BOTHELL, Wash., Feb. 13 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBT.OB
), a biotechnology company focused on cancer immunotherapy, today announced that the first two patients in its pivotal Phase II clinical trial have undergone surgery for newly diagnosed Glioblastoma multiforme (GBM), which is the first step in the preparation of the Company's DCVax®-Brain treatment. The surgeries took place at Henry Ford Hospital in Detroit, MI.
"We are very pleased to begin the patient accrual process for this Phase II trial, and anticipate completing enrollment in Q4 of this year. We are also working with nine other clinical sites to accelerate patient accrual during the next few months," stated Alton Boynton, President of Northwest Biotherapeutics. Dr. Boynton further stated, "I consider this a major milestone for NWBT and look forward to rapid patient accrual in this important clinical trial."
The DCVax®-Brain treatment 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 thereafter semi-annual maintenance injections for an additional two years. DCVax®-Brain showed no toxicity in previous studies in over 100 patients.
The DCVax®-Brain Phase II clinical trial is based on two Phase I studies carried out at UCLA under the direction of Linda Liau, M.D., Ph.D., Director of the Malignant Brain Tumor Program at the UCLA School of Medicine. Each of the trials included both newly diagnosed (early stage) GBM, and recurrent (late stage) GBM. DCVax®-Brain has doubled the time to progression and the overall survival time in both the early and the late stage patients. The data for those trials continue to mature.
In the newly diagnosed GBM patients, DCVax®-Brain has increased the time to recurrence or progression of disease as described in Kaplan Meier plots from 8.1 months with standard of care treatments to 18.1 months with DCVax®- Brain (p< 0.00001). Kaplan Meier plots also showed that DCVax®-Brain increased median overall survival from 17 months with standard of care treatments to 33.8 months (p=0.0044) for DCVax®-Brain treated patients. Ten of the 19 patients remain alive for periods ranging to date from 10 to 80 months. Similarly, in recurrent (late stage) patients, DCVax®-Brain has increased median survival from 6.4 months for historical controls receiving standard of care to 13.2 months for patients receiving DCVax®-Brain.
DCVax®-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 into the patient's own dendritic cells (the master cells responsible for starting and managing the body's overall immune response), and injected back into the patient through a simple intra-dermal injection, similar to an insulin shot, at various intervals over a three year period. The DCVax®-Brain Phase II trial is designed and powered as a pivotal trial, and 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®-Brain. A sufficient quantity of each patient's personal therapeutic cancer vaccine is prepared in a single manufacturing procedure to provide for 3 years of treatment.
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®-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®-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 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 enroll patients in its Phase II clinical trial of DCVax®-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®-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.