Gamida Cell announced today the successful results of the Phase I/II study of its second pipeline product NiCord, umbilical cord derived stem cells expanded using the company's proprietary NAM technology. Study data was announced today during an oral presentation titled Nicord® Expanded Hematopoietic Progenitor Cells (HPC) Are Capable of Outcompeting the Unmanipulated (UM) Cord Blood Unit and of Prolonged Myeloid and Lymphoid Engraftment Following Myeloablative Dual Umbilical Cord Blood (UCB) Transplantation. The presentation was delivered at the prestigious 2013 BMT Tandem Meetings in Salt Lake City by Dr. Mitchell E. Horwitz, associate professor of medicine at Duke Medicine and a principal investigator of the NiCord study for hematological malignancies (HM).
Eleven patients, ages 21-61, with high-risk hematological malignancies received NiCord and an un-manipulated graft of umbilical cord blood. Eight patients engrafted with NiCord. The median time to neutrophil engraftment was 10.5 (7-18) days for those engrafting with NiCord. Two patients engrafted with the un-manipulated UCB and one patient experienced primary graft failure. There were no cases of Grade III/IV acute GvHD. No safety concerns surrounding the use of NiCord were raised. With a median follow-up of 8 months, the progression-free and overall survival are both 90%.
Dr. Horwitz said, "The results from this early study suggest that NiCord expanded hematopoietic progenitor cells (HPCs) reduce the time to hematopoietic recovery and are capable of long term (>22 months) neutrophil and T-cell engraftment. Co-transplantation of NiCord and an un-manipulated cord blood unit is feasible and safe. Further studies are planned to confirm that the NiCord product can be transplanted as a single expanded unit, without co-infusion of un-manipulated cells. This would mean that only one cord blood unit would be used for transplantation, rather than two units, as are used today in most adult umbilical cord blood transplantations."