Gamida Cell has announced that its Phase II/III study of StemEx for the treatment of hematological malignancies such as leukemia and lymphoma met its primary endpoint of overall survival.
StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood, and is transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.
The study has enroled patients with hematologic malignancies following myleoablative therapy and who could not find a family related matched bone marrow donor.
The comparative study included the historical control cohort, which comprises a similar group of patients each transplanted with double cord blood during the years 2006-2010, according to the company.
The results demonstrated mortality of 15.8% in the StemEx group and 24.5% in the control group (p=0.034).
Gamida Cell president and CEO Dr Yael Margolin said, "We remain focused on completing the development of StemEx as an alternative stem/progenitor cell source for transplantation in patients who cannot find a family related matched bone marrow donor."
The company said StemEx utilises a technology for expanding the therapeutic capacity of cord blood stem/progenitor cells for transplantation in adolescents and adults.
StemEx has been developed by the Gamida Cell-TEVA joint venture, which owns all global rights for the commercialisation of StemEx.
Gamida Cell said it is currently looking for a strategic partner for the global commercialisation of StemEx.