Gil Roth12.19.13
Pfizer has completed patient enrollment in a Phase II study involving administration of Athersys Inc.'s MultiStem cell therapy to ulcerative colitis patients. The trial, part of a 2009 collaboration agreement between Athersys and Pfizer, is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects with moderate to severe ulcerative colitis. Initial results from the study are expected to be disclosed by 2Q14.
The trial is being conducted by Pfizer at sites in the U.S., Canada and Europe. Subjects enrolled in the study have received either MultiStem treatment or placebo initially, followed by a second round of treatment with MultiStem cells or placebo at eight weeks, resulting in two groups for evaluation through eight weeks and four groups for evaluation through 16 weeks and beyond. 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. Additionally, there are multiple secondary and exploratory endpoints evaluating disease indicators and markers over 16 weeks and through the entire study period.
The trial is being conducted by Pfizer at sites in the U.S., Canada and Europe. Subjects enrolled in the study have received either MultiStem treatment or placebo initially, followed by a second round of treatment with MultiStem cells or placebo at eight weeks, resulting in two groups for evaluation through eight weeks and four groups for evaluation through 16 weeks and beyond. 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. Additionally, there are multiple secondary and exploratory endpoints evaluating disease indicators and markers over 16 weeks and through the entire study period.