Athersys Announces Positive Interim Results From Ongoing Phase I Study of MultiStem(R)

Athersys ATHX today announced positive interim results from an ongoing Phase I clinical trial of MultiStem^®, its cell therapy product, administered to individuals undergoing allogeneic hematopoietic stem cell transplants for the treatment of leukemia and related conditions. The study results for the single infusion arm of this Phase I clinical trial demonstrate that MultiStem was well tolerated at all dose levels and also suggest that the product may reduce the incidence of severe Graft-versus-Host Disease a potentially life-threatening complication of such transplants, as compared to historical clinical experience. The repeated dose administration arm of the clinical trial is ongoing and enrollment is expected to be completed in 2011. In 2010, Athersys was granted orphan drug designation by the U. S. Food and Drug Administration for MultiStem for the prevention of GvHD. Interim data highlights from the single dose administration arm of the study included: * No observations of infusional or product-related toxicities over 30 days following treatment, and no product-related serious adverse events (SAEs) over 100 days following treatment; * No primary or secondary HSCT-graft failure through day 100; * Overall, a low cumulative incidence of acute GvHD over the 100-day observation period for all subjects enrolled (28% grade II-IV, 6% grade III-IV), which compares favorably with expectations for this patient population based on historical experience; * In the high dose group, no cases of grade III-IV GvHD, and only one case of grade II GvHD, which was subsequently resolved with treatment; and * Other clinical parameters, such as infection and survival, were in line with or better than expectations for this patient population based on historical data.