Phase 3 study of NiCord commenced last month in blood cancer patients
Jerusalem, Israel, March 23, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT).
“We are very encouraged that the EMA has widened NiCord’s orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications,” said Gamida Cell president and CEO Dr. Yael Margolin. “This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase 3 study and prepare for commercialization.” [Read more…]