Cellect Biotechnology announces 'positive' outcome from DSMB on ApoGraft
Following the one month data of the 9th patient, the Data and Safety Monitoring Board reviewed the safety data from Cellect Biotechnology Ltd.'s 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 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.