Promising new Clinical Trial for Treatment of Glioblasoma Multiforme (GBM) – Brain Cancer

Glioblastoma multiforme (GBM) is a form of brain cancer diagnosed in 10,000 americans annually. GBM accounts for over half of all primary brain tumor cases and is the most agressive form. Common method of treatment for GBM are  chemotherapy, radiotherapy, and surgery. These treatments are not a cure. According to Northwest Biothreaputics ( the standard of care for patients  since 2005 (that have been newly diagnosed with GBM) has been surgery followed by a combination of radiation and Temodar®. The studies that defined this standard of care achieved a median overall survival of 14.6 months (Stupp, et. al., New England Journal of Medicine, 352:987, 2005, n = 573).

Northwest Biotherapeutics, Inc. (NWBT) is in clinical trials with  DCVax®-Brain, which is a personalized immunotherapy designed to stimulate a patient’s own immune system to fight cancer. DCVax®-Brain is currently in a large Phase II clinical trial at 11 medical centers across the United States.  DCVax®-Brain requires an injection under the skin. It is not toxic.

Here is the exciting news. NWBT announced on February 17th results from its prior Phase I and Phase I/II clinical trials with DCVax®-Brain:

“During the update period from June 15, 2008, through January 1, 2009, none of the twenty patients treated with standard of care plus DCVax®- Brain died. So far, now, 68% of patients treated with DCVax®-Brain have lived more than 2 years, 63% have lived more than 2-1/2 years, 53% have lived more than 3 years, 35% have lived more than 4 years and 25% have lived more than 5 years. In contrast, patients who receive full standard of care (surgery, radiation and chemotherapy) without DCVax®-Brain have a median survival of only 14.6 months, and less than 5% of these patients are typically alive at 5 years.”

While this treatment is still in clinical trials, these statistics are very promising.“The long-term survival of patients treated with DCVax®-Brain continues to be quite striking and encouraging,” commented Dr. Alton L. Boynton, President and Chief Executive Officer of NWBT, “and it is especially exciting that this long-term survival is without toxicity, enabling our patients to go on with their lives in a normal fashion.”

How does it work?

The following is from a press release from NWBT describing the process:

DCVax®-Brain is made up of the patient’s own “dendritic cells,” the master cells of the immune system, that have been activated and “educated” to mobilize the full immune system to recognize and destroy cancer cells bearing the biomarkers of the patient’s own 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, along with certain other proprietary steps, and are thereby activated and “educated.” These activated and “educated” dendritic cells are injected back into the patient …  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).
DCVax® is a platform technology that can be applied to multiple cancers. It combines a patient’s own dendritic cells (DC) with cancer related proteins, or antigens, with the aim of inducing  immune responses against a patient’s cancer cells. Our early-stage clinical trial data, and those of our collaborators, suggest that DCVax®-Prostate and DCVax®-Brain may have the ability to significantly delay disease progression,

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