BOTHELL, Wash., May 3 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics today announced that the company will be presenting updated data from the second Phase I clinical trial on patients who have received DCVax(R)-Brain, a personalized therapeutic cancer vaccine, at the 12th Annual Meeting of the International Society for Cellular Therapy (ISCT), being held May 4-7, 2006 in Berlin.
Marnix Bosch, PhD, MBA, Vice President of Vaccine Research and Development for Northwest Biotherapeutics, will present updated survival and progression data, accumulated through April 2006, at his presentation on Saturday, May 6th at 5:45 pm. Dr. Bosch will also be available immediately following the presentation to discuss the findings, and the Phase II development of DCVax(R)-Brain as a promising new cancer therapy.
A program to provide booster immunizations to surviving patients in this Phase I trial was recently allowed by the FDA, and initiated at UCLA. Dr. Bosch commented on the booster vaccine program: “The booster immunizations are expected to further enhance the protective anti-tumor immune response in these surviving patients. We hope that this program will allow continued lengthening of survival times.”
The Phase I clinical trial of DCVax(R)-Brain involved patients with Glioblastoma multiforme (GBM) one of the deadliest forms of brain cancer. GBM has median times to progression and death of approximately 8 and 15 months, respectively. Primary therapy for GBM, involving surgery followed by radiotherapy and concurrent chemotherapy, creates a low tumor burden environment that can be ideal for immunotherapy approaches. Dendritic cell-based immunotherapy, such as that by Northwest Biotherapeutics in its DCVax(R)-Brain vaccine, uses autologous dendritic cells pulsed with tumor biomarkers (antigens). This therapeutic approach aims at safely stimulating anti-tumor immune responses to prevent tumor recurrence or progression.
As previously reported by the Company, the following findings had been observed and reported for the Phase I clinical trial of DCVax(R)-Brain as of three months ago, in February 2006:
-- 8 of 10 patients still alive, with median survival of 20.5 months and continuing; -- 4 of 10 patients survived over 30 months and were continuing, and 5 of 10 patients survived over 24 months and were continuing; -- 8 of 10 patients surpassed the historical control median survival of 15 months, with other patients still continuing toward that point; -- Survival times to date ranged from 11.2 months to 39.0 months, and continuing; -- 5 of 10 patients continued to show no signs of cancer, with median follow-up time of 32 months; -- Median time to progression (i.e., tumor recurrence) was 14.7 months and continuing; -- 9 of 10 patients had surpassed the historical median time to progression of 8 months.
The findings as of April 15th, 2006 will be announced after this week’s presentation at the ISCT meeting 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 expected to enter a Phase III clinical trial this year; 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, the uncertainty of the clinical trials process 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 of Northwest Biotherapeutics, +1-425-608-3008
Web site: http://www.nwbio.com//
