Stem Cell Therapeutics Corp announced 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-265 in acute stroke.
Dr Alan Moore, president and CEO, said, "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 enrolment of the modified phase-IIb stroke trial ended and data analysis commencing top-line results are expected within the next four weeks, significantly earlier than the "end of Q2" target that we previously discussed."
Stem Cell Therapeutics is a public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.