Eligible patients had moderate-to-severe active UC with a Mayo score of 6 to 12 points and endoscopic score of at least 2 (as measured by modified Baron score
) despite prior treatment with corticosteroids, immunosuppressants, or anti-TNF agents.
In this chronic, advanced UC patient population, a single IV administration of MultiStem did not show a statistically significant improvement compared to placebo in the primary efficacy endpoints--change in endoscopic score from baseline as measured by modified Baron score
at 8 weeks and change in Mayo rectal bleeding subscore from baseline at 4 and 8 weeks.
Endoscopic score was evaluated using simplified endoscopic score in Crohn's disease (SES-CD) or Baron score
for patients with CD or UC, respectively.
Along the way, McCudden had some fascinating experiences: he flew for a time with fellow British ace, Arthur Rhys-David (25 kills); witnessed the demise of German ace Werner Voss; and saw the Red Baron score
one of his 80 confirmed kills.
The primary endpoints for the study include incidence and severity of adverse events over 16 weeks, change in endoscopic score (as measured by modified Baron score
) at week eight, and changes in the Mayo rectal bleeding sub-score at weeks four and eight.