95% alive 14.6 months and 95% PFS 6.9 mo...2/20 progressed after 4 years...what was the primary end point for the trial again?
BETHESDA, Md., February 17, 2009 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics , Inc. ("NWBT" or the "Company") today announced further long-term follow-up data, for the second half of 2008, from its prior Phase I and Phase I/II clinical trials with DCVax-Brain (R) in patients with Glioblastoma multiforme, the most rapid and lethal type of brain cancer. During the update period from June 15, 2008, through January 1, 2009, none of the twenty patients treated with standard of care plus DCVax(R)-Brain died. So far, now, 68% of patients treated with DCVax(R)-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(R)-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 to there being no deaths among the DCVax(R)-Brain treated patients during the 2008 update period, only two of the twenty patients experienced progression (recurrence) of their brain cancer. One of these two patients had been disease free for nearly 6 years (70 months) at the time of their progression, and the other patient had been disease free for more than 4 years (50 months). In contrast, the usual time to progression (recurrence) in GBM, with full standard of care treatment but without DCVax(R)-Brain, is only 6.9 months.
In other results from the 2008 update data period:
-- 95% of DCVax(R)-Brain treated patients have lived longer than the
median survival of 14.6 months with existing standard of care
-- Likewise, 95% of DCVax(R)-Brain treated patients have been free of
disease progression (recurrence) for longer than the median progression
free survival of 6.9 months with existing standa
Dr. Lee Tessler, participating in a current late stage Phase III trial of the DCVax immune
therapy for brain cancer at the Long Island Brain Tumor Center, describes the process that begins
with surgical removal of the patient’s tumor. The patient's immune cells are then harvested and
exposed in the laboratory to the biomarkers taken from the patient's tumor. These conditioned
immune cells are then injected back into the patient through a simple injection under the skin in
the upper arm, similar to a flu shot. The conditioned (“educated”) immune cells then mobilize
the patient’s immune system to now fight any tumor cells bearing the same biomarkers wherever
such tumor cells are found in the body.
Great post!!!! Brain cancer patients need NWBO to be successful and this clearly shows just how striking the results achieved in the prior trials. Go on the cancer message boards and your heart goes out to the patients and caregivers fighting this dreaded disease and DCVax-L iMHO is going to be the next generation therapy for brain cancer.
Patriot... are the participants from the Phase 1 trail mentioned above part of the population for the Phase 3 trail? Curious is we get the benefit of those positive results in the overall pool of patients.