Athersys: Pfizer Completes Patient Enrollment In Phase II MultiStem Cell Therapy

(RTTNews) - Athersys Inc. (ATHX) Thursday said Pfizer Inc.(PFE) has completed patient enrollment of a Phase II study that involves the administration of Athersys' MultiStem cell therapy to ulcerative colitis patients, pursuant to a 2009 collaboration agreement between the companies. The initial results from the study are expected in the 2014 second-quarter in two parts. The first results, which would describe the primary and certain secondary and exploratory endpoints, is anticipated in April or May. The second results will cover additional data for subjects, which is expected later in the second quarter.

The trial is being conducted by Pfizer in the United States, Canada and Europe. The primary endpoints for the study include incidence and severity of adverse events over 16 weeks, change in endoscopic 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.

"Based upon MultiStem's preclinical safety and efficacy profile and novel mechanisms of action, we believe that MultiStem could provide meaningful benefit to these patients. The results from this study should provide significant insight into the potential for MultiStem therapy for the treatment of inflammatory bowel disease." said John Harrington, Chief Scientific Officer at Athersys.