Date: 2015-08-10
Type of information: Submission of a clinical trial application
phase: 3
Announcement: submission of a clinical trial application
Company: Gamida Cells (Israel)
Product: NiCord®
Action
mechanism: cell therapy. NiCord® is derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell’s proprietary NAM technology. NiCord® is in development as an investigational therapeutic treatment for blood cancers such as leukemia and lymphoma and for non-malignant hematological diseases. Clinical sites in the US, Spain, Italy, Israel and the Netherlands will collectively enroll 20 patients, with hematologic malignancies following myeloablative therapy, in the Phase I/II study of NiCord®, in a single cord configuration.
Disease: hematological cancers
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 10, 2015, Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced that the company has reached agreements with the FDA and EMA regarding the Phase III study design outline of NiCord®. The company is moving forward now with plans to commence an international, multi-center, Phase III study of NiCord in 2016. This Phase III study will be a randomized controlled study of around 120 patients. It will compare the outcomes of patients transplanted with NiCord® to those of patients transplanted with un-manipulated umbilical cord blood. Phase I/II data of 15 patients are expected in Q4/2015. NiCord® is in development as an experimental treatment for various types of blood cancers including AML, ALL, MDS and CML.
