Teva-Gamida Cell complete enrollment for blood cancer trial

Gamida Cell's StemEx is a cell therapy for the treatment of leukemia and lymphoma for patients who cannot find a matched bone marrow donor.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Gamida Cell Ltd. have completed enrollment of 100 patients for their Phase III clinical trial of StemEx, a cell therapy for the treatment of blood cancers, such as leukemia and lymphoma. StemEx is intended for adolescents and adults who cannot find a family related, matched bone marrow donor.

Teva and Gamida Cell are conducting the multi-center international clinical trial through their joint venture, which they own in equal shares. StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted together with the remaining, non-manipulated cells from the same unit.

Gamida Cell president and CEO Dr. Yael Margolin said, "The joint venture is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor."

Margolin added, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine."

Nochi Dankner's life sciences investment arm Clal Biotechnology Industries Ltd. (TASE: CBI) owns 20% of Gamida Cell and Mordechai Zisser-controlled Elbit Medical Technologies Ltd. (TASE:EMTC) owns 31.6%.

Published by Globes [online], Israel business news - www.globes-online.com - on February 14, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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