BOTHELL, Wash., April 17 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. , today announced that it has filed for Authorization for Use of its DCVax(R)-Brain therapeutic vaccine in Switzerland to treat patients with malignant brain cancers, including Glioblastoma multiforme (GBM), the most aggressive and lethal form of brain cancer. If approved, Northwest Biotherapeutics will be authorized to commercialize, market and import/export DCVax(R)-Brain for the treatment of patients at selected centers in Switzerland. The application, submitted to the Swiss Institute of Public Health or Bundesamt fur Gesundheit (BAG), will be reviewed by the BAG and Swissmedic. Northwest Biotherapeutics expects to receive a decision from the BAG during Q3 of this year.
“We are excited to achieve a major milestone of our corporate strategy, and to have the possibility of bringing one of the first personalized therapies to market on a highly cost-effective basis. We are also excited to potentially bring an important new treatment to patients suffering from one of the most aggressive cancers, for which little can be done today” stated Alton Boynton, President of Northwest Biotherapeutics. “We look forward to preparing for the commercial use of DCVax(R)-Brain at leading medical centers in Switzerland later this year, and soon afterwards in other countries. Switzerland is an attractive place to begin commercialization, due to its highly respected regulatory oversight, and its growing experience with cellular therapies. Switzerland is also increasingly noted for medical tourism.”
The incidence of newly diagnosed primary brain cancers in Europe is approximately 50,000 per year, with about 20,000 of these being GBM. The incidence of such newly diagnosed primary brain cancers in the US is approximately 40,000 per year, with about 13,000 being GBM.
Data from two Phase I clinical trials on DCVax(R)-Brain carried out at UCLA continue to mature: the delays in disease progression and the extensions of overall survival continue to grow longer as DCVax(R)-Brain treated patients continue to survive. To date, the clinical data have shown a median survival of 33.8 months (and continuing) for DCVax(R)-Brain treated patients, with 10 of 19 patients still alive from 8-82 months after initial surgery. Most of these patients have no evidence of tumor recurrence. Four of these patients have survival times without progression or recurrence of their cancer that now extends beyond 45 months.
These data are statistically very significant compared to standard of care treatment, and compared to matched controls from UCLA. The delay in disease progression or recurrence now shows a p value of 0.00001. The extension of overall survival now shows a p value of 0.0015.
The Company is currently enrolling patients in the US in a DCVax(R)-Brain Phase II clinical trial designed and powered as a pivotal trial. This Phase II trial is based on two Phase I studies carried out at UCLA under the direction of Dr. Linda Liau. Each of the trials included both newly diagnosed (early stage) and recurrent (late stage) GBM patients. The DCVax(R)-Brain Phase II trial will involve 141 patients. All patients will receive full standard of care treatment, which includes surgery, radiation and chemotherapy, and approximately 94 of these patients will also receive DCVax(R)-Brain.
A sufficient quantity of each patient’s personal therapeutic cancer vaccine to provide for 3 years of treatment is prepared in a single manufacturing procedure, making DCVax(R)-Brain very cost effective compared with current cancer drugs. The overall DCVax(R)-Brain treatment regimen consists of three initial immunizations at 2-week intervals, followed by four booster injections at 2- and 4-month intervals for the remainder of year one, and then semi-annual maintenance injections in years two and three.
Northwest Biotherapeutics’ vaccines have shown no toxicity (no grade 3 or grade 4 toxicity) in the two Phase I DCVax(R)-Brain clinical trials. Patients who receive DCVax(R)-Brain develop only redness and itching at the injection site no debilitating side effects.
DCVax(R)-Brain uses a patient’s own tumor, surgically removed as part of the standard of care, to prepare a mix of their personal cancer biomarkers. These personal cancer biomarkers are then loaded, through a proprietary process, into the patient’s own dendritic cells (the master cells responsible for starting and managing the body’s overall immune response), which have been obtained from the patient’s blood and matured through proprietary processes -- a total production time of only 10 days . After six weeks of radiation and chemotherapy post surgery, the activated dendritic cells are injected back into the patient through a simple intra-dermal injection, similar to an insulin shot, at various intervals over a three year period.
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)-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has entered into a large Phase II pivotal clinical trial cleared by the FDA; -- DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which is ready to enter a Phase III clinical trial cleared by the FDA; and -- Monoclonal antibodies to CXCR4, which are in late pre-clinical development for the treatment of multiple cancers. For further information, please visit the company web site at http://www.nwbio.com.
The Company also has a robust pipeline of additional products cleared by FDA for early stage clinical trials in multiple other cancers.
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 obtain approval to use DCVax(R)-Brain in Switzerland, the company’s ability to enroll patients in its Phase II clinical trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the clinical trials process, the timely performance of third parties, 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, Inc.
CONTACT: Lorie Calvo of Northwest Biotherapeutics, Inc., +1-425-608-3008
Web site: http://www.nwbio.com/
