BETHESDA, Md., May 29, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, refuted the latest blatantly false and misleading
statements made by Adam Feuerstein,
in an article on Tuesday, May 27.
Feuerstein's headline: "Cancer Patients Aren't Responding
to Northwest Bio's DCVax-Direct."
Feuerstein's claim: "None of the 19 patients with
advanced, metastatic cancers have responded to treatment with
DCVax-Direct in an ongoing Phase I clinical trial."
Actual facts: While still only part way through
treatment, more than 50% of these patients (11 of the 19) have
already shown tumor shrinkage of up to 28%, substantial tumor cell
death and substantial accumulation of immune cells in the
tumors. These data were shown in imaging scans and biopsies
provided by the world-renowned cancer centers conducting this
clinical trial, as the Company made clear in its announcement and
conference call.
Feuerstein claim: "Under the globally accepted definition
of tumor response known as RECIST (Response Evaluation Criteria in
Solid Tumors), a partial response requires a 30% reduction in the
size of the target lesion."
Feuerstein claim: "DCVax-Direct: 0% response
rate."
Actual facts: There are numerous types of
established measures of patient responses to treatments.
The measures reported in the Company's announcement (partial
tumor shrinkage, substantial tumor cell death and substantial
accumulation of immune cells in the tumors) are considered
clinically significant and are regularly the focus of peer reviewed
scientific and medical publications in oncology, particularly for
late stage disease which is the focus of the Company's DCVax-Direct
trial.
The RECIST criteria are just one set of measures, and the
Company has made no claims about these measures. Further, the
RECIST criteria themselves include multiple categories: they
recognize not only a "Partial Response" of 30% or more -- they also
recognize "Stable Disease" (which includes tumor shrinkage of up to
28% as has been seen among the early responses in the Company's
DCVax-Direct trial).
"Feuerstein's so-called 'analyses' consist of false statements,
serious misrepresentations and personal attacks and smears,"
commented Linda Powers, CEO of NW
Bio. "Feuerstein's 'analyses' are contradicted by the
concrete data from world renowned cancer centers, and by the
validations NW Bio continues to achieve from regulators in both the
US and Europe, key opinion
leaders, healthcare system institutions, grant agencies and
others. Feuerstein's commentaries seem designed to try to
prevent investors from seeing the strength and progress in NW
Bio."
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 tumors cancers, with a primary efficacy
endpoint of tumor regression. 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 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.
www.nwbio.com
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SOURCE Northwest Biotherapeutics, Inc.