BETHESDA, M.D., Oct. 21 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (“NWBT” or the “Company”) (OTC Bulletin Board: NWBO - News) today announced further long-term follow-up data, for the period from January through September 2009, from its prior Phase I and Phase I/II clinical trials conducted at UCLA with DCVax®-Brain in patients with Glioblastoma multiforme (“GBM”). GBM is the most rapid and lethal type of brain cancer. During the update period, only one of the twenty patients treated with DCVax®-Brain (in addition to standard of care) died, and that patient had survived for nearly 7 years (80.5 months). Overall, 85% of the patients treated with DCVax®-Brain in the Company’s prior trials have lived longer than the median survival of only 14.6 months which is achieved with the full standard of care treatment available today (i.e., surgery plus radiation and chemotherapy). Furthermore, 22% of the patients treated with DCVax®-Brain have now reached or exceeded the 6-year survival mark. With standard of care treatment, less than 5% of GBM patients are still alive at 5 years.
The median survival time of the patients treated with DCVax®-Brain in the prior trials is 36.4 months. The difference between this median survival and the median survival achieved with full standard of care treatment has a “p value” of 0.0004. This means that, as a matter of statistical significance, there is only a 4 in 10,000 chance that the DCVax® results are random.
In addition to showing such extended survival, patients treated with DCVax®-Brain in the prior clinical trials have shown striking delays in progression (recurrence) of their cancer. Typically, in spite of surgical removal of the initial tumor, as well as radiation and chemotherapy, GBM brain tumors recur in just 6.9 months. In contrast, in the patients treated with DCVax®-Brain in NWBT’s clinical trials, so far 74% of the patients have been free of recurrence for 1 year, 45% recurrence-free for 2 years, 33% recurrence-free for 3 years, 28% free for 4 years and 22% free for 5 years.
The median time to disease progression (recurrence) in the patients treated with DCVax®-Brain in the prior trials is 26.4 months. The difference between this median and the median time to progression achieved with full standard of care treatment has a “p value” of 0.00001. This means that, as a matter of statistical significance, there is only a 1 in 100,000 chance that the DCVax® results are random.
DCVax®-Brain is a groundbreaking personalized vaccine designed to stimulate a patient’s own immune system to fight cancer. DCVax®-Brain is made up of the patient’s own “dendritic cells,” the master cells which direct the immune system, that have been activated and “educated” to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient’s own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells. The biomarkers from the patient’s tumor tissue are exposed to the patient’s immune cells, along with certain other proprietary steps, in order to activate and “educate” the patient’s dendritic cells. These activated and “educated” dendritic cells are injected back into the patient, in a simple small injection in the upper arm, under the skin, similar to a flu shot or insulin shot. These cell treatments are administered at a series of time points several weeks apart and then months apart. The dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicities of the kind associated with chemotherapies.
The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax®-Brain an “off-the-shelf” product for that patient throughout the treatment period. In addition, NWBT is developing automation of its manufacturing processes to further streamline them, enhance the economics and enable scale-up. NWBT’s contract manufacturer, Cognate BioServices, recently moved its DCVax® operations from Sunnyvale, California, to Memphis, Tennessee, reducing the costs and increasing the manufacturing capacity for DCVax®.
DCVax®-Brain has begun a 240-patient Phase II clinical trial, with 13 trial sites at medical centers across the U.S. The trial is not currently enrolling patients but expects to resume doing so soon.
“We are very pleased to see DCVax®-treated patients achieving years of extended survival and years of delays in recurrence of this terrible brain cancer,” commented Ms. Linda Powers, Chair of NWBT’s Board. “Also, we think it is especially important that these results are being achieved without toxicity, enabling our patients to go on with their lives in a normal fashion during these years.”
GBM, the most aggressive form of brain cancer, is estimated to cause more than 12,000 deaths per year in the U.S.; and brain cancer is estimated to cause over 39,000 deaths per year in Europe. 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.
The Company is in negotiations with several different providers for additional near-term funding and longer term funding, which it hopes to complete during H2 of 2009. The Company has raised $3.9 million this year to date, and the Company raised $8.15 million in 2008. The Company will need to continue raising additional capital to fund its clinical trials and other operating activities, and to repay indebtedness in due course. Shareholders should be aware that if the Company’s capital raising efforts are unsuccessful, this will have a material adverse effect on the Company’s 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 toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines and therapeutic antibodies. The Company’s lead clinical trial is a large Phase II trial in GBM. The Company has also received clearance from the FDA for a 600+ patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has also conducted a Phase I/II trial with DCVax® 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 www.nwbio.com.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax®-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, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings 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.
