NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

"It is most certainly not the case that CLDX only enrolled patients after they showed a response to the treatment. That would be completely useless for a randomized trial."
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I based what I said on my recollection of Celldex's published descriptions of the trial on their company website about 18 months ago. To me, it was very misleading the way it was presented because the efficacy percentages were really for the small number of patients that had the right genetics and were let into the trial, but that was obscured in their text, and in the statements I heard made by Cramer as he praised the results thus far.

Currently, the Celldex web-site states:

"ACT IV is a 2-arm, randomized, Phase 3 study investigating the efficacy and safety of the addition of rindopepimut to the current standard of care, temozolomide, in patients with recently diagnosed EGFRvIII-positive glioblastoma"

http://www.celldex.com/clinical-trials/brain-cancer-clinical-trials.php

What I read in the past was that their method of determining whether the patients were EGFRvIII-positive was injecting the patients and looking at the subsequent changes to titers. Maybe I am wrong about what they were injecting, but they were injecting them and looking at the resulting immune response. That was part of the screening before enrollment. They didn't do DNA analysis, for instance, to see if the patients were EGFRvIII-positive.

So, what were they injecting as part of screening?