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Monday, December 12, 2016 12:32:45 PM
TEL AVIV, Israel, Dec. 12, 2016 (GLOBE NEWSWIRE) -- Elbit Imaging Ltd. (EMITF) (EMITF) ("Elbit" or the "Company") announced today that it was informed by Gamida Cell Ltd. ("Gamida Cell"), an indirect associate of the Company, that Gamida Cell has been cleared by the U.S. Food and Drug Administration to begin enrolling for the Phase 3, international, multicenter trial of Gamida Cell's NiCord® for patients with high risk hematological malignancies (blood cancers) (the "Trial"). In addition, Gamida Cell has informed the Company that clearance to begin enrolling for the NiCord study has also been received for an additional European territory.
The Trial is planned to be a randomized-controlled study comparing transplantation of NiCord to that of un-manipulated umbilical cord blood. A total of 120 patients will be enrolled at transplantation centers throughout the US and Europe. Gamida Cell estimates that patient recruitment will take approximately two years to complete. The primary endpoint of the study is to examine the time from transplant to engraftment of neutrophils.
As of today, the development of NiCord remains at the clinical stage of development.
Gamida Cell develops cellular and immune therapies for the treatment of cancer and orphan genetic diseases. Gamida Cell's lead pipeline products are in clinical development as alternative therapeutic treatments for many patients indicated for bone marrow transplant, but who cannot find the necessary fully matched donor. These include NiCord for blood cancers and CordIn for sickle cell disease and thalassemia.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.6% on a fully diluted basis) which, in turn, holds approximately 25% of the share capital in Gamida (22.5% on a fully diluted basis).
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