Dosing schedule after commercialization of DCVax-L?
Watching Dr. Marnix Bosch present his findings on rapid progressors, I was struck by his recollection of surprise regarding the strong results they were obtaining in the information arm. You see, not only did these types of patients not respond to all other therapies upon rapid progression, rapids did not respond to DCVax-L either -- until the information arm that is. I went back to look at the older DCVax-L trials, and in the cases where data was available, a high percentage of rapids REALLY did not appear to respond to DCVax-L.
However, in the more recent information arm, many rapids do respond! Dr. Marnix Bosch suggests this detectable difference from nonresponse to response is due to booster shots. The older phase I/II trials did not utilize booster shots
The current phase III dosing schedule is as follows.
0, 10, 20, (days) and at weeks 8, 16, 32, 48, 72, 96 and 120.
Notice something? The first 6 doses are scheduled similar to DCVax-Direct phase I. In particular, doses 4, 5 and 6.
Now ask yourself, what is one of the main improvements NWBO intends to make in the phase II DCVax-Direct Trials?
That's right, they expect better and faster results by scheduling the doses 2 to 3 weeks apart!
Now, because DCVax-L and DCVax-Direct are injected at different sites in the body, one might argue there may be some reason a systemic subdermal injection may have unknown limits regarding potential dosing ramp adjustment.
However, if DCVax-L dosing can be increased to biweekly, the German H.E. program may be the first place we start seeing even better responses! I do not know if Germany has flexibility along these lines, but if I were the PEI, I'd be all over it.
Finally, any phase IV open label confirmation trial could indeed use this schedule. If it does, I expect DCVax-L biweekly efficacy may very well surpass the old dosing schedule by a wide margin!
This is the one of many major advantages a safe drug like DCVax-L brings to the table.
Good Day.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
