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Cellectar Receives Orphan Drug Designation for CLR 131 in Lymphoplasmacytic Lymphoma (LPL)
FLORHAM PARK, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"FLORHAM PARK, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131 in Lymphoplasmacytic Lymphoma (LPL). CLR 131 is the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate currently in a Phase 2 clinical study in relapsed or refractory select B-cell lymphomas, including Lymphoplasmacytic Lymphoma (LPL).\n “The orphan designation from the FDA for LPL represents the sixth for CLR 131 and underscores Cellectar’s commitment to develop therapies for rare cancers with limited treatment options and high unmet need,” stated James Caruso, president and CEO of Cellectar Biosciences. “CLR 131 has demonstrated encouraging results in our ongoing Phase 2 CLOVER-1 trial in select B-cell lymphomas, which includes LPL patients. We look forward to sharing Phase 2 LPL clinical data in the near term.” The FDA grants ODD to therapies targeting conditions that affect fewer than 200,000 people in the U.S. The designation provides seven years of market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. CLR 131 has previously been granted Orphan Drug designation for the treatment of multiple myeloma by both the U.S. and the European Commission and Rare Pediatric Disease and Orphan Drug designations for the treatments of neuroblastoma, rhabdomyosarcoma, osteosarcoma, Ewing’s sarcoma. About Lymphoplasmacytic Lymphoma (LPL)LPL is a rare type of non-Hodgkin’s lymphoma that develops slowly and affects mostly older adults. The average age at diagnosis is 60. Lymphomas are cancers of the lymph system, a part of the immune system that helps to fight off infections. In lymphoma, white blood cells, either B lymphocytes or T lymphocytes, grow out of control because of a mutation. In LPL, abnormal B lymphocytes reproduce in the bone marrow and displace healthy blood cells, compromising the body’s immune system and potentially resulting in anemia, neutropenia, or thrombocytopenia. About the Phase 2 CLOVER-1 TrialCLOVER...