This will be the first clinical trial in the U.S. using Tel Aviv, Israel-based Cellect’s ApoGraft, which is designed to prevent acute graft-versus-host disease following bone marrow transplantation. The company previously reported positive safety and tolerability data from an ongoing trial that is being performed outside the U.S., and expects to report additional interim results during the first half of 2019.
Preliminary data from that study indicated that half of the planned patients show complete engraftment and no procedure-related adverse events. In the first three patients who completed the full study, safety and tolerability were positive, with no related adverse events (the primary endpoint) and engraftment before 28 days post-transplant, the company said.
The open-label U.S. clinical trial is designed to evaluate the safety and tolerability of the ApoGraft process in blood cancer patients who are undergoing an allogeneic hematopoietic stem cell transplantation (HSCT). The primary endpoint of the study is overall incidence, frequency, and severity of adverse events potentially related to ApoGraft at 180 days from transplantation. The company expects to complete the enrollment of 12 patients in the second quarter of 2019.
The U.S. collaboration is led by John DiPersio, M.D., director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine (St. Louis, Missouri) and president of the American Society for Blood and Marrow Transplantation, and bone marrow transplantation expert Mark Schroeder, M.D. from the medical school’s Division of Oncology.
“This is a very significant development for Cellect and demonstrates that our leading technology is garnering attention from the most influential clinical institutions in the U.S.,” said Cellect CEO Shai Yarkoni, M.D., in a prepared statement. “We believe Cellect’s ApoGraft stem cell selection technology has the potential to improve the lives of millions of patients and be a game changer in bone marrow transplantation — the largest multi-billion-dollar segment of cell therapy in the U.S.”