Health Canada has approved the initiation of a Phase I/II clinical trial for ExCellThera’s lead product, ECT-100, for the expansion of hematopoietic stem cells (HSCs). The trial will begin early 2016 and will enroll up to 25 patients who require stem cell transplantation for the treatment of acute myeloid leukemia (AML) and other malignant blood disorders with no suitable donor. The trial will take place at multiple Canadian transplant centres but the lead site will be Maisonneuve-Rosemont Hospital in Montreal.
“Health Canada’s approval of ExCellThera’s first clinical trial is an important milestone for the company,” commented Steven J. Klein, CEO of ExCellThera. “ECT-100 will represent a new therapeutic option for patients requiring stem cell transplantation and who lack a traditional donor. We look forward to obtaining initial clinical data for ECT-100 in 2016.”