1404 has been granted orphan drug desig­na­tion from the U.S. Food and Drug Admin­istra­tion for the treat­ment of mul­ti­ple myeloma.

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, 2014. 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.