Friday, May 20, 2016 9:10:55 PM
This lymphocyte count correlation is significant not only for absolute count at screening but as it relates to longer term recovery to higher levels with time. NWBO wanted to make sure that those who could recover to higher levels were not having their results dragged down by those whose immune systems were being compromised because their lymphocyte count could not rise much over time even if their absolute count allowed them into the trial in the first place. As flipper44 said, SOC does not benefit from better lymphocyte count until they cross over so PFS benefit should correlate to prior lymphocyte count fairly well in the ITT population. Lymphocyte count may also correlate to the immunogenicity of the tumor type as well. Lymphocytes want to get to exposed tumor antigens and have the ability to access submerged antigens that will surface under the right conditions but are prevented from this activity because of improper activation due to cancer defense mechanisms. DCVax creates the right conditions for a short time with each vaccination. The improved dosing schedule, cell count and multiple injection sites will help.
Keep an eye on developments at Sawston. Just because NWBO may not be able to say much now does not mean we can't put expected time tables together. Three Phase 2s with rapid enrollment expected needs production ramped up and ready to go. I would imagine that best potential improvements (some may have been suggested by Dr. Linda Liau) will be built in as well. Best wishes.
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