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Northwest Biotherapeutics Adds UCLA as a Site to Its Pivotal Phase II Brain Cancer Trial

Posted on: 03/09/2007

Northwest Biotherapeutics Adds UCLA as a Site to Its Pivotal Phase II Brain Cancer Trial
                    First UCLA Patient Surgery Performed
    BOTHELL, Wash., March 7 /PRNewswire-FirstCall/ -- 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
    *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 .
    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.
SOURCE Northwest Biotherapeutics, Inc.

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