BETHESDA, Md., Aug. 3 Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") (OTC Bulletin Board: NWBO) today announced further positive long-term follow-up data from its prior Phase I and Phase I/II clinical trials, in which patients with newly diagnosed Glioblastoma multiforme ("GBM"), the most rapid and lethal type of brain cancer, were treated with NWBT's DCVax®-Brain personalized immune therapy.
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The data through July 1, 2010, show that no patients died during the 9-month period since the last data update (through September 2009). The data also show that median survival was 3 years, 33% of the patients reached 4-year survival, and 27% reached or exceeded 6-year survival (up from 22% who had reached or exceeded 6-year survival as of the last data update). The longest surviving patient to date has now exceeded 10 years.
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GBM is a highly lethal cancer: with standard of care treatment (including surgery, radiation and chemotherapy), patients with newly diagnosed GBM have a median survival of only about 14.6 months, and less than 5% of such patients are still alive at 5 years.
"We're excited and encouraged by the continued extension of survival in the patients who received DCVax® in the prior clinical trials," commented Dr. Al Boynton, NWBT's CEO, "especially since DCVax® is non-toxic, unlike chemotherapies, and involves just a simple injection under the skin, like a flu shot."
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 under the skin in the upper arm, 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.
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 240-patient Phase II trial in GBM. The Company also previously 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 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.
SOURCE Northwest Biotherapeutics, Inc.
