BETHESDA, Md., June 13, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing non-toxic DCVax ® personalized immune therapies for solid tumor cancers, announced today 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.
DCVax-Direct offers a potential new treatment option for the many 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. A large number of patients with lung, colon, pancreatic, liver, ovarian, melanoma, head and neck, and other cancers such as sarcomas face this situation today, and it carries a bleak prognosis.The excellent reputation and broad experience of the clinical trial team at MD Anderson makes them an ideal choice to initiate this study. It is anticipated that multiple other leading centers in both the US and UK will be joining as trial sites as well. Since the Company's announcement of plans for this trial, NW Bio has received inquiries from both patients and medical centers across the country seeking to participate. 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 (i.e., shrinkage or elimination). 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.
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