MultiStem: Interim Phase II data
Interim data from 88 patients with moderate to severe UC in the efficacy portion of a double-blind, international Phase II trial showed that a single IV infusion of MultiStem missed the co-primary endpoints of improving endoscopic score from baseline to week 8 as measured by modified Baron score and of improving Mayo rectal bleeding subscore from baseline to weeks 4 and 8 vs. placebo. Additionally, there was no significant difference between the MultiStem and placebo arms on secondary endpoints at weeks 4 and 8, including clinical remission and clinical response. Athersys said MultiStem demonstrated a favorable tolerability and safety profile through week 8.
The trial consisted of 2 parts - a dose-escalation portion in 18 patients and an efficacy portion in 88 patients - and enrolled patients with moderate to severe active UC with a Mayo score of 6-12 points and an endoscopic score of >=2 points despite prior treatment with corticosteroids, immunosuppresants or tumor necrosis factor (TNF) inhibitors. Patients in the efficacy portion received placebo or MultiStem on day 1, plus an additional infusion at week 8. Athersys said 16-week data will be available after additional analysis has been completed. Partner Pfizer conducted the trial. ...