BETHESDA, Md., March 5, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax ® personalized immune therapies for solid tumor cancers, announced today that its Phase I/II DCVax-Direct clinical trial for all inoperable solid tumor cancers is planned to begin within approximately the next sixty days. As a Phase I/II trial, this trial is not blinded and the results will be seen as the trial proceeds. With an efficacy endpoint of tumor regression (i.e., tumor shrinkage or elimination), this innovative trial is expected to yield meaningful ongoing results by the second half of 2013.
This clinical trial is approved by the FDA for all types of solid tumor cancers (i.e., cancers in any tissues of the body), and is configured to provide rapid results. In the Phase I portion, it will test both safety and a variety of dosing regimes, and will do so in multiple different cancers – avoiding the need to conduct separate Phase I studies in each such cancer, as is usually the case. Then, the trial will go directly into the Phase II portion, testing for efficacy, without the need for another FDA review.The endpoint for measuring efficacy in the Phase II portion of the trial will be tumor regression. This endpoint is a particularly important one clinically: once tumors are established, if they cannot be surgically removed, it is very difficult to stop their growth and their spread. This endpoint is also important from a regulatory standpoint: it is the endpoint used most frequently for FDA-granted accelerated approval. Further, this endpoint is a rapid one: typically, if tumor regression is going to occur, it is anticipated to be seen within a few months after treatment – far sooner than other clinical trial endpoints such as progression free survival (PFS) or overall survival (OS).