Phase I and Phase I/II DCVax-Brain Data Continues to Show Significantly Improved Survival Rates for Brain Cancer PatientsYear-end 2007 long-term follow-up data continues to be positive
BETHESDA, Md., February 20, 2008 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") today announced the most recent long-term follow-up data, as of year-end 2007, on disease progression and overall survival in patients taking part in its Phase I and Phase I/II clinical trials for newly diagnosed patients with Glioblastoma multiforme ("GBM"), the most aggressive form of brain cancer. The additional data covers the period from April 2007 through year-end 2007. During this time, none of the patients experienced disease progression (recurrence) and only one patient died (at 36.4 months). Thus, the data show that in the 19 clinical trial patients receiving DCVax(R)-Brain in addition to Standard of Care, both the median overall survival and the median time to disease progression (recurrence) are more than twice as long as in patients receiving the Standard of Care for GBM. Dr. Linda Liau, Associate Professor of Neurosurgery and Director of the Malignant Brain Tumor Program at the UCLA School of Medicine ("UCLA"), served as the Principal Investigator for the trial.
Since 2005, the Standard of Care for patients with GBM is surgery followed by a combination of radiation and daily Temodar(R) chemotherapy, and then 6 monthly cycles of Temodar chemotherapy. 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). Further data from UCLA have demonstrated a somewhat longer median time to progression of 8.1 months and median overall survival of 17.0 months in patients with GBM who received Standard of Care.
The year-end 2007 data obtained by the Company concerning the 19 patients from the two trials at UCLA with newly diagnosed GBM continue to be positive, with no patients progressing and only one patient dying (at 36.4 months). Overall, the long-term follow-up data are now as follows:
o 8 of 19 patients are still alive (ranging from 24.5 months to 92 months), with median overall survival in all patients of 33.8 months (p < 0.0079) (the "p value" measures the likelihood that the observed clinical effect is due to chance: a 'p' value of 0.0079 means that there is a less than 1% possibility that the longer survival time of DCVax(R)-Brain-treated patients is due to chance); o 5 of the 8 patients who are still alive show no signs of cancer recurrence, with follow-up time ranging from 41 months to 92 months; o The median time to progression (i.e. tumor recurrence) is 18.1 months, compared to 8.1 months for patients treated at UCLA during the same time period (p = 0.00001); o 90% of patients have surpassed the Standard of Care median time to progression of 8.1 months; o 84% of patients have surpassed the Standard of Care median overall survival time of 17.0 months; o To date, 68% of patients receiving DCVax(R)-Brain in addition to Standard of Care have lived longer than 2 years, 42% have lived longer than 3 years, and 26% have lived longer than 4 years (48, 54, 57, 62 and 92 months so far);
"Findings such as these, where we are seeing 68% of our DCVax(R)-Brain-treated patients with GBM alive after two years, and 26% alive for more than 4 years (and counting) reinforce our belief that DCVax(R)-Brain may make a significant difference in the lives of patients with GBM," stated Dr. Alton L. Boynton, President and Chief Executive Officer of Northwest Biotherapeutics. "We believe that the results to date are particularly striking, and we plan to give patients continued booster injections at 3 month intervals. We believe that these booster injections will further enhance and sustain the patient's immune response in attacking the cancer and preventing or delaying its recurrence."
GBM, the most aggressive form of brain cancer, is estimated to have caused over 12,000 deaths in the US 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 currently approved by the Food and Drug Administration ("FDA"). Those treatments have been shown in clinical trials to add only 10-12 weeks of survival in GBM patients. In contrast, in the two clinical trials conducted at UCLA with DCVax(R)-Brain, the patients have experienced much longer extensions of the time to disease progression (recurrence) and overall survival.
DCVax(R)-Brain is a type of 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 that have been "educated" to recognize and destroy cancer cells bearing the biomarkers of the patient's 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, 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 has initiated a large Phase II clinical trial of DCVax(R)-Brain that is designed and powered to serve as a pivotal trial in support of potential product registration. The trial is currently screening and enrolling patients at a number of sites across the U.S.
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, 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: Anthony Deasey, Northwest Biotherapeutics, Inc., +1-240-497-9036
Web site: http://www.nwbio.com/
Ticker Symbol: (:NWBT),(:NWBT)
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Posted: February 2008