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Re: Evaluate post# 21820

Wednesday, 10/22/2014 2:23:07 PM

Wednesday, October 22, 2014 2:23:07 PM

Post# of 690942
This happened back when DCVax-L was very young, and due to the success they were having, they went back to the FDA to ask that extended treatment be allowed.

Fairly recently, I think it was Bosch said patients could keep taking Direct boosters for the rest of their life if they needed to.

Unless I missed it, this is a question that would be helpful to get an answer to for the phase two multiple injection per procedure DCVax-Direct trial starting this fall.


General Thoughts of late.

(In the phase I Direct trial, if a certain percentage of patients demonstrate complete remission by the 6th injection, no alternative medical treatment would necessarily be needed for them -- except perhaps Direct boosters.)

(Note: the 4th, 5th and 6th injections are considered mandatory "boosters." This is very intriguing IMHO.)

(That OHSU study also gave us insight that really great results can happen to patients still demonstrating pseudo progression beyond 3 months. 3 months is in between the third and fourth injections, so I would think researchers would be encouraged where they are still seeing pseudo progression in some patients after the 4th injection. Of course, pseudo-progression is not necessary in every successfully responding patient. )

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