BioCentury
ARTICLE | Clinical News

Gamida reports StemEx data for hematologic malignancies

February 5, 2013 1:58 AM UTC

Gamida Cell Ltd. (Jerusalem, Israel) said StemEx met the primary endpoint of improving the mortality rate at 100 days post-transplantation vs. a historical control group in the Phase II/III ExCell trial to treat hematologic malignancies (15.8% vs. 24.5%, p=0.034). The open-label, international trial enrolled 101 patients with hematologic malignancies following myleoablative therapy who did not have a matched, family-related bone marrow donor. The historical control comprised a similar group of patients who were transplanted with double cord blood from 2006-2010.

Gamida Cell said a complete analysis of the data will be available this quarter, with regulatory submissions for StemEx in the U.S. and Europe slated for 2014. The product comprises ex vivo expanded cord blood stem/progenitor cells in combination with non-expanded cells from the same cord blood unit. ...