Cellect Biotechnology Ltd. Initiates U.S. Clinical Trial of ApoGraft
October 22, 2020 at 08:04 am EDT
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Cellect Biotechnology Ltd. announced that it has initiated its clinical trial in the U.S. to determine the safety and tolerability of the ApoGraft technology for bone marrow transplantations (BMT). The trial will enroll 18 patients and the primary end point of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft at 180 and 360 days from transplantation. This is the second clinical trial of ApoGraft. The first trial in Israel has enrolled eleven patients, and the dose level of the final cohort is identical to the dose level used in the U.S. trial. The Company has previously disclosed interim data showing that the trial unequivocally met the safety and tolerability end point, and the Company expects to publish top line data in early 2021. The trial will be conducted by bone marrow transplantation specialists at Washington University School of Medicine, a leading academic institution based in St. Louis, Missouri and is co-sponsored by the university and Cellect. ApoGraft cell selection technology is designed to prevent graft-versus-host disease (GVHD) following bone marrow transplantation. This is an open label phase 1 clinical trial of eighteen patients and is designed to evaluate the safety and tolerability of the ApoGraft process in patients with hematological malignancies who are undergoing a haploidentical hematopoietic stem cell transplantation (HSCT). The Principal Investigator for the clinical trial is Zhifu Xiang, M.D., of Washington University. He is an Associate Professor in the Division of Oncology's Bone Marrow Transplantation & Leukemia Section in the Department of Medicine. In addition, Mark Schroeder, M.D., and John DiPersio M.D., Ph.D., will act as co-Principal Investigators for the study. Dr. DiPersio is the chief of the Division of Oncology in the Department of Medicine at Washington University. The collaboration is led by Dr. DiPersio, who also is Director of the Center for Gene and Cellular Immunotherapy, Washington University School of Medicine, and a past president of the American Society for Blood and Marrow Transplantation.
Quoin Pharmaceuticals Ltd, former Cellect Biotechnology Ltd, is an Israel-based specialty pharmaceutical company, focused on developing and commercializing therapeutic products that treat rare and orphan diseases. The Companyâs first lead product is QRX003, a once daily, topical lotion comprised of a broad-spectrum serine protease inhibitor, formulated with the proprietary Invisicare technology, to treat Netherton Syndrome. The product going to be developed for other rare dermatological diseases including Peeling Skin Syndrome, SAM Syndrome, and Palmoplantar Keratoderma. Quoin is also developing QRX004 as a potential treatment for Dystrophic Epidermolysis Bullosa, and QRX006 as a potential therapy for an, as of yet, undisclosed rare skin disease.
QUOIN PHARMACEUTICALS, LTD. 
