Cellect Begins Collaboration with Washington University in Preparation for First U.S. Clinical Trial Using Cellect's ApoGraft™
Wednesday, February 06, 2019
Cellect Biotechnology Ltd., a developer of a novel stem cell production technology, today announced a collaboration with Washington University, a leading academic institution based in St. Louis, MO, aimed at determining the safety and tolerability in a U.S. Phase I/II study using ApoGraft™ for bone marrow transplantations. The collaboration is led by Dr. John DiPersio, Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine and President of the American Society for Blood and Marrow Transplantation, and Dr. Mark Schroeder, an expert in bone marrow transplantation in the Division of Oncology at Washington University School of Medicine.
This will be the first clinical trial in the U.S. using the Company's ApoGraft stem cell selection technology, which is designed to prevent acute graft-versus-host disease following bone marrow transplantation. Previously, the Company has 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. This open label clinical trial of twelve patients, expected to complete recruitment during the second quarter of 2019, is designed to evaluate the safety and tolerability of the ApoGraft™ process in patients with hematological malignancies 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. Preliminary data reported in October by the Company has indicated:
- One-month assessment of half of the planned patients in the ApoGraft™ study show complete engraftment and no procedure-related adverse events.
- In the first three patients completing the full study, safety and tolerability were positive, with no related adverse events (the primary endpoint) and engraftment before 28 days post-transplant.
"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 Dr. Shai Yarkoni. "We have already reported positive preliminary results for a trial being conducted outside of the U.S., and I believe the collaborative efforts with a leading U.S.-based institution may advance and heighten awareness of our technology. 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."
Washington University School of Medicine in St. Louis is among the leading medical centers in the U.S. This is Cellect's first collaboration with a US site for clinical development following the establishment of the clinical advisory committee consisting of Prof Negrin of Stanford, Dr. Cutler of Harvard medical school and Professor Rowe of Northwestern University. Cellect's ApoGraft™ is currently being evaluated outside of the U.S. in a Phase I/II clinical trial for prevention of acute GvHD in patients with hematological malignancies who are receiving allogeneic hematopoietic stem cell transplantation. Additional interim data is expected in H12019 and topline results by the end of the year.
