Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") (OTC Bulletin Board: NWBO) today announced further long-term follow-up data, for the period from January through September 2009, from its prior Phase I and Phase I/II clinical trials conducted at UCLA with DCVax®-Brain in patients with Glioblastoma multiforme ("GBM"). GBM is the most rapid and lethal type of brain cancer. During the update period, only one of the twenty patients treated with DCVax®-Brain (in addition to standard of care) died, and that patient had survived for nearly 7 years (80.5 months). Overall, 85% of the patients treated with DCVax®-Brain in the Company's prior trials have lived longer than the median survival of only 14.6 months which is achieved with the full standard of care treatment available today (i.e., surgery plus radiation and chemotherapy). Furthermore, 22% of the patients treated with DCVax®-Brain have now reached or exceeded the 6-year survival mark. With standard of care treatment, less than 5% of GBM patients are still alive at 5 years.
The median survival time of the patients treated with DCVax®-Brain in the prior trials is 36.4 months. The difference between this median survival and the median survival achieved with full standard of care treatment has a "p value" of 0.0004. This means that, as a matter of statistical significance, there is only a 4 in 10,000 chance that the DCVax® results are random.
In addition to showing such extended survival, patients treated with DCVax®-Brain in the prior clinical trials have shown striking delays in progression (recurrence) of their cancer. Typically, in spite of surgical removal of the initial tumor, as well as radiation and chemotherapy, GBM brain tumors recur in just 6.9 months. In contrast, in the patients treated with DCVax®-Brain in NWBT's clinical trials, so far 74% of the patients have been free of recurrence for 1 year, 45% recurrence-free for 2 years, 33% recurrence-free for 3 years, 28% free for 4 years and 22% free for 5 years.
The median time to disease progression (recurrence) in the patients treated with DCVax®-Brain in the prior trials is 26.4 months. The difference between this median and the median time to progression achieved with full standard of care treatment has a "p value" of 0.00001. This means that, as a matter of statistical significance, there is only a 1 in 100,000 chance that the DCVax® results are random.
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 in the upper arm, under the skin, 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.