DCVax®-Brain is an experimental autologous cellular therapy designed to create a specific immune response against a patient’s cancer. DCVax®-Brain utilizes a patient’s own dendritic cells (DC), and an extract of the patient’s own tumor cells to achieve an immune response. The tumor from surgery is shipped to a manufacturing facility, as are blood cells, in order to prepare the DCVax®-Brain. DCVax®-Brain is then shipped frozen to the clinic for administration to the patient. DCVax®-Brain is usually manufactured in sufficient quantities for treatment of at least one year, and often for two or more years.
Posted on: 08/03/2010
BETHESDA, Md., Aug. 3 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") (OTC Bulletin Board: NWBO) today announced further positive long-term follow-up data from its prior Phase I and Phase I/II clinical trials, in which patients with newly diagnosed Glioblastoma multiforme ("GBM"), the most rapid and lethal type of brain cancer, were treated with NWBT's DCVax®-Brain personalized immune therapy.
The data through July 1, 2010, show that no patients died during the 9-month period since the last data update (throughSeptember 2009). The data also show that median survival was 3 years, 33% of the patients reached 4-year survival, and 27% reached or exceeded 6-year survival (up from 22% who had reached or exceeded 6-year survival as of the last data update). The longest surviving patient to date has now exceeded 10 years.
GBM is a highly lethal cancer: with standard of care treatment (including surgery, radiation and chemotherapy), patients with newly diagnosed GBM have a median survival of only about 14.6 months, and less than 5% of such patients are still alive at 5 years.
"We're excited and encouraged by the continued extension of survival in the patients who received DCVax® in the prior clinical trials," commented Dr. Al Boynton, NWBT's CEO, "especially since DCVax® is non-toxic, unlike chemotherapies, and involves just a simple injection under the skin, like a flu shot."
DCVax®-Brain is a groundbreaking personalized vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax®-Brain is made up of the patient's own "dendritic cells," the master cells which direct the immune system, that have been activated and "educated" to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells.
The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells, along with certain other proprietary steps, in order to activate and "educate" the patient's dendritic cells. These activated and "educated" dendritic cells are injected back into the patient, in a simple small injection under the skin in the upper arm, similar to a flu shot or insulin shot. These cell treatments are administered at a series of time points several weeks apart and then months apart. The dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicities of the kind associated with chemotherapies.
Why do you have to travel to Israel? Clinical
trial studies are ongoing at UCLA for the DCVax, however currently the clinical trial is only accepting newly diagnosed GBM patients. Since
Cathy has been diagnosed with recurrent GBM she unfortunately does not does not qualify for the
clinical trial studies within the United States. Under a compassionate care agreement between UCLA and The International Center for Cell Therapy & Cancer Immunotherapy (CTCI) located in Tel Aviv, this vaccine is available for Cathy. The company that manufactures the DCVax is also the supplier of the vaccine in Israel. The DCvax is not covered under medical insurance as in the United States the DCVax is still considered an investigational treatment option until it becomes FDA approved following completion of the clinical trial studies. CTCI provides several types of dendritic cell vaccines. These are all “therapeutic” vaccines, which patients take after they already have cancer, rather than preventive vaccines. The vaccines are made from two main ingredients: dendritic cells (master immune cells) plus antigens (biomarkers) of the cancer being treated. The immune cells are obtained through a blood draw, and may be the patient’s own cells or cells from a healthy family member or other donor. The biomarkers are obtained from the patient’s own tumor tissue if such tissue is available. If not, then the biomarkers are obtained from a bank or library, or are produced recombinantly. In cancer patients, the dendritic cells have become impaired and are failing to mobilize the immune system to attack the cancer effectively. Dendritic cell vaccines are designed to activate dendritic cells so that they, in turn, can accomplish this mobilization of the whole immune system. The International Center for Cell Therapy & Cancer Immunotherapy (CTIC ):