Pluristem to Present First Cohort Data from PLX-R18 Hematological Study at ASH Annual Meeting
Pluristem Therapeutics (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the company will present data from the first cohort of its Phase I study of PLX-R18 cells for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology’s (ASH) 60th Annual Meeting to be … Continued
Pluristem Therapeutics (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the company will present data from the first cohort of its Phase I study of PLX-R18 cells for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology’s (ASH) 60th Annual Meeting to be held in San Diego, California, on December 1-4, 2018.
As quoted in the press release:
A Phase I study of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT is ongoing in U.S. and Israel. The trial is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular injections (IM) of PLX-R18 cells in 24 subjects with incomplete hematopoietic recovery persisting for at least 4 months after HCT. The 24 patients in the study will be enrolled into three treatment groups: two administrations of 1 million PLX-R18 cells (n=3), two administrations of 2 million PLX-R18 cells (n=6), two administrations of 4 million PLX-R18 cells (n=15). The primary endpoint will be safety which will be assessed at the end of each cohort by an external safety committee. There will also be exploratory endpoints, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters.
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