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Cellect Biotechnology Announces Positive Data Demonstrating Robust Engraftment Using ApoGraft was Featured in Bone Marrow Transplantation; Primary Data Points Were Submitted to the FDA During Investigational New Drug Approval Process

Cellect Biotechnology Ltd.

Benzinga · 05/11/2020 10:23

Cellect Biotechnology Ltd. (NASDAQ: APOP) today announced the publication of an article in Bone Marrow Transplantation, a peer-reviewed medical journal )member of the Nature publishing house) covering transplantation of bone marrow in humans and published monthly by the prestigious Nature Research, entitled 'Ex-vivo FAS-ligand to Improve Allograft Safety'. The article is co-authored by researchers at Cellect and its academic partners.

The paper highlights the pre-clinical research and demonstrates that engraftment is robust following transplantation of treated graft, and the graft retains its immune reconstitution and anti-leukemic effects. The Company has initiated a Phase 1/2 study in adults undergoing stem cell transplant for the treatment of hematological malignancies. The primary endpoint of the study is to evaluate the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft™ at 180-days post-transplant.All patients transplanted through present time using the ApoGraft™ process were engrafted and time to engraftment was similar to the standard of care. To date, there have not been any safety and tolerability concerns during the study and patient enrollment is continuing. Both, the principal investigator (PI) and independent data safety monitoring board (DSMB) agree that no serious adverse events (SAEs) reported during the course of the study were related to the ApoGraft™ process.

The data from the pre-clinical research, and published in this paper, was included in the Company's Investigational New Drug (IND) application, which was approved by the U.S. Food and Drug Administration in late 2019.The Company has received all the necessary approvals to initiate the trial with its academic partner, Washington University, and plans to begin patient recruitment once the COVID-19 pandemic is mitigated and clinics can resume normal practices.