MADISON, Wis.—Cellectar Biosciences Inc., an oncology-focused, clinical-stage biotechnology company, announced in late 2016 that it had selected INC Research, a leading global Phase 1 to 4 contract research organization, to oversee its National Cancer Institute (NCI)-supported Phase 2 clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies.
The company anticipates that its $2-million NCI grant will cover approximately half of the study’s cost, and the terms of the grant allow Cellectar to pursue an additional $3 million for a pivotal Phase 3 trial of the company’s lead radiotherapeutic compound.
Cellectar plans to leverage the results of its 80-patient, Phase 2 study to optimally design its pivotal trial of CLR 131 in multiple myeloma and other hematologic malignancies. The multi-armed study will include relapse/refractory patients with multiple myeloma, chronic lymphocytic leukemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, mantle cell lymphoma and potentially diffuse large B cell lymphoma who have been treated with standard therapy for their underlying malignancies. The company recently accelerated its guidance and announced plans to initiate the trial during the first quarter of 2017.
“INC Research has outstanding experience in cancer clinical research and a strong reputation within the hematology community. With strong investigator relationships, proven operational expertise and a commitment to high-quality data, they are the ideal partner for this important trial,” said Jim Caruso, president and CEO of Cellectar. “Given the accelerated initiation of our Phase 2 study to the first quarter of 2017 and that we will utilize as many as 15 participating sites, we can confidently plan on providing initial efficacy data in the second half of 2017.”