BOTHELL, Wash., May 23 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics today released updated Phase I survival and progression data on patients who have received DCVax(R)-Brain, a therapeutic personalized cancer vaccine.
The Phase I clinical trial of DCVax(R)-Brain involved patients with Glioblastoma multiforme (GBM), the deadliest form of brain cancer. Dendritic cell-based immunotherapy, such as that by Northwest Biotherapeutics in its DCVax(R)-Brain vaccine, uses autologous dendritic cells that are pulsed with tumor antigens. This therapeutic approach aims at safely stimulating anti-tumor immune responses to prevent tumor recurrence or progression.
As of May 15th, 2006, the following findings had been observed and reported for the Phase I clinical trial of DCVax(R)-Brain:
-- 6 of 10 patients are still alive, with median survival of over 22.1 months (and continuing); -- Survival time ranges from 13.5 to 41.9 months (and continuing); -- 5 of 10 patients continue to show no signs of cancer recurrence, with median follow-up time of 34.8 months; -- To date, median time to progression (i.e., tumor recurrence) is over 14.9 months (and continuing); -- 9 of 10 patients have surpassed the historical median time to progression of 8 months; -- 4 of 10 patients have survived over 30 months, and there are three patients alive with range in survival from 14.2 to 21.1 months; and -- 8 of 10 patients to date have surpassed the historical control median survival of 15 months, with one patient at 14.2 months approaching the 15-month point.
Without such treatment, GBM has historical median times to progression and death of approximately 8 and 15 months, respectively. Primary therapy for GBM, which includes surgery followed by radiotherapy and concurrent chemotherapy, creates a low tumor burden environment that could be ideal for immunotherapy approaches. These patients are enrolled in a booster program and will continue to receive injections of DCVax-Brain over the next year.
Recent data from this trial was presented May 6th, 2006 at the 12th Annual Meeting of the International Society for Cellular Therapy in Berlin.
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 III trial of DCVax(R)-Prostate and complete the trial on a timely basis, the uncertainty of the clinical trials process and whether DCVax(R)-Prostate will demonstrate safety and efficacy, risks associated with the planned Phase II clinical trial of DCVax(R)-Brain and the planned Phase I clinical trial for non-small cell lung cancer and head and neck cancer, 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
CONTACT: Lorie Calvo, +1-425-608-3008
Web site: http://www.nwbio.com//
