martes, 4 de octubre de 2011

First Patients Undergo Surgery In Northwest Biotherapeutics' Phase II Brain Cancer Trial

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(R)-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(R)-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(R)-Brain showed
no toxicity in previous studies in over 100 patients.



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. Each of the trials included both newly diagnosed (early stage)
GBM, and recurrent (late stage) GBM. DCVax(R)-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(R)-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(R)- Brain (p< 0.00001). Kaplan Meier plots also showed that
DCVax(R)-Brain increased median overall survival from 17 months with
standard of care treatments to 33.8 months (p=0.0044) for DCVax(R)-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(R)-Brain has increased median survival from 6.4 months for
historical controls receiving standard of care to 13.2 months for patients
receiving DCVax(R)-Brain.



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 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)-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 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 nwbio/.



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(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.

nwbio/

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