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Thursday, December 19, 2013 4:05:01 PM
1. He raised a very important point when he stated it bodes well for NWBO that the patients in the IMUC trial with more matching antigens fared better. Why? because DCVAX-L uses a full set of antigens thus avoiding the potential of excluding patients.
2. He clouded the fact that DCVAX-L presents potentially hundreds more tumor antigens by inserting his angels on the head of a pin analogy. This was a bit of hyperbole -- even though well meaning.
3. In the NWBO 2002 phase 1 trial, there was a treatment gap for smooth continuation of booster shots. This was due to the fact that NWBO had to go back to the board and ask permission to extend booster shots. This bodes well for phase three because there will be no treatment gap, and due to the fact that the literature states one of the advantages for loaded ex vivo and/or loaded in vivo dendritic cells is that their numbers can be exponentially grown outside the body and then placed back into the body for an overwhelming immune response to the tumor, continued dominance over recurrence without a gap in phase 3 treatment could give additional benefit.
4. The 33 patients that are clearly considered part of the trial will likely improve the results due to the long tail of survival. In other words, while the pause in the trial from 2009 - 2011 was made to create an applicable placebo for the treatment arm to allow the study to become blinded, the 33 patients from 2008 were still treated and will be used for statistical analysis in the interim and final results. Patients who respond to DCVAX have a significantly longer OS (and tail of survival) than the control group. This is good news, and believe me, IMUC could have used longer analysis before announcing their results. (Note: Apparently only the control arm knew whether or not they were not getting treatment prior to 2009).
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