BETHESDA, Md., July 16, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that the Phase I portion of the Company's
Phase I/II DCVax-Direct clinical trial has completed its 36-patient
target recruitment, and the Company is now underway with
preparations for the Phase II portion of this trial, as well as
expansion of DCVax-Direct manufacturing.
The Phase I/II trial is testing the safety and activity of
DCVax-Direct in various types of cancer. The Phase I portion of the
trial has involved testing of 3 different dose levels, and a
diverse range of cancers. The patients enrolled in Phase I
will continue to receive treatments in accordance with the
protocol.
With the closing of Phase I, the Company is now preparing to
initiate the Phase II portion of the trial. This second part
of the Phase I/II study will target 24 or more patients in selected
cancers. Additional trial sites are being brought on to
facilitate and expedite enrollment.
The Company and its manufacturing partner, Cognate BioServices,
are also expanding the manufacturing capacity for
DCVax-Direct. During the last two years, in addition to
manufacturing the DCVax-Direct products for the clinical trial,
Cognate has undertaken development work for the DCVax-Direct
program, and the automated system used in certain key stages of
DCVax-Direct production, in order to build the foundation for this
expansion of manufacturing capacity.
"It is very gratifying to reach this important milestone in the
Phase I portion of the Phase I/II DCVax-Direct clinical trial,"
commented Linda Powers, CEO of NW
Bio. "We are looking forward to proceeding with Phase II,
with anticipated expansion of the clinical trial sites and expanded
manufacturing capacity and automation efficiencies."
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, and is an "orphan disease." The Company is
under way with a 60-patient Phase I/II trial with DCVax-Direct for
all inoperable solid tumor cancers. The Company previously
received clearance from the FDA for a 612-patient Phase III trial
in prostate cancer. The Company conducted a Phase I/II trial
with DCVax for metastatic ovarian cancer together with the
University of Pennsylvania. In
Germany, the Company recently received approval of a 5-year
Hospital Exemption for treatment of glioma (brain cancer) patients
outside the clinical trial.
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," "design," "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 risks related to the Company's ability
to enroll patients in its clinical trials and complete the trials
on a timely basis, uncertainties about the clinical trials process,
uncertainties about the timely performance of third parties, risks
related to whether the Company's products will demonstrate safety
and efficacy, risks related to the Company's and Cognate's
abilities to carry out the intended manufacturing expansions, risks
related to the Company's ongoing ability to raise additional
capital, risks related to the Company's ability to carry out the
Hospital Exemption program and risks related to possible
reimbursement and pricing. 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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SOURCE Northwest Biotherapeutics, Inc.