Gamida Cell Ltd. has announced a new development concerning NiCord, its umbilical cord blood-based treatment for blood cancers. The company reports that the first patient has been successfully transplanted in the company’s second Phase I/II study of NiCord as an alternative, experimental treatment for blood cancers. The transplant took place at Duke University Medical Center, as part of a study researching the outcome of a whole umbilical cord blood unit (UCBU) expanded in culture and transplanted in myeloablated patients without the support of un-manipulated stem cells derived from a second UCBU. Gamida Cell claims that the approach using NiCord as a single stem cell graft has the potential to broaden accessibility, reduce toxicity and improve the clinical and economic outcomes of cord blood transplantation. "We are witnessing a paradigm shift in transplantation. The first patient was successfully transplanted with a stem cell graft entirely expanded in ex vivo cultures and without the support of a second unit of un-manipulated stem cells," said Gamida Cell CEO Dr. Yael Margolin.
The transplant was part of a second Phase I/II clinical trial.
The study comes a few months after the US Food and Drug Administration (FDA) notified Gamida Cell that more studies were needed on its lead product, StemEx. Both NiCord and StemEx are designed to improve umbilical cord blood stem cell grafts for the treatment of leukemia and lymphoma.
NiCord is also being developed for other indications, including sickle cell disease, thalassemia, severe autoimmune diseases and genetic metabolic diseases. A phase I/II study is underway on pediatric patients with sickle cell disease at Duke Medicine and at the Steven and Alexandra Cohen Children's Medical Center of New York.
Gamida Cell is controlled by Clal Biotechnology Industries Ltd. (TASE: CBI) and Elbit Medical Technologies Ltd. (TASE:EMTC).
Published by Globes [online], Israel business news - www.globes-online.com - on September 9, 2013
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