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EU grants BiolineRX treatment orphan drug status

Israeli clinical-stage biopharmaceutical company BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) today announced that the European Commission (EC) has granted Orphan Drug Designation to its lead oncology candidate, Motixafortide (BL-8040), for the treatment of pancreatic cancer, based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). Last year, Motixafortide received Orphan Drug Designation for the treatment of Pancreatic Cancer from the US Food and Drug Administration (FDA).

BiolineRX CEO Philip Serlin said, “The Orphan Drug status we received for Motixafortide, from both the US and European regulatory bodies, is of significant strategic importance for the development of our lead product for the treatment of pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments. We recently reported very encouraging initial data from the triple combination arm of our ongoing Phase IIa COMBAT/KEYNOTE-202 study in second line metastatic pancreatic cancer patients, which served as the basis for this ODD, and we believe that this designation will maximize the potential to make this new treatment available for patients in the fastest way possible.”

Motixafortide is currently being evaluated in a Phase IIa study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with Merck Co., Inc.

The EMA grants orphan medicinal product designation to investigational drugs intended to treat, prevent or diagnose a life-threatening or chronically debilitating disease affecting fewer than five in 10,000 people in the EU and for which no satisfactory treatment is available.

Published by Globes, Israel business news – – on January 14, 2020

© Copyright of Globes Publisher Itonut (1983) Ltd. 2020

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