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Table 2 Descriptive Statistics of FWPE/OTS Scores in Each FW Setting Historical Control Group Simulation Group N Mean SD N Mean SD Total 172 136.
The primary study objective, which was to extend the median survival time following tumor recurrence by three months compared to a historical control group, was significantly exceeded in the actual results.
The primary objective for the Nano-Cancer([R]) therapy study was to demonstrate an extension of the median survival time in the recruited patient group by three months compared to this historical control group.
The survival of a matched historical control group was 14.
The DSMB meeting was conducted after data relating to the primary and secondary efficacy endpoints (achievement of complete response and survival by day 100, respectively) had been collected on 46 patients in the Defibrotide treatment arm and 86 patients in the historical control group.
Vaccination with CDX-110 together with standard of care temozolomide in patients with glioblastoma multiforme increased time to progression and overall survival compared with a matched historical control group in these Phase 2 studies," said John Sampson, M.

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