Stem Cell Therapeutics Corp. Announces Top-Line Results for the Modified REGENESIS Phase IIb Stroke Trial
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Stem Cell Therapeutics Corp. has announced the top-line results for the modified REGENESIS-Phase IIb stroke trial. 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.
SCT reports that the top-line primary endpoint results for this Phase IIb clinical trial of NTx®-265 in acute stroke showed that there was substantial improvement in the primary endpoint absolute change in NIHSS in both placebo treated patients and those receiving NTx®-265 with no statistical differences between the groups.
"The profile and magnitude of the placebo response is extremely surprising and merits further examination" said Dr. Alan Moore, CEO and President of Stem Cell Therapeutics. "We are currently conducting a validation review process of the full trial. We expect to report on the outcome of this within the next 2-3 weeks, together with results from a number of secondary endpoints such as modified Rankin and Barthel index, which may provide an alternative to NIHSS as a pathway forwards."
The results show that NTx®-265 was well tolerated in treated patients with no adverse affect on mortality. Of the 96 patients enrolled in the trial, 72 patients were administered a course of NTx®-265, sequential administration of human chorionic gandotropin (hCG) followed by erythropoietin (EPO), with the first dose at 24-48 hours after stroke onset while 24 patients were treated with placebo.
All patients were then monitored for 90 days. The top-line data show that the NTx®-265 treated group showed a drop of 6.3 +/- 0.5 NIHSS compared to placebo drop of 7.3 +/- 0.9 NIHSS. This difference was not statistically significant. Additionally, none of the individual dose groups showed a statistically significant effect compared to placebo.
SCT reports that the top-line primary endpoint results for this Phase IIb clinical trial of NTx®-265 in acute stroke showed that there was substantial improvement in the primary endpoint absolute change in NIHSS in both placebo treated patients and those receiving NTx®-265 with no statistical differences between the groups.
"The profile and magnitude of the placebo response is extremely surprising and merits further examination" said Dr. Alan Moore, CEO and President of Stem Cell Therapeutics. "We are currently conducting a validation review process of the full trial. We expect to report on the outcome of this within the next 2-3 weeks, together with results from a number of secondary endpoints such as modified Rankin and Barthel index, which may provide an alternative to NIHSS as a pathway forwards."
The results show that NTx®-265 was well tolerated in treated patients with no adverse affect on mortality. Of the 96 patients enrolled in the trial, 72 patients were administered a course of NTx®-265, sequential administration of human chorionic gandotropin (hCG) followed by erythropoietin (EPO), with the first dose at 24-48 hours after stroke onset while 24 patients were treated with placebo.
All patients were then monitored for 90 days. The top-line data show that the NTx®-265 treated group showed a drop of 6.3 +/- 0.5 NIHSS compared to placebo drop of 7.3 +/- 0.9 NIHSS. This difference was not statistically significant. Additionally, none of the individual dose groups showed a statistically significant effect compared to placebo.
