Stem Cell Therapeutics Announces Completion of Enrollment in Key Modified REGENESIS Phase IIb Stroke Trial
News Apr 01, 2010
Stem Cell Therapeutics Corp. has announced that it closed patient enrollment of the modified Phase IIb stroke trial on March 31st, 2010 and will analyze the data as they become available. Using a modified statistical approach the Company will analyze its trial data using the 96 patients that were enrolled.
Dr. Alan Moore, President and CEO, commented as follows:
"The modified REGENESIS-LED Phase IIb stroke trial enrolled 96 patients in six months which is a tremendous achievement. Despite our best recruitment efforts, however, we have not recruited any additional North America patients. The last patient in the trial was recruited at the end of January 2010. Using an alternate method of data analysis, with a proven track record (used in one of t-PA's pivotal phase III studies) will allow us to achieve our endpoint with fewer patients while staying on track with our previously reported time-line. We look forward to receiving the results of this clinical trial for the treatment of stroke patients with NTx(R)-265."
With the modified Phase IIb stroke trial closed, SCT anticipates to complete patient 90 day endpoint assessments by the end of April 2010 with data analysis to follow soon after.