Northwest Biotherapeutics initiates phase I/II trial
Northwest Biotherapeutics, a developer of non-toxic DCVax personalized immune therapies for solid tumor cancers, has announced 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.
It is anticipated that multiple centers in both the U.S. and U.K. will be joining as trial sites.
DCVax-Direct offers a potential new treatment option for clinical situations in which patients' tumors are considered inoperable either because of the location or type of cancer, or because of the spread of multiple tumors.
The trial is expected to enroll groups of patients with numerous types of cancers, including pancreatic, colon, liver and melanoma.
The trial is a combined phase I/II trial. In phase I, various dose levels of DCVax-Direct will be tested. The trial will then proceed directly into phase II to test the efficacy of the DCVax-Direct treatment. The primary endpoint for measurement of efficacy will be tumor regression (i.e., shrinkage or elimination).
This trial will not be blinded—the clinical results in patients will be seen as the trial progresses. Early results of the trial may emerge throughout 2013.
The key to DCVax-Direct is the use of partially matured dendritic cells. These specially prepared dendritic cells have the ability to pick up tumor antigens (i.e., tumor biomarkers) from tumor cells inside the tumor after the dendritic cells are directly injected into the tumor. After picking up the antigens, these dendritic cells also have the ability to travel to lymph nodes and mobilize the immune system to attack tumors throughout the body which express these antigens. Northwest Biotherapeutics holds patent coverage on both the manufacturing processes and the use of such partially matured dendritic cells.