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Northwest Biotherapeutics Receives Institutional Review Board Approval to Accrue Patients in Phase II Brain Cancer Trial


Posted on: 11/28/2006

 

Northwest Biotherapeutics Receives Institutional Review Board Approval to Accrue Patients in Phase II Brain Cancer Trial


Personalized Cancer Immunotherapy in Phase II Trial in Glioblastoma Multiforme

BOTHELL, Wash., November 28, 2006 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. , a biotechnology company focused on cancer immunotherapy, today announced that it has received Institutional Review Board (IRB) and contractual approval from the Henry Ford Hospital in Detroit, Michigan to proceed with the Company's Phase II trial of its personalized therapeutic cancer vaccine, DCVax(R)-Brain, in patients with newly diagnosed Glioblastoma multiforme ("GBM").


 
"The IRB approval is an important milestone in launching this key trial for patients with newly diagnosed GBM. We are privileged to be working with the Henry Ford Hospital and Tom Mikkelsen, M.D., the study's Principal Investigator at Henry Ford Hospital, and co-director of the Hermelin Brain Tumor Center. We look forward to starting patient accrual at additional clinical sites shortly," stated Alton Boynton, Ph.D., President of Northwest Biotherapeutics.

Dr. Mikkelsen stated, "Given the limited treatment options for these patients, we welcome the efforts of Northwest Biotherapeutics in moving this groundbreaking immunotherapy forward, and we are excited to be the first clinical site in this important trial."

The DCVax(R)-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. The data for these two trials continue to mature. To date, newly diagnosed GBM patients treated with DCVax(R)-Brain have shown a more than doubling of the time to recurrence or progression of the cancer to 18.1 months compared with 8.1 months for institutional control patients (p<0.0001). The DCVax(R)-Brain treated patients have also shown a significant extension of overall survival to 33.8 months compared with 17 months for institutional control patients (p=0.0045).

Data for patients with recurrent GBM are equally impressive. The time to disease recurrence or progression, and the overall survival time, both more than doubled in DCVax(R)-Brain treated patients compared with patients receiving standard of care.

DCVax(R)-Brain uses a patient's own tumor, surgically removed as part of 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 cell responsible for starting and managing the body's overall immune response), and injected back into the patient through a simple intra-dermal injection at various intervals over a three year period. The DCVax(R)-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(R)-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(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; DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has entered into a large Phase II clinical trial 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 enroll patients in the planned Phase II clinical trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the clinical trials process 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.

CONTACT: Lorie Calvo, +1-425-608-3008, for NWBT

Web site: http://www.nwbio.com//

Ticker Symbol: (NASDAQ-OTCBB:NWBT)

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