Update of Long-Term Data on Brain Cancer Patients Receiving DCVax-Brain Continues to Show Striking Improvements in Delay of Disease and Survival
BETHESDA, Md., February 17, 2009 /PRNewswire-FirstCall/ -- <!-- cpurl -->Northwest Biotherapeutics<!-- /cpurl -->, 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 <!-- ppurl -->DCVax-Brain<!-- /ppurl --> (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 treatment; -- 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 standard of care treatment.
DCVax(R)-Brain is a groundbreaking 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(R)-Brain an "off-the-shelf" product for that patient throughout the treatment period. DCVax(R)-Brain is administered as a simple injection under the skin, similar to a flu shot, and is not toxic as most chemotherapies are.
DCVax(R)-Brain is now in a large Phase II clinical trial which is currently enrolling patients at 11 medical centers across the U.S. (listed at http://www.nwbio.com).
"The long-term survival of patients treated with DCVax(R)-Brain continues to be quite striking and encouraging," commented Dr. Alton L. Boynton, President and Chief Executive Officer of NWBT, "and it is especially exciting that this long-term survival is without toxicity, enabling our patients to go on with their lives in a normal fashion."
GBM, the most aggressive form of brain cancer, is estimated to have caused more than 12,000 deaths in the United States in 2007; and brain cancer is estimated to have caused over 39,000 deaths in Europe in 2002 (in each case, the last year for which estimates are available). Beyond surgery to remove the brain tumor and radiation therapy, there are only two treatments for GBM patients currently approved by the U.S. Food and Drug Administration ("FDA"): one chemotherapy drug, and one drug-infused wafer for surgical implant. Those treatments have been shown in clinical trials to typically add only 10-12 weeks of survival in GBM patients.
Since 2005, the standard of care for patients with newly diagnosed GBM has been surgery followed by a combination of radiation and <!-- ppurl -->Temodar<!-- /ppurl -->(R). The studies that defined this standard of care, and formed the basis for the approval of Temodar(R), achieved a median overall survival of 14.6 months and a median time to disease progression (recurrence) of 6.9 months (Stupp, et. al., N Engl J Med, 352:987, 2005, n = 573).
As noted above, DCVax(R)-Brain is a personalized immunotherapy designed to stimulate a patient's own immune system to fight cancer. DCVax(R)-Brain is made up of the patient's own "dendritic cells," the master cells of the immune system, that have been activated and "educated" to mobilize the full immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes tumor removal through surgery as part of the current standard of care. Dendritic cells drawn from a sample of the patient's blood are exposed in a lab dish to the biomarkers of the patient's own tumor, along with certain other proprietary steps, and are thereby activated and "educated." These activated and "educated" dendritic cells are injected back into the patient, in a simple small injection under the skin, similar to a flu shot or insulin shot, at a series of time points several weeks apart and then months apart. These dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicity to the patient (i.e., without grade 3 or 4 adverse events).
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines and therapeutic antibodies. The Company is currently conducting a large Phase II clinical trial in GBM, which is currently open and enrolling patients at 11 sites across the U.S. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has started, and is currently enrolling patients in, a Phase I/II trial with DCVax(R) for recurrent metastatic ovarian cancer. The Company's second technology platform, involving antibodies to CXCR4, is at the late pre-clinical development stage.
For further information about clinical sites and Company information please visit the company web site at http://www.nwbio.com.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax(R)-Brain and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy. Additional information on these and other factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings and the Risk Factors section of the Form S-1 recently filed by the Company. Finally, there may be other factors not mentioned above or included in the Company's SEC filings or recently filed Form S-1 that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACT: Media, Alton Boynton of Northwest Biotherapeutics, Inc.,+1-240-497-9024
Web site: http://www.nwbio.com/
Ticker Symbol: (NASDAQ-OTCBB:NWBO),(NASDAQ-OTCBB:NWBO)
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Posted: February 2009
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