| TEL AVIV, Israel, Aug. 12, 2019 /PRNewswire/ — Following the one month data of the 9th patient, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from Cellect Biotechnology Ltd.’s (Nasdaq: APOP) ongoing Phase 1/2 clinical study of ApoGraft™, and announced that the DSMB unanimously recommended dose escalation and the continuation of enrollment for the fourth and final dose cohort in the study.
At one-month post transplantation, the patient has shown complete engraftment and has not demonstrated any procedure-related adverse effects. The Company currently expects to complete the patient recruitment by the end of 2019 and release data during the first half of 2020. 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. In the U.S., the Company moved closer to the U.S. clinical trial as Washington University’s Scientific Review Committee (SRC) approved the Company’s study, with no comments. This, along with the other milestones that have been achieved by the Company over the past few months demonstrate solid progress and the Company is looking forward to working with its clinical partner and sharing further progress in the coming months. “We are increasingly pleased with our global clinical progress,” commented Dr. Shai Yarkoni, Chief Executive Officer. “In Israel, the DSMB’s recommendation to proceed to the final cohort of our ApoGraft study without modification furthers us towards meeting our goal of enrolling the final three patients by the end of this year, which reaffirms the positive safety data to date. In the U.S., we are getting closer to realizing our plans to initiate our first trial in the U.S. as evidenced by the SRC’s recent approval of our study.” About Cellect Biotechnology Ltd. The Company’s technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company’s current clinical trial is aimed at bone marrow transplantations in cancer treatment. Forward Looking Statements Contact Cellect Biotechnology Ltd. Or EVC Group LLC |
Email
Text