NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Hmm, I might even suggest that this trial has a disproportionate number of HIGH CD4 cell count patients. If at baseline in that study, lymphocyte counts were between 331 and 4,736, with medians of 1,044 for those below 200 CD4 at 2 months and 1,645 for those above 200 CD4, and it states that after SOC:

The median percentage reduction in CD4 counts at 2 months was 69% in all patients. Patients with baseline CD4 counts of more than 500 cells/mm3 fell by 72%, whereas those with baseline CD4 counts of less than 500 cells/mm3 fell by 49%. The reduction in CD4 counts paralleled changes in total lymphocyte counts..

Then, if they fell on average 72% for the 1,645 median group and 49% for the 1,044 group when checked at 2 months after SOC, then their medians were 460 and (oddly) 532 respectively, after SOC. So, only the upward bounds would get into the DCVax-L trial.

I just noticed IMUC's trial did NOT have this inclusion criteria:

absolute lymphocyte count >/=1,000/mm3

but rather:

Baseline hematologic studies and chemistry profiles must meet the following criteria:

Hemoglobin (Hgb) > 9.9 g/dL total granulocyte count > than 1000/mm3 platelet count > 100,000/mm3 blood urea nitrogen (BUN) < 30 mg/dL creatinine < 2 mg/dL alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN) prothrombin time (PT) and activated partial thromboplastin time (PTT) = 1.6x control unless therapeutically warranted

However this may have removed a number of them, as they are prone to infections (the study noted a decent % of them acquiring pneumonia):

Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed

The question is, how will including only HIGH lymphocyte functioning patients affect PFS/OS rates of control? Adjust modeling?