Phase I Clinical Trial of PLX-R18 in Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation (HCT)
A Phase I trial 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 Phase I 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 follow up period will be 12 months. The primary endpoint will be safety, and 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.
Normal bone marrow (BM), irradiated BM and BM treated with PLX-R18:
Pluristem was granted a patent titled “Methods for Treating Radiation or Chemical Injury” for PLX-R18 cell therapy. This important patent, issued by the European Patent Office, expands the company’s IP assets to include a new set of indications related to the bone marrow’s inability to produce blood cells, such as acute radiation syndrome (ARS), autoimmune diseases such as aplastic anemia, genetic disorders, chemotherapy, radiation therapy, and side effects from other treatments.