Large International CRO With Extensive Experience Will Manage European Trial

BETHESDA, Md., Feb. 15, 2013 — Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that, building upon nearly three years
of  manufacturing development, regulatory processes and 
clinical preparations in Europe, the Company has named a leading
international contract research organization (CRO) to manage the
Company’s 312-patient Phase III clinical trial for Glioblastoma
multiforme (GBM) brain cancer in Europe.

The Company’s Phase III trial is well under way in the U.S.,
currently enrolling at 41 sites.  In the U.S., the trial is
being managed by a U.S. CRO that does not have operations in Europe
that can handle this trial.

The Company’s Phase III trial has undergone extensive
preparations and regulatory approvals in Europe.  The trial is
poised to begin enrolling patients in the U.K. later in this
calendar quarter, and elsewhere in Europe in the next several
months.

Engaging a first class CRO was one of the last steps required
for initiating enrollment in the U.K.  After an extensive RFP
process, the Company selected PAREXEL International.  PAREXEL
is a leading international CRO with unparalleled expertise in
managing international clinical trials.  Over the past 30
years, they have developed significant expertise in oncology,
including glioblastoma.  Headquartered near Boston,
Massachusetts, they operate in 71 locations throughout 54 countries
around the world, and have over 14,000 employees.

This engagement to manage NW Bio’s Phase III brain cancer trial
in Europe builds upon the foundations of the Company’s European
programs which have been in development since 2010.  In the
U.K., preparations completed by the Company for the Phase III trial
include regulatory approval by the Medicines and Healthcare
Products Regulatory Agency (MHRA – equivalent to the FDA),
nationwide Ethics Committee approval (equivalent to Institutional
Review Board approvals in the U.S.), selection and qualification of
the first four trial sites (major opinion leader centers),
institutional reviews and approvals at the lead site, Kings College
Hospital, and manufacturing technology transfer and validation in
the U.K.

In Germany, preparations for the Phase III trial completed by
the Company include the establishment of a wholly owned subsidiary
(NW Bio GmbH) with a highly experienced CEO formerly in the senior
management of Schering A.G. for many years, as well as selection of
24 candidate trial sites (including all major opinion leader
centers in brain cancer), half a year of manufacturing technology
transfer followed by a 2-year regulatory process for manufacturing
certification by both the national and local regulators in Germany,
further followed by development of a validated data package
sufficient to support Phase III trial designation, then preparation
and submission of the Phase III clinical trial application package
to the national regulator (the PEI), and initial preparations for
Ethics Committee approvals (equivalent to IRB approvals in the
U.S.) at trial sites.

“Putting in place a CRO of PAREXEL’s caliber is one of the final
building blocks for our Phase III trial in Europe.  After 3
years of extensive preparatory work, this is an important milestone
and a reflection of the exciting potential of this trial” commented
Linda F. Powers, CEO of NW Bio.   “We are fortunate to
have a large number of marquee institutions as partners in Europe,
including the Fraunhofer Institute, Kings College Hospital and
Sarah Canon Research Institute, among others.  PAREXEL’s
international reach and deep experience, including in clinical
trials with GBM brain cancer, will be a great addition to the
team.”

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 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 has also conducted a
Phase I/II trial with DCVax® for metastatic ovarian cancer together
with the University of Pennsylvania. 

Disclaimer

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
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 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.