SSS reported that the top-line analysis for this clinical trial of NTx® 265 in acute stroke showed that there was substantial improvement in the primary efficacy endpoint (absolute change in NIHSS) in both placebo treated patients and those receiving NTx® 265, with no statistical differences between the groups. This modified REGENESIS-Phase IIb stroke trial is a placebo controlled; double blinded, 3:1 randomized clinical study that had enrolled 96 patients with acute ischemic stroke between 8/09 and 1/24/10.
After further analysis of the trial results, management has been unable to determine a definitive explanation for the unexpectedly large placebo effect encountered in the modified REGENESIS-Phase IIb stroke trial. Further analysis has, however, indicated that some of the secondary endpoints that were also measured as part of the trial demonstrate a trend that shows greater efficacy in those patients who received the NTx® 265 therapy versus those who were given the placebo.
None of these secondary endpoints had sufficient patient populations to demonstrate statistically significant differences; nevertheless the trends are considered by management to be encouraging. Analysis of the trial results is ongoing and all calculations are subject to validation in the final report which is expected to be completed by the end of August.
In light of these positive trends, and the excellent safety profile for NTx® 265 as demonstrated by the modified REGENESIS-Phase IIb stroke trial, SSS believes that it would be worthwhile to proceed to an end-of-Phase II meeting with the FDA in which they will seek approval to proceed with a Phase III stroke study for NTx® 265. SSS’s objective is to have such meeting in October of this year. There can be no assurance that the FDA will grant approval for a Phase III stroke trial.