SCT Completes the 90 Day Endpoint Period for the Last Patient Enrolled in the Modified REGENESIS Phase IIb Stroke Trial
News Apr 27, 2010
Stem Cell Therapeutics Corp. announces that the 90- day follow up period for the last patient enrolled in the modified REGENESIS- Phase IIb stroke trial has been reached.
The modified REGENESIS- Phase IIb trial, a placebo controlled, double blinded, 3:1 randomized clinical study, enrolled 96 patients with acute ischemic stroke between August 2009 and January 24, 2010. This point in the trial is a major milestone, as it marks the completion of the patient assessment period and the beginning of the process of compilation, data analysis and reporting of top-line primary endpoint results for this key Phase IIb clinical trial of NTx(R)-265 in acute stroke.
Dr. Alan Moore, President and CEO, commented as follows: "With the last patient completing their 90-day observation endpoint, the modified REGENESIS- Phase IIb stroke trial enters into the exciting stage of data analysis and the reporting of top-line results. This exhilarating period in the Company's development is the culmination of solid support from the Company's shareholders, management and research and development team.”
“SCT looks forward with great anticipation to the soon to be announced top-line results of the modified REGENESIS- trial as this truly marks a key milestone in the development of this new therapy for stroke patients. With enrollment of the modified Phase IIb stroke trial ended and data analysis commencing top-line results are expected within the next 4 weeks, significantly earlier than the "end of Q2" target that we previously discussed."
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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