BETHESDA, Md., March 12, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, today refuted false statements and material distortions
made by Adam Feuerstein in an
article on Tuesday, March 11.
Feuerstein falsely accused NW Bio of manipulating its news by
delaying announcement of the Hospital Exemption approval by the
Paul Ehrlich Institute ("PEI," the FDA of Germany). Feuerstein's accusations were
factually wrong, materially misleading and reflect a lack of
knowledge on Feuerstein's part in regard to the German procedures
and legal requirements relating to the PEI decision and the
Company's announcement.
Feuerstein noted that the PEI decision was delivered to the
Company on Friday, February 21. What Feuerstein failed to
note was that the quite lengthy PEI decision document was delivered
to the Company entirely in German. Due to the length
and technical nature of the document, it required more than a week
for the Company to receive the English translation. The
Company then had to obtain confirmation of the accuracy of the
translation, and obtained confirmations about certain provisions of
the approval. This process took several days.
Finally, under the applicable German regulations, before the
Company was permitted to issue its announcement, the Company was
legally required to obtain approval of the full text of the
Company's announcement by an Information Officer in Germany who had been designated as required by
the PEI. The approval of the independent German Information
Officer was provided to the Company at the end of the day German
time, mid-day U.S time, on Friday, March 7. The Company then
proceeded with issuance of the announcement on Monday morning,
March 10.
The only manipulation that has occurred in this case is
Feuerstein's use of the date of just the first step in the
multi-step process to distort the facts about NW Bio's announcement
and its timing.
Feuerstein's article also raised assorted additional speculative
and misleading claims relating to the Company's clinical trial
program. The Company reiterates that its Phase III trial is
on track, and it refutes those Feuerstein claims as well.
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.
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.
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SOURCE Northwest Biotherapeutics, Inc.