The time has come for DCVax to change the standard measurements of cancer.
DCVax is ground breaking as a multi-antigen targeting lysate-pulsed immunotherapy. I believe we have seen a different set of morphological changes within the tumor's microenvironment as demonstrated in the recent Compassionate Use arm of 55 "sickest of the sick".
Within this arm, 25 enrollees, that were not quantifiable as to the status of their cancer, did not fit into the previous catagories of progression.
I would argue that this has an associative corollary; that the DCVax treatment likely generates results that are outside and beyond the neat definitions of Resist Criteria.
As such I would support Ms. Powers in any effort to move the standards away from the chemo/rad oriented measurements of Resist 1.0 and 1.1.
DCVax attacks tumors with a unique methodology. This needs to be argued before the FDA now. Ms. Powers competently guided us through the earlier remarkable P III trial modification, once it was learned that there was a clearly quantifiable subset previously unknown to exist. (Those with immune systems compromised BECAUSE of SOC.)
I now realize that the long awaited first interim, may be delayed, due to this very circumstance. The interim is triggered by events. Events of death or progression. While death is the ultimate event and easily measured, it is now clear to me that DCVax induced morphological changes within the tumor's microenvironment LIKELY DO NOT FIT into the previously available catagories of progression. Something new and wonderful is happening within these enrollees tumors and their bodies. I conclude that NWBIO may already be in discussions with the FDA, or shortly will be, on this issue. This may be the missing link in understanding the time frame that the "L" trial is in. I would like to hear your opinions of this theory.
