On November 28, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported it has selected Hamilton, Ontario-based Centre for Probe Development and Commercialization (CPDC), a well-respected GMP manufacturing organization specializing in radiopharmaceuticals, as a supplier of the company’s lead phospholipid drug conjugate (PDC), CLR 131 (Filing, 8-K, Cellectar Biosciences, NOV 28, 2016, View Source [SID1234516808]).
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The company believes that CPDC will provide a cost-effective and long-term manufacturing solution. The partnership establishes manufacturing capacity at a level sufficient for both a pivotal trial and future large-scale commercial production. CPDC’s development of further production capability for CLR 131 will significantly enhance the company’s ability to support the anticipated clinical trial activity as it progresses through 2017 while also preparing for a pivotal study and, ultimately, commercialization.
"This partnership with CPDC signals an important milestone in the development of CLR 131; it reflects our confidence in the potential clinical utility of our lead compound and establishes an additional supply source as well as pivotal trial and commercial scale production," said Jim Caruso, president and CEO of Cellectar Biosciences. "As we prepare to initiate our NCI-supported Phase II trial of CLR 131 in multiple myeloma and other hematologic malignancies, it is imperative that we continue to identify optimal pathways to accelerate and further support its development."
About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) 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 multiple myeloma.