Cellect Biotechnology (NASDAQ:APOP) is up 47% premarket after the Data and Safety Monitoring Board (DSMB) reviewed the safety data from its ongoing Phase 1/2 clinical study of ApoGraft, and 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.
Patient recruitment is expected to be completed by the end of 2019 with data anticipated in H1 2020. The primary endpoint is to evaluate the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft at 180-days post-transplant.
In 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.
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