Additional information regarding to PI-88 interim analysis
Independent Data Review Board has conducted interim analysis for PI-88 on July 27th, 2014 based on 136 patients in Phase III trial.
Based on the interpretations of tumor recurrence from 25 medical hospitals, the result has not yet achieved statistical significance on primary endpoint, Disease Free Survival (DFS).
All the data will be aggregated by BioClinica, a Pennsylvania-based company to conduct centralized MRI and CT analysis, which will be key reference for future study of Phase III clinical trial.
PI-88 Phase III clinical trial is still ongoing in 25 clinical medical centers. Final analysis of the PI-88 Phase III trial is expected to conduct in 2015 or later.
The analysis will determine whether PI-88 meets its primary and secondary endpoints: Disease Free Survival (DFS), Time to Recurrence (TTR), Tumor Recurrence Rate (TRR) and Overall Survival (OS).