Business
Cellectar Receives Orphan Drug Designation from the European Commission for CLR 131 in Multiple Myeloma
FLORHAM PARK, N.J., Sept. 24, 2019 (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., Sept. 24, 2019 (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 European Commission has awarded CLR 131 orphan designation for the treatment of multiple myeloma.\n Orphan designation is given to medicinal products that represent a significant benefit over existing treatments; are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; and where prevalence of the condition in the EU is less than 5 in 10,000 persons. “We are very pleased to receive Orphan Drug Designation from the European Commission as it is another important acknowledgement of the potential benefits of CLR 131 in multiple myeloma,” said James Caruso, president and CEO of Cellectar Biosciences. “This designation complements our U.S. orphan drug designation and U.S. fast track designation already granted by the FDA. CLR 131 has shown encouraging results to date in the treatment of late line relapsed/refractory multiple myeloma as demonstrated in our recent presentation at the International Myeloma Workshop. We look forward to sharing additional data from our clinical trials later this year.” The European Medicines Agency (EMA) plays a central role in facilitating the development and authorization of medicines for rare diseases. Orphan designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Detailed information on orphan designation can be found here. About CLR 131CLR 131 is a small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug ConjugateTM (PDC) designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. CLR 131 is the company’s lead therapeutic PDC product candidate and is currently being evaluated in both Phase 2 and Phase 1 clinical studies. The FDA granted orphan drug designation for CLR 131 for the treatment of multiple myeloma as well as orphan drug and rare pediatric disease designations for CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. In add...