Gamida Cell Ltd. today reported success in the Phase III clinical trial of its StemEx treatment for leukemia and lymphoma. Preliminary analysis of the results indicates that the trial met its primary endpoint the - mortality rate of patients 100 days after the implants of the stem cells. The company expects to obtain the secondary endpoints in a few weeks.
The study included 101 patients at 25 medical bone marrow transplant centers in the US, Europe, and Israel. The control group included 300 patients with characteristics similar to those of the participants in the study. The patients in the control group received two doses of double cord umbilical blood transplantation in 2006-10. The mortality rate among the patients who received StemEx was 15.8%, compared with a mortality rate of 24.5% among the patients in the control group.
On the basis of the results, Gamida Cell will apply to register StemEx, an allogeneic stem cell product, in the US and Europe.
In a separate development, Gamida Cell said that it was continuing the Phase I/II clinical trial of its NiCord product for the treatment of hereditary anemia and malignant blood diseases.
Elbit Medical Technologies Ltd. (TASE:EMTC) owns 30.8% of Gamida Cell and Clal Biotechnology Industries Ltd. (TASE: CBI) owns 22%. Other shareholders include Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), Amgen Inc. (Nasdaq: AMGN), Israel Healthcare Ventures Ltd., Denali Ventures and Auriga Ventures. Teva is relinquishing development of leukemia treatment StemEx as part of its new strategy, announced in December.
Published by Globes [online], Israel business news - www.globes-online.com - on February 4, 2013
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