BETHESDA, Md., June 20, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, today refuted Adam
Feuerstein's latest false headline and attack on the
Company, and reaffirmed the Company's recent interim data
announcements from its Phase I/II clinical trial of DCVax-Direct
for all inoperable solid tumors.
The Company's DCVax-Direct trial is ongoing. Contrary to
Feuerstein's sensationalized false headline, the Company has not
received a "rebuke" from any clinical trial site, nor does the
Company believe there is any basis for any such "rebuke."
The Company has consistently said that it would release interim
data on an ongoing basis during the course of its DCVax-Direct
Phase I/II trial. This trial is a single-arm, unblinded,
"open label" trial, meaning that all of the patients in the trial
are receiving the DCVax-Direct treatment, and the clinical results
in patients are visible to the Company as the trial goes along.
There has been significant interest in this trial, and the
Company has been receiving many requests for data updates, as this
trial is testing a novel treatment for patients with late stage,
inoperable tumors – patients for whom there are virtually no
treatment options today. The data released by the Company
came from the medical files at the clinical trial sites and reviews
of imaging and biopsies, and was provided by the sites and
pathology labs, as well as a respected and independent clinical
research organization (CRO) managing the trial.
Contrary to Feuerstein's assertions of promotional claims by the
Company, in fact the Company has taken extra care to emphasize in
its announcements that the data being reported are only early,
initial and partial results. The Company has expressly
explained in each announcement that the patients are only part way
through the treatment regimen, and the Company specifically
cautioned that the data could get either better or worse as more
data are collected.
Also contrary to Feuerstein's attack, it is neither unusual nor
inappropriate for interim results from unblinded, open label trials
to be reported, particularly in the case of a novel technology in a
particularly difficult disease setting that is the subject of
significant scientific, clinical and public interest. In such
cases, both companies and researchers frequently provide interim
data and/or case studies.
Linda Powers, CEO of NW Bio,
commented: "As NW Bio continues to make strong progress in multiple
programs with two product lines, for both operable and inoperable
tumors, and as NW Bio's clinical programs show encouraging early
effects, Feuerstein seeks ever more sensationalized ways to try to
smear the Company. This is not even the semblance of
professional analysis. We condemn this attack campaign and
appreciate the strong support we are receiving from shareholders,
patients and other commentators. We intend to continue our
progress undeterred."
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 ongoing
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, 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 contemplated in the Cognate Agreements, 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.