What the Phase 2 Ischemic Stroke Trial needs to show!!!
From Edison Research Report dated January 12, 2015
The following is a quote from the report:
Aside from a safety assessment (rate of dose limiting adverse events after seven days), the primary endpoint will measure relative changes between MultiStem and placebo groups in three widely accepted stroke scales: functional disability (modified Rankin Score), neurological deficit (NIH stroke scale) and activities of daily living (Barthel Index).
The primary focus of the study is to evaluate the relative difference in outcomes with regard to improvement among patients that have received MultiStem or placebo. Patients in the study are moderate to severely affected stroke patients and the aim is to evaluate good to excellent outcomes. The global assessment (using the three stroke scales) should therefore provide a more complete picture in terms of the improvement across cognition, motor skills and activities of daily living. The proportion of patients receiving MultiStem that show a clear and meaningful improvement in NIHSS, mRS and Barthel, will be compared to the same improvement percentage in the placebo group. Should that absolute difference (delta) in response rates between MultiStem and placebo be equal to or greater than that observed with tPA (11-20% on excellent outcomes in the Activase NINDS studies), while extending the treatment window to 2-3 days over the current 3-4 hours, MultiStem's potential as an important new therapeutic option for ischemic stroke would be confirmed. End Quote
That's it folks! If MultiStem is equal or better than the above tPA results, Athersys could be on the way to becoming the new worldwide standard of care for ischemic stroke.....a $15 Billion market in just the U.S. Europe and Japan.
