Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBT.OB) today announced that it
has received FDA clearance to proceed with Phase I clinical testing of its
personalized therapeutic cancer vaccine, DCVax(R)-LB, in non-small cell
lung cancer. The clinical endpoints of the trial will be progression-free
survival (i.e., delay in progression of the cancer) and overall survival.
DCVax(R)-LB is an extension of the promising DCVax(R) personalized
cancer vaccine that has already shown significant delay in disease
progression and in extension of survival in clinical trials in two other
cancers: Glioblastoma multiforme (primary brain cancer) and prostate
cancer. DCVax(R) is a therapeutic vaccine, which is used to treat patients
who already have cancer. DCVax(R) is a personalized treatment: it is made
from a patient's own dendritic cells that have been "educated" to teach the
immune system to recognize and kill cancer cells bearing the biomarkers of
the patient's tumor.
"The same DCVax(R) platform can be used for the treatment of many
different tumor types, since it incorporates all of the biomarkers from the
patient's tumor," stated Dr. Alton Boynton, President of Northwest
Biotherapeutics. "DCVax(R)-LB offers several key advantages over existing
FDA-approved treatments. To date, DCVax(R) product candidates have shown no
toxicity, and have been compatible with other standard therapeutic
regimens, including chemotherapy and radiotherapy. In addition, clinical
data on delay in disease progression and extension of survival in brain and
prostate cancer to date are remarkable."
Lung cancer deaths in the US alone are over 160,000 per year as
compared to 30,350 deaths per year for prostate cancer. Existing treatments
for non-small cell lung cancer include surgery and radiation therapy, which
are used in various combinations. These treatments have significant adverse
side effects, and have had little effect on survival. Likewise,
chemotherapies used in lung cancer have been highly toxic and have had
little effect on survival. In its most recent study, the National
Institutes of Health reported that the five-year survival rate for
non-small cell lung cancer patients was only 6.2% during 1989-1996.
Following initial treatment, virtually all cases of this cancer recur, with
a life expectancy of only about one year following recurrence. No effective
therapy exists for these patients today.
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
entering a Phase III clinical trial recently cleared by the FDA;
DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of
newly diagnosed Glioblastoma multiforme, which is entering a large Phase II
clinical trial recently 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
nwbio.
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 initiate, and enroll
patients in, the planned Phase II trial of DCVax(R)-Brain and complete the
trial on a timely basis, risks related to the company's ability to
initiate, and enroll patients in, the planned Phase III trial of
DCVax(R)-Prostate and complete the trial on a timely basis, the uncertainty
of the clinical trials process and whether DCVax(R)-Prostate or
DCVax(R)-Brain will demonstrate safety and efficacy, risks associated with
the planned Phase I clinical trial for non-small cell lung cancer and head
and neck cancer, 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
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