NW Bio Initiates Phase III DCVax®-L Brain Cancer Trial In Europe: King’s College Hospital In The UK Is First Site To Open

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Up To 30 European Sites To Join 46 Active Sites In The US

BETHESDA, Md., May 16, 2013 — Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax®-L personalized immune therapies for solid tumor
cancers, today announced that its Phase III clinical trial with
DCVax®-L for brain cancer has been initiated at King’s College
Hospital in the UK.

This is one of the first late-stage clinical trials in Europe
with active immune therapies, and its opening is the culmination of
years of planning, development and regulatory and institutional
approvals.  King’s College Hospital, a major center for
neuro-oncology, is leading the way for the many other European
sites.  Three other sites in the UK are also preparing to
open, and nearly 20 sites in Germany are in various stages of
preparation.  In addition, medical centers in other European
countries have requested to be added to the trial. 

This Phase III trial is for newly diagnosed Glioblastoma
multiforme (GBM), the most common and most lethal form of brain
cancer. The trial is already well under way in the US, with 46
active sites at present, and is expected to enroll an aggregate
total of 312 patients in the US and Europe.  Notably, there
are few competing brain cancer trials in Europe, although Europe
has a population larger than the US.

DCVax-L mobilizes a cancer patient’s whole immune system to
attack the full set of biomarker targets on the tumor. 
Current standard of care for GBM brain cancer includes surgical
removal of the tumor, followed by six weeks of daily radiation to
the brain and daily chemotherapy, followed by monthly
chemotherapy.  With all of these treatments, GBM tumors
typically recur within about 6.9 months, and the patients typically
live for about 14.6 months.  In prior Phase I/II clinical
trials, in patients treated with DCVax-L the tumors typically did
not recur for 2 years, and the patients typically lived for 3
years.  A substantial percentage of patents lived even longer,
and to date two patients have exceeded 10 years.  In addition,
DCVax-L is non-toxic and is anticipated to cost less than other
recent cancer drugs.

Dr. Keyoumars Ashkan, Consultant Neurosurgeon [specialist] and
Lead for Neuro-Oncology at King’s College Hospital said: “We are
pleased to be leading the way in bringing these novel immune
therapies to patients in the UK. Brain cancers are some of the most
lethal cancers, and there is a great need for new and better

“The positive data from the clinical trials in the US were very
encouraging in delaying disease progression and extending survival
times, without significant toxic side effects. We are hopeful that
similar results will be seen in the large, randomized clinical
trial which we have now launched in the UK.”

“This is an important landmark, as we begin patient recruitment
in our pioneering Phase III trial of DCVax-L for brain cancer in
Europe, the largest medical market in the world after the US,”
commented Linda Powers, CEO of NW Bio.  “This is one of the
first late-stage clinical trials with active immune therapies in
Europe, and is bringing patients a much needed new treatment
option.  We are excited to be launching this trial with King’s
College Hospital, one of Europe’s premier opinion-leader

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on
developing immunotherapy products to treat cancers more effectively
than current treatments, without toxicities of the kind associated
with chemotherapies, and on a cost-effective basis, in both the
United States and Europe.  The Company has a broad platform
technology for DCVax dendritic cell-based vaccines.  The
Company’s lead program is a 312-patient Phase III trial in newly
diagnosed Glioblastoma multiforme (GBM).  GBM is the most
aggressive and lethal form of brain cancer.  The Company also
previously received clearance from the FDA for a 612-patient Phase
III trial in prostate cancer, and clearance from the FDA for Phase
I/II trials in multiple other cancers.  The Company also
conducted a Phase I/II trial with DCVax for metastatic ovarian
cancer together with the University of Pennsylvania.

About King’s College Hospital

King’s College Hospital NHS Foundation Trust is one of the UK’s
largest and busiest teaching hospitals, with more than 7,000 staff
providing around 1,000,000 patient contacts a year.  King’s
has a unique profile, with a full range of local hospital services
for people in the London boroughs of Lambeth and Southwark as well
as specialist services to patients from further afield.  The
Trust is recognized internationally for its work in liver disease
and transplantation, neurosciences, cardiac, haemato-oncology,
stroke and major trauma.  King’s also plays a key role in the
training and education of medical, nursing and dental students with
its academic partner, King’s College London.  For more
information, visit www.kch.nhs.uk. You can also support the work of
King’s College Hospital at


Statements made in this news release that are not historical
facts, including statements concerning future treatment of patients
using DCVax and future clinical trials, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995.  Words such as “expect,” “believe,”
“intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and
similar expressions are intended to identify forward-looking
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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 clinical trials and
complete the trials on a timely basis, the uncertainty of the
clinical trials process, uncertainties about the timely performance
of third parties, and whether the Company’s products will
demonstrate safety and efficacy.  Additional information on
these and other factors, including Risk 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 from
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.

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