Northwest Biotherapeutics initiates DCVax-Direct Phase I/II trial

Northwest Biotherapeutics announced that its 60-patient Phase I/II clinical trial of DCVax-Direct for all inoperable solid tumor cancers has been initiated at The University of Texas MD Anderson Cancer Center in Houston, Texas. The trial is expected to enroll groups or "cohorts" of patients with numerous different types of cancers, including pancreatic, colon, liver, melanoma, and various other cancers. The trial is a combined Phase I and II trial. In the Phase I stage, the trial will test various dose levels of DCVax-Direct. The trial will then proceed directly into the Phase II stage to test the efficacy of the DCVax-Direct treatment. The primary endpoint for measurement of efficacy will be tumor regression. As is standard with Phase I/II trials, this trial will not be blinded – the clinical results in patients will be seen as the trial progresses. Accordingly, it is anticipated that early results of the trial may be emerging throughout the remainder of 2013.