BOTHELL, Wash., Aug. 28 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics updated its Phase I survival and progression data on patients from two clinical trials who have received DCVax(R)-Brain, a therapeutic personalized cancer vaccine. The report was given at the Cambridge Healthtech Institute’s 3rd Annual Cancer Immunotherapeutics and Vaccines Conference in Boston, MA on August 23, 2006.
As of August 15, 2006, the ongoing findings from the two Phase I clinical trials for DCVax(R)-Brain were as follows:
-- 7 of 16 patients are still alive, with follow-up times ranging from 18 to 75 months; -- 6 of these 7 patients have shown no cancer recurrence; -- in a landmark analysis at 24 months, 63% of treated patients were alive while in historical controls 26% of patients were alive (p < 0.001); -- 14 of 16 patients surpassed the historical control median survival of 15 months.
With existing treatments, GBM has historical median times to progression and death of only about 8 and 15 months, respectively. Adding immunotherapy treatment with NWBT’s DCVax(R)-Brain has greatly extended those times in both Phase I trials. DCVax(R)-Brain is a personalized dendritic cell-based immunotherapy, made from a patient’s own dendritic cells and a patient’s own tumor biomarkers (antigens). Patients from these Phase I trials will continue to receive booster injections of DCVax(R)-Brain over the next year.
Dr. Alton Boynton, President of Northwest Biotherapeutics stated, “Based on these data, patients treated with DCVax(R)-Brain can expect to live longer, healthier lives, despite being diagnosed with the most lethal form of brain cancer. Extending survival for the majority of patients for over two years is certainly unprecedented in this disease. We are eager to begin enrollment in our Phase II clinical trial at the beginning of fourth quarter 2006.”
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’s three lead product candidates are: DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which is entering a Phase III clinical trial; DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of newly diagnosed Glioblastoma multiforme, which is entering a large Phase II clinical trial; and CXCR4 a therapeutic monoclonal antibody in late preclinical development for the treatment of cancer. For further information, please visit the company web site at www.nwbio.com.
Statements made in this news release that are not historical facts 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 the planned Phase II clinical trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the clinical trials process and whether DCVax(R)-Brain will demonstrate safety and efficacy and the timely performance of third parties. Additional information on these and other 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 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.
Northwest Biotherapeutics
CONTACT: Lorie Calvo, +1-425-608-3008, for Northwest Biotherapeutics
Web site: http://www.nwbio.com/
