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news.Gamida Cell announced that it has met with a primary endpoint of overall survival in a Phase II/III study of StemEx, designed for the treating patients with hematological malignancies such as leukemia and lymphoma.
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StemEx, which is a graft of an expanded population of stem/progenitor cells derived from part of a single unit of umbilical cord blood, is transplanted by IV administration along with the remaining, non-manipulated cells from the same unit, claims the company.
The comparative study, which had enrolled patients with hematologic malignancies following myleoablative therapy, included the historical control cohort which comprised a similar group of patients each transplanted with double cord blood during the years 2006-2010.
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 it is currently looking for a strategic partner for the global commercialization of StemEx.