Gamida Cell has completed enrolment in a Phase I/II study of second pipeline product NiCord for haematological malignancies (HM or blood cancer).
NiCord, which is based on Gamida Cell’s proprietary NAM technology, is an expanded cell graft derived from umbilical cord blood enriched with stem cells.
The Phase I/II study, which enrolled 11 patients, will evaluate NiCord as an alternative investigational treatment for HM and is expected to provide the results within six months.
Gamida Cell research and development vice president and chief scientific officer Dr Tony Peled said that pre-clinical data demonstrated the uniqueness of NAM technology in decreasing the aging process and preserving the characteristics and functions of ex vivo expanded stem cells.
"Of significance, the Phase I/II clinical trial data have already shown that many of the patients in the study engrafted with the expanded cells of NiCord rather than with the second un-manipulated unit," Dr Peled said.
"This is the first time, in a situation where two units are transplanted, that the cultured stem cells demonstrated prompt and durable long-term engraftment (over one year) in the clinic. We look forward to sharing the complete results of this study in the coming months."
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The company is also enrolling for a Phase I/II study of NiCord as an experimental treatment for sickle cell, a genetic blood disease.
NiCord is in development as an experimental treatment for indications that could be cured with a bone marrow transplantation such as blood cancer, sickle cell disease, thalassemia, autoimmune diseases and metabolic diseases.
Gamida Cell CEO Dr Yael Margolin said; "In the near future we plan to not only release the NiCord Phase I/II data but also the long awaited complete results of the Phase III study of StemEx, also for hematological malignancies, but clearly further ahead in development."
Image: Micrograph of a plasmacytoma, a hematological malignancy. Photo: Nephron.