Gamida Cell Ltd. today announced successful results in its Phase I/II study of NiCord, an umbilical cord derived stem cells product, for the treatment of blood cancer. There were no serious cases of acute graft-versus-host disease, and no safety concerns were raised. With a median follow-up of 8 months, the progression-free and overall survival rates are both 90%.
In the study of eleven patients, ages 21-61, with high-risk hematological malignancies, eight patients received NiCord, two patients received an un-manipulated umbilical blood cell transplant, and one patient experienced primary graft failure.
Gamida Cell VP clinical development and regulatory affairs Dr. David Snyder said, “We view NiCord as a paradigm shift in cord blood transplantation as this is the first technology that allows for durable engraftment of ex vivo expanded hematopoietic stem cells. It is also significant that NiCord engrafted unusually fast with apparent robust immune reconstitution."
Dr. Snyder added, "Gamida Cell opted to begin clinical research of NiCord in hematological malignancies as cancer serves as a good bench mark. The early results of the hematological malignancies study further supports the company’s ambitions to continue its initiative to develop NiCord for other indications including sickle cell disease, thalassemia, severe autoimmune diseases and genetic metabolic diseases. In fact, a phase I/II study is currently enrolling pediatric patients with sickle cell disease at Duke Medicine and at the Steven and Alexandra Cohen Children's Medical Center of New York.”
Earlier this month, Gamida Cell reported success in the Phase III clinical trial of its stem cell treatment, StemEx, for leukemia and lymphoma.
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 14, 2013
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