BOTHELL, Wash., Feb. 22 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. today released updated findings from a Phase I clinical trial of the personalized cancer vaccine, DCVax(R)-Brain, showing that patients are surviving more than twice as long with DCVax(R)-Brain as with either of the two therapeutics currently approved by the FDA for Glioblastoma multiforme (GBM), the most aggressive form of brain cancer. Based upon these findings, FDA allowance has been received and Northwest Biotherapeutics has entered into an agreement with the University of California at Los Angeles (UCLA) to begin providing booster shots to clinical trial participants. Dr. Linda Liau, Associate Professor of Neurosurgery and Director of the Malignant Brain Tumor Program at the UCLA School of Medicine, served as Principal Investigator for the trial.
Patients in the trial were newly diagnosed with GBM, which affects between 18,000 and 20,000 Americans each year. Beyond surgery to remove the brain tumor and radiation therapy, there are only two treatments for GBM currently approved by the FDA. Those treatments have been shown in clinical trials to extend survival in GBM patients by only 2-3 months. In contrast, in the ongoing DCVax(R)-Brain Phase I clinical trial at UCLA, patients have experienced much longer extensions of survival, and longer periods before tumor recurrence.
Data from an earlier clinical trial at UCLA demonstrated that patient survival was more than twice as long for patients receiving DCVax(R)-Brain treatment than for patients receiving either of the two currently FDA-approved therapies. For the current clinical trial, as of February 1st, 2006, the findings appear to be even more significant:
-- 8 of 10 patients are still alive, with median survival of 20.5 months (and continuing); -- Survival time now ranges from 11.2 months to 39.0 months (and continuing); -- 5 of 10 patients continue to show no signs of cancer, with median follow-up time of 32 months; -- To date, median time to progression (i.e., tumor recurrence) is 14.7 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 5 of 10 patients have survived over 24 months; and -- 8 of 10 patients to date have surpassed the historical control median survival of 15 months.
“Findings such as these, where we are seeing over half of our patients with GBM alive after two years, and 4 of 10 patients alive after two and one-half years, with other patients still continuing toward the two-year and two and one-half year marks, present a unique opportunity for us to make a significant difference in the lives of these patients,” stated Dr. Alton L. Boynton, President and Chief Operating Officer of Northwest Biotherapeutics. “We believe that the results to date are particularly striking as the patients only received an initial series of injections and no booster shots. Now, with the FDA allowance and the agreement with UCLA, each patient will be able to receive up to five booster shots over the next 12 months. It is our hope that these booster injections will further enhance and sustain the patient’s immune response in attacking the cancer and preventing or delaying its recurrence.”
The DCVax(R)-Brain personalized vaccine in clinical development is a type of immunotherapy designed to stimulate a patient’s own immune system to fight cancer. DCVax(R)-Brain is a simple injection made up of the patient’s own dendritic cells that have been “educated” to recognize and kill cancer cells bearing the biomarkers of the patient’s tumor. Dr. Boynton explained, “Each of these patients has undergone tumor removal at surgery as part of the current standard of care. We use some of those tumor cells, and the dendritic cells drawn from a sample of the patient’s blood, to teach the immune system to recognize the tumor cells as harmful so the body can work to eradicate them.”
Northwest Biotherapeutics has received funding since 2004 from Toucan Capital Fund II, L.P. and Toucan Partners LLC for company operations and to financially support the booster vaccines to participants in this clinical trial. The Company plans to initiate a large Phase II clinical trial of DCVax(R)-Brain that is powered to serve as a pivotal trial in support of potential product registration. The trial has already been cleared by the U.S. FDA, and is expected to enroll 300 patients nationwide.
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 recently cleared by the FDA ; DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of newly diagnosed Glioblastoma multiforme, which is entering a large Phase II clinical trial recently cleared by the FDA; and monoclonal antibodies to CXCR4, which are 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 initiate, and enroll patients in, the planned Phase II trial of DCVax(R)-Brain and complete the trial on a timely basis, risks related to the Company’s ability to initiate, and 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 or DCVax(R)-Brain will demonstrate safety and efficacy, risks associated with 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, Inc.
CONTACT: Mary P. Sundeen, +1-301-775-0240, for Northwest Biotherapeutics,Inc.
Web site: http://www.nwbio.com//
