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March 5, 2013
08:17 EDTNWBONorthwest Biotherapeutics: DCVax-Direct trial to produce ressults in 2013
Northwest Biotherapeutics announced 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, this 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, 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.
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June 13, 2013
08:16 EDTNWBONorthwest Biotherapeutics initiates DCVax-Direct Phase I/II trial
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