BOTHELL, Wash., Oct. 30 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics updated survival and progression data on patients from two clinical trials carried out at The University of California at Los Angeles (UCLA). The patients were treated with DCVax(R)-Brain, a personalized cancer immunotherapy, for Glioblastoma multiforme (GBM). The report was given today at 8:30 a.m. at the C.E. Unterberg, Towbin Life Sciences Conference today in New York City, and at the Annual Meeting of the International Society of Biological Therapy for Cancer held in Los Angeles on October 26-28.
A landmark analysis of disease progression at two years showed that 44% of DCVax(R)-Brain treated GBM patients were progression-free (with no return of their cancer), while only 11% of historical control patients were progression-free at two years (n=278, Stupp et. al., N. Eng. J. Med., 352: 987, 2005): a 4-fold improvement (p<0.005). Overall survival at two years also showed a significant treatment effect: 68% of DCVax(R)-Brain treated patients were still alive, compared with only 26% of historical control patients: a 2.6-fold improvement (p<0.001).
Kaplan Meier analysis showed that the median times, both for disease progression (recurrence) and for survival, were dramatically better in DCVax(R)-Brain treated patients than in historical control patients from UCLA. (The UCLA historical controls, n=119, were limited to patients in similar prognostic groups as 18 newly diagnosed GBM patients in the Phase I clinical trials. The Stupp data, n=278, are more representative of the population of GBM patients in general. The UCLA data thus set a higher standard for comparison with DCVax(R)-Brain treatment than do the data from the full GBM patient population). The analysis indicates that in the 18 newly diagnosed GBM patients, those treated with DCVax(R)-Brain had a median progression free survival (time to recurrence of disease) of 18.1 months compared to 8.1 months for historical controls from UCLA. (p<0.0001; hazard ratio=0.27). Kaplan Meier plots revealed that the median survival for DCVax(R)-Brain treated patients is 33.8 months, to date, compared to 17 months for historical controls from UCLA. (p<0.0052; hazard ratio=0.4).
Dr. Linda Liau, M.D., Ph.D. and principal investigator for these two Phase I trials at UCLA stated, “We are thrilled with the long-term survival of these patients, and 9 of the 18 are still alive with survival times ranging between 10 and 77 months. These patients recently started to receive DCVax(R)-Brain booster injections. We are also very anxious to begin enrolling patients in our pending randomized Phase II clinical trial sponsored by Northwest Biotherapeutics.”
As of October 1, 2006 the following additional findings had been observed and reported for the GBM patients with newly diagnosed disease in two Phase I clinical trials of DCVax(R)-Brain:
*9 of 18 patients are alive; *16 of 18 patients surpassed the median time to progression (progression free survival) of 6.9 months in historical control patients (Stupp et al.); *14 of 16 patients have so far surpassed the median survival time of 14.6 months in historical control patients (Stupp et al.), and 2 patients entered later in the study have so far survived 10 months post treatment without progression; *Most patients in whom immune response could be measured showed a significant increase in antigen-specific CD8+ T cells.
The GBM patients with late stage (recurrent) disease in the two trials have so far shown similarly encouraging results: median progression free survival (time to recurrence of disease) of 8.2 months in DCVax(R)-Brain treated patients compared with 2.9 months in historical controls, and median overall survival of 12.2 months in DCVax(R)-Brain treated patients compared with 6.4 months in historical controls.
Dr. Alton Boynton, President of Northwest Biotherapeutics stated, “We continue to be very encouraged with the observed clinical benefits of DCVax(R)-Brain. The company continues to make progress towards enrolling the first patients in this pending pivotal Phase II clinical trial, and we expect to begin enrolling patients next month.”
About DCVax-Brain
DCVax(R)-Brain is an immunotherapy that uses personalized (autologous) dendritic cells (immune cells) loaded with a patient’s own tumor biomarkers (antigens). This therapeutic approach safely stimulates anti-tumor immune responses to help prevent tumor recurrence or progression. Primary therapy for GBM, which includes surgery followed by radiotherapy and concurrent chemotherapy, creates a low tumor burden environment that can be favorable for immunotherapy approaches.
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 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 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, Inc.
CONTACT: media, Lorie Calvo of Northwest Biotherapeutics, Inc.,+1-425-608-3008
Web site: http://nwbio.com/
