Northwest Biotherapeutics, Inc, announced longterm follow-up data for the second half of 2008, from its prior phase I and phase I/II clinical trials with DCVax-Brain in patients with glioblastoma multiforme. During the update period from June 15, 2008, through January 1, 2009, none of the 20 patients treated with standard of care plus DCVax-Brain died. So far, 68% of patients treated with DCVax-Brain have lived more than 2 years, 63% have lived more than 2½ 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.
In addition, only 2 of the 20 patients experienced progression or recurrence of their brain cancer. One of these two patients had been disease-free for nearly 6 years at the time of their progression, and the other patient had been disease-free for more than 4 years. The usual time to progression in glioblastoma, with full standard-of-care treatment but without DCVax-Brain, is only 6.9 months.
DCVax-Brain is a personalized vaccine that takes a patient’s own master immune cells and the biomarkers from that patient’s own tumor tissue, and activates the master immune cells so they can mobilize the full immune system to recognize and kill the tumor cells. The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax-Brain an “off-the-shelf” product for that patient throughout the treatment period. It is administered as an injection under the skin and is not toxic.
DCVax-Brain is now in a large phase II clinical trial that is enrolling patients at 11 medical centers across the United States (listed at http://www.nwbio.com/).