MADISON, Wis., Dec. 06, 2017 — Cellectar Biosciences (Nasdaq:CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that the company will increase the targeted patient enrollment in the relapsed/refractory (R/R) multiple myeloma (MM) cohort of its currently enrolling Phase 2 clinical trial of CLR 131. Data from the MM cohort of the study demonstrated that the treatment exceeded pre-specified criteria for clinically meaningful benefit. As a result, the cohort will be expanded up to as many as 40 patients. “The initial results from the multiple myeloma arm of this Phase 2 study underscore the potential for CLR 131 to benefit these heavily pre-treated and relapsed patients. We continue to see clinical benefit with CLR 131 in both our Phase 1 and Phase 2 clinical studies and look forward to reporting additional data from the both of these clinical studies next year,” stated James Caruso, president and chief executive officer of Cellectar Biosciences. “Furthermore, we are pleased to have achieved this key clinical milestone within our projected timelines,” added Mr. Caruso.About the Phase 2 Study of CLR 131
The Phase 2 study is being conducted in approximately 10 leading cancer centers in the United States for patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being studied include (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). The study's primary endpoint is clinical benefit response (CBR), with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later.In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. Cellectar will receive approximately $2 million in a non-dilutive grant from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.About CLR 131
CLR 131 is an investigational compound under development for a range of orphan designated cancers. It is currently being evaluated as a single-dose treatment in a Phase I clinical trial in patients with R/R MM as well as in a Phase II clinical trial for R/R MM and select R/R lymphomas with either a one- or two-dose treatment. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating solid and hematological tumors and may provide patients with therapeutic benefits, including overall survival, an improvement in progression-free survival, surrogate efficacy marker response rate, and overall quality of life. CLR 131 utilizes the company's patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of MM.
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