Northwest Biotherapeutics Adds UCLA As A Site For Its Pivotal Phase II Brain Cancer Trial

Main Category: Neurology / Neuroscience
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials;  Immune System / Vaccines
Article Date: 08 Mar 2007 - 0:00 PDT

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Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBT.OB), a biotechnology company focused on cancer immunotherapy, today announced that The University of California at Los Angeles (UCLA) has been added as a clinical site in its ongoing pivotal Phase II trial for DCVax(R)-Brain for patients with newly diagnosed Glioblastoma multiforme (GBM). The first UCLA surgery was performed by Dr. Linda Liau, M.D., Ph.D., the principal investigator of the clinical trial, and the Director of the Malignant Brain Tumor Program at the UCLA School of Medicine. The UCLA program is one of the leading brain cancer centers in the U.S., treating hundreds of such cases per year. The first UCLA surgery follows recent surgeries in this Phase II trial at Henry Ford Hospital. Nine other clinical trial sites are pending.

Dr. Liau stated, "This is a very significant event for patients at UCLA who are diagnosed with GBM. We are excited to work with Northwest Biotherapeutics on this registration trial, and work with the other clinical centers around the country to complete enrollment in as short a time frame as possible."

"We are very pleased to add UCLA as a clinical site, and to have Dr. Liau lead this effort as the principal investigator for this pivotal trial," stated Alton Boynton, President of Northwest Biotherapeutics. "Dr. Liau is a noted expert in the brain cancer field, and is playing a major role in the pioneering of novel treatments for GBM patients."

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 year two and year three.

The DCVax(R)-Brain Phase II clinical 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. DCVax(R)-Brain has more than doubled the time to disease progression (recurrence), and doubled the overall survival time, in both the early and the late stage patients. The data for those trials continue to mature, as a majority of the patients are still alive.

NWBT's vaccines have shown no toxicity in studies in over 100 patients. 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 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(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 to provide for 3 years of treatment is prepared in a single manufacturing procedure, making DCVax(R)-Brain a very cost effective 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)-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 pivotal 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 five other cancers beyond brain and prostate 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(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.
http://www.nwbio.com