Cellectar Biosciences Announces INC Research As The CRO For The Phase II Trial Of CLR 131 In Hematologic Malignancies; $2M NCI Grant Covers Half Of Study Cost, With Potential Option To Pursue Additional $3M For Pivotal Trial
MADISON, Wis., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, today announced it has selected INC Research (Nasdaq:INCR), a leading global Phase I to IV contract research organization, to oversee its NCI-supported Phase II clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies. The company anticipates that its $2M NCI grant will cover approximately 50 percent of the study's cost, and the terms of the grant allow Cellectar to pursue an additional $3M for a pivotal Phase III trial of the company's lead radiotherapeutic compound. Cellectar plans to leverage the results of its 80-patient, Phase II 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 (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL), 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 II 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."