Wednesday, February 09, 2022 2:53:36 PM
The primary measure was safety
It was designed as a PhI/II, but the PhII stage (n=20) never happened.
''The Phase I stage of the trial involves dose escalation, testing 3 different dose levels of DCVax-Direct, and confirmation of the optimal dose. The Phase II stage of the trial will focus on efficacy. The primary measure of efficacy will be regression (i.e., shrinkage or elimination) of the patient’s existing inoperable tumors. Such regression is a rapid endpoint: if it is going to occur, is anticipated to occur within a couple months of treatment.'' https://nwbio.com/dcvax-direct/
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