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Phase I and Phase I/II DCVax(R)-Brain Data Continues to Show Significantly Improved Survival Rates for Brain Cancer Patients
Date:2/20/2008

tient's immune response in attacking the cancer and preventing or delaying its recurrence."

GBM, the most aggressive form of brain cancer, is estimated to have caused over 12,000 deaths in the US in 2007; and brain cancer is estimated to have caused over 39,000 deaths in Europe in 2002 (in each case the last year for which estimates are available). Beyond surgery to remove the brain tumor, and radiation therapy, there are only two treatments for GBM currently approved by the Food and Drug Administration ("FDA"). Those treatments have been shown in clinical trials to add only 10-12 weeks of survival in GBM patients. In contrast, in the two clinical trials conducted at UCLA with DCVax(R)-Brain, the patients have experienced much longer extensions of the time to disease progression (recurrence) and overall survival.

DCVax(R)-Brain is a type of personalized immunotherapy designed to stimulate a patient's own immune system to fight cancer. DCVax(R)-Brain is made up of the patient's own dendritic cells that have been "educated" to recognize and destroy cancer cells bearing the biomarkers of the patient's tumor. Each patient undergoes tumor removal through surgery as part of the current Standard of Care. Dendritic cells drawn from a sample of the patient's blood are exposed in a lab dish to the biomarkers of the patient's own tumor, and are thereby activated and "educated." These activated and "educated" dendritic cells are injected back into the patient, in a simple small injection under the skin similar to a flu shot or insulin shot, at a series of time points several weeks apart and then months apart. These dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicity to the patient (i.e., without grade 3 or 4 adverse events)

The Company has initiated a large Phase II clinical trial of DCVax(R)-Brain that is designed and powered to serve as a pivotal trial in support of potential product r
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SOURCE Northwest Biotherapeutics, Inc.
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