Phase II Clinical Trial for Inflammatory Bowel Disease, Athersys (ATHX)
The FDA has authorized commencement of a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem(R), ATHX’s allogeneic investigational cell therapy product for the potential treatment of ulcerative colitis.
- This Phase II clinical trial is expected to begin enrolling patients before the end of 2010 and is part of a collaboration between ATHX and Pfizer (PFE) that the companies formed in 12/09 to develop MultiStem for the treatment of inflammatory bowel disease (IBD);
- The Phase II study will be a randomized, double-blind, placebo-controlled, multi-center study to investigate the safety and efficacy of MultiStem in subjects with moderate to severe ulcerative colitis;
- The trial is designed to include approximately 126 patients. Patients participating in the study will receive multiple doses of either MultiStem or placebo, administered over 8 weeks;
- Clinical efficacy endpoints will be examined through week 16 with follow-up of patients for 12 months. The study will be conducted at clinical centers in North America and Europe.
This is the 4th clinical study of MultiStem authorized by the FDA and the first in the autoimmune disease area.
Categories: IBD Phase II Clinical Trial, NASDAQ: ATHX, Stem Cell Technology
