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Stem Cell Therapeutics Corp. Announces Completion of Further Analysis of the Modified REGENESIS Stroke Data


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Stem Cell Therapeutics Corp. announces that further analyses of the modified REGENESIS stroke data base have been completed. First, no dose-related treatment mortality was seen, confirming our earlier observations. Second, in those patients who received occupational therapy (OT) - approximately 25% of the total - the NTx®-265 regimen had a statistically significant beneficial effect on the National Institute of Health Stroke Score ("NIHSS", the defined primary endpoint in the study), showing a mean reduction of 5.1 points for placebo vs. 8.6 points for NTx®-265 therapy.

Additionally, in this subgroup, the effect of NTx®-265 was also statistically significant versus placebo on the secondary endpoint of modified Rankin and trended in favor of NTx®-265 for geriatric depression score, an important measure of "well being" in post-stroke patients.

Separately, in an analysis of the approximately 69% of patients who had one observer throughout the study versus multiple observers, all endpoints, primary and secondary, were in favor of the NTx®-265 regimen, although the effects were not as dramatic as that seen in the OT subgroup, and were not statistically significant. In the much smaller subgroup that combined criteria, OT plus a single observer, separation of drug and placebo effect was even more dramatic for NIHSS. Specifically, the NTx®-265 regimen reduced the NIHSS by a mean of 9.1 points whereas the placebo mean response was only 3.3 points, and again this difference was statistically significant.

Dr. Alan Moore, President & CEO of SCT stated "While these subgroup analyses were not pre-specified, they provide key information going forward with clinical evaluation of the NTx®-265 regimen, and in discussions with the FDA, on the importance of OT and one versus multiple assessors. Further, the OT findings appear to confirm the original mechanistic understanding of the NTx®-265 regimen - that it works by amplifying a natural process, the restructuring of neural functioning post stroke."

As stated previously, the Company continues to move forward as a biotech company considering a range of options, with management focusing its efforts on pursuing the end-of-Phase II meeting with the FDA for the NTx®-265 stroke therapy while concurrently reviewing alternatives for pursuing the traumatic brain injury (TBI) and multiple sclerosis (MS) study opportunities, as well as various external opportunities.
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