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DCVax(R)-Brain is a groundbreaking personalized vaccine that takes apatient's own immune cells and trains them in the laboratory to attack thebiomarkers from that patient's own tumor cells. The 10-day manufacturingprocess produces several years of personalized vaccine for a patient, makingDCVax(R)-Brain an "off-the-shelf" product for that patient throughout thetreatment period. DCVax(R)-Brain is administered as a simple injection underthe skin, similar to a flu shot, and is not toxic as chemotherapies are.
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The most recent data provides an update for the period since December 31,2007, concerning both disease progression and overall survival. During thatperiod, only one of the nineteen patients experienced disease progression (at59.5 months), and only one patient died (at 37.8 months).
The long term data from these clinical trials shows that more than 80% ofthe patients who received DCVax(R)-Brain showed a clinical response. Incontrast, the typical response rates for cancer drugs are in the range of 20to 25% of patients, and have been as low as 13% of patients with some approvedcancer drugs.
DCVax(R)-Brain is now in a large, Phase II clinical trial designed andpowered as a pivotal trial, which is currently enrolling patients at 11medical centers across the U.S. (listed at http://www.nwbio.com).
Two leading physicians participating in the trial had the following tosay:
"For the first time in the fight against cancer, we are not using a toxicapproach to treatment. DCVax(R)-Brain uses patients' own immune cells and owntumor material, and does not cause the kinds of toxic side effects seen withtypical cancer treatments. DCVax-Brain is helping lead the way to new patient-friendly treatment approaches," said Dr. Michael Gruber, Clinical Professor ofNeurology and Neurosurgery, NYU Cancer Institute in New York and OverlookHospital in New Jersey, two of 11 sites of the clinical trial.
"The ongoing results from the prior clinical trials with DCVax(R)-Braincontinue to be very encouraging and exciting. This experimental treatment isbreaking new ground in the extension of patients' survival with the mostlethal form of brain cancer. This revolutionary approach may allow ourpatients to live longer, healthier, productive lives," said Dr. Steven Brem,Chief, Neuro-Oncology and Director of Neurosurgery at the H. Lee MoffittCancer Center and Research Institute in Tampa, FL, another active site in theclinical trial.
Since 2005, the standard of care for patients with newly diagnosed GBM hasbeen surgery followed by a combination of radiation and Temodar(R). Thestudies defining this standard of care achieved a median time to progressionof 6.9 months and a median overall survival of 14.6 months (Stupp, et. al., NEngl J Med, 352:987, 2005, n = 573). Further data from UCLA has demonstrated asomewhat longer median time to progression of 8.1 months, and median overallsurvival of 17.0 months, in selected patients wit
