Long-Term Phase I and Phase I/II Trial Data Continue to Show Striking Improvement in Survival of Brain Cancer Patients Who Receive DCVax-Brain
BETHESDA, Md., September 11, 2008 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") today announced the most recent long-term follow-up data, through June 15, 2008, from its prior Phase I and Phase I/II clinical trials with DCVax(R)-Brain, which began in 2000 and 2003, for patients with Glioblastoma multiforme, the most lethal type of brain cancer. This long-term data shows that 84% of patients who received DCVax(R)-Brain in these trials have so far lived longer than the median survival of 14.6 months under standard of care, 68% of the patients have so far lived more than 2 years, 58% of the patients have so far lived more than 2-1/2 years, 42% have so far lived more than 3 years, and 26% have so far lived more than 4 years, with patients surviving as long as 8 years to date. The median survival in the patients from these trials is now 36.4 months, under a standard Kaplan Meier analysis.
DCVax(R)-Brain is a groundbreaking personalized vaccine that takes a patient's own immune cells and trains them in the laboratory to attack the biomarkers from that patient's own 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 chemotherapies are.
The most recent data provides an update for the period since December 31, 2007, concerning both disease progression and overall survival. During that period, only one of the nineteen patients experienced disease progression (at 59.5 months), and only one patient died (at 37.8 months).
The long term data from these clinical trials shows that more than 80% of the patients who received DCVax(R)-Brain showed a clinical response. In contrast, the typical response rates for cancer drugs are in the range of 20 to 25% of patients, and have been as low as 13% of patients with some approved cancer drugs.
DCVax(R)-Brain is now in a large, Phase II clinical trial designed and powered as a pivotal trial, which is currently enrolling patients at 11 medical centers across the U.S. (listed at http://www.nwbio.com).
Two leading physicians participating in the trial had the following to say:
"For the first time in the fight against cancer, we are not using a toxic approach to treatment. DCVax(R)-Brain uses patients' own immune cells and own tumor material, and does not cause the kinds of toxic side effects seen with typical cancer treatments. DCVax-Brain is helping lead the way to new patient- friendly treatment approaches," said Dr. Michael Gruber, Clinical Professor of Neurology and Neurosurgery, NYU Cancer Institute in New York and Overlook Hospital in New Jersey, two of 11 sites of the clinical trial.
"The ongoing results from the prior clinical trials with DCVax(R)-Brain continue to be very encouraging and exciting. This experimental treatment is breaking new ground in the extension of patients' survival with the most lethal form of brain cancer. This revolutionary approach may allow our patients to live longer, healthier, productive lives," said Dr. Steven Brem, Chief, Neuro-Oncology and Director of Neurosurgery at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, FL, another active site in the clinical trial.
Since 2005, the standard of care for patients with newly diagnosed GBM has been surgery followed by a combination of radiation and Temodar(R). The studies defining this standard of care achieved a median time to progression of 6.9 months and a median overall survival of 14.6 months (Stupp, et. al., N Engl J Med, 352:987, 2005, n = 573). Further data from has demonstrated a somewhat longer median time to progression of 8.1 months, and median overall survival of 17.0 months, in selected patients with GBM who received the same standard of care (n = 119).
In comparison, the long-term follow-up data as of June 15, 2008, for patients who received DCVax(R)-Brain in the two prior clinical trials is now as follows:
-- The median overall survival in patients from these two trials is now 36.4 months, as determined by standard Kaplan Meier analysis;
-- The median time to disease progression (tumor recurrence) is now 18.1 months;
-- 90% of the patients for these trials patients have surpassed the standard of care median time to progression of 6.9 months;
-- 84% of the patients have surpassed the standard of care median overall survival time of 14.6 months;
-- To date, 68% of patients receiving DCVax(R)-Brain in addition to standard of care have lived longer than two years, 58% have lived longer than 2 1/2 years, 42% have lived longer than three years, and 26% have lived longer than four years;
Dr. Alton L. Boynton, President and Chief Executive Officer of NWBT commented, "We continue to be encouraged by the long-term survival data of the patients treated in these studies, which suggest that treatment with DCVax(R)- Brain has the potential to more than double the time to tumor recurrence, and more than double survival time for patients suffering from this dreadful disease."
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"). Those treatments have been shown in clinical trials to typically add only 10-12 weeks of survival in GBM patients.
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 "educated" 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).
The Company previously announced on August 20, 2008, that it had approximately $1.1 million of cash on hand. The Company estimates that its available cash is sufficient to support its day to day operations through to the end of September 2008. It therefore needs to raise significant additional capital to fund its clinical trials and other operating activities and to repay indebtedness. The Company continues to be in late stage discussions with several parties in regard to additional financing transactions. Shareholders should be aware that if the Company's capital raising efforts are unsuccessful, this will have a material adverse effect on the Company financial position and operations.
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 designed and powered to serve as a pivotal trial. 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 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: Alton Boynton, +1-240-497-9024, for Northwest Biotherapeutics,Inc.
Web site: http://www.nwbio.com/
Ticker Symbol: (NASDAQ-OTCBB:NWBO),(NASDAQ-OTCBB:NWBO)
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Posted: September 2008