Athersys, Inc. announced that the US Food and Drug Administration (FDA) has authorized commencement of a phase II clinical trial evaluating the safety and efficacy of administration of MultiStem, Athersys' 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 Athersys and Pfizer that the companies formed in December 2009 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 eight 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 centres in North America and Europe.

This is the fourth clinical study of MultiStem authorized by the FDA and the first in the autoimmune disease area. "This announcement demonstrates exciting progress, achieved within a year of launching the collaboration, and reflects the tremendous effort on the part of the teams at both organizations that are working together to advance this programme in a focused and efficient manner," said Gil Van Bokkelen, Ph.D., chairman and chief executive officer of Athersys.

"This is a very exciting day as we celebrate this milestone achieved with our collaborator Athersys," said Ruth McKernan, senior vice president and Pfizer Regenerative Medicine Chief Scientific Officer.  "The speed at which this has occurred is an indicator of the depth of the collaboration between the Pfizer Regenerative Medicine and Athersys teams.  We look forward to continuing to work together on this programme."

MultiStem is a patented and proprietary product consisting of a clinical grade preparation of non-embryonic stem cells obtained from bone marrow that have the potential to produce a range of factors and form multiple cell types. MultiStem appears to work through several mechanisms, but a primary mechanism appears to be the production of therapeutic proteins and other molecules produced in response to inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on its apparent ability to be used without tissue matching or immunosuppression and its capacity for large scale production.

Athersys is a clinical stage biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life.