Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has authorised Athersys to initiate 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.
Subscribe to our email newsletter
The randomised, double-blind, placebo-controlled, multi-center 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 investigate the safety and efficacy of MultiStem in subjects with moderate to severe ulcerative colitis.
The trial is designed to include approximately 126 patients, where the patients will receive multiple doses of either MultiStem or placebo, administered over eight weeks.
Athersys chairman and CEO Gil Van Bokkelen said that 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 organisations that are working together to advance this program in a focused and efficient manner.