BETHESDA, Md., Jan. 8, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S.
biotechnology company developing DCVax® personalized immune
therapies for solid tumor cancers, today issued the following
statement addressing the sharp decline in the Company's stock:
Global markets are experiencing serious concerns, many biotech
companies' stocks have fallen dramatically, and NW Bio believes
that its stock is being heavily impacted by these serious adverse
market conditions. NW Bio is not aware of any fundamental
Company-related reason for the substantial decline in the price of
the Company's stock at this time.
The most recent data from NW Bio's clinical programs, which was
presented at scientific conferences in London and New
York in mid-September, was encouraging. The Company
raised significant capital in Q4 2015, and is looking forward to
being able to initiate its Phase 2 clinical trials with
DCVax-Direct.
The Company's September 2015
update included encouraging ongoing interim survival data from both
the Phase I trial of DCVax-Direct in 13 diverse cancers, and the
Information Arm of 51 patients who were unable to enroll in the
Phase III trial of DCVax-L for newly diagnosed Glioblastoma
multiforme (GBM) brain cancer because of apparent early tumor
recurrence.
In the DCVax-Direct trial for patients with multiple inoperable
metastatic tumors who had failed standard treatments (including
multiple different chemotherapy regimens), half of these patients
were still alive with survival times ranging up to 22 months,
exceeding expected survival times.
In the DCVax-L Information Arm, for the 25 GBM patients with
apparent early tumor recurrence at one of two time points, 40% of
the patients had reached or exceeded approximately 3 years'
survival. This substantially exceeded the expected survival
time of about 15 months even for regular GBM patients without early
tumor recurrence.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on
developing personalized immunotherapy products designed 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 348-patient Phase III trial in newly
diagnosed Glioblastoma multiforme (GBM), which is on a partial
clinical hold in regard to new screening of patients. 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 types of inoperable solid
tumors cancers. It has completed enrollment in the Phase I
portion of the trial. The Company previously conducted a Phase
I/II trial with DCVax-L for metastatic ovarian cancer together with
the University of Pennsylvania.
The Company previously received clearance from the FDA for a
612-patient Phase III trial in prostate cancer. In
Germany, the Company has received
approval of a 5-year Hospital Exemption for the treatment of all
gliomas (primary brain cancers) 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 and
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.