BETHESDA, Md., Jan. 25, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, today announced that it is expanding its Board of
Directors through the appointment of Ms. Susan Bayh and Ambassador Cofer Black as independent Directors.
Neither Ms. Bayh nor Ambassador Black has worked with the
Company previously.
Ms. Bayh brings to NW Bio 25 years of experience relating to the
pharmaceutical and biotech industries, including in immunotherapies
for cancer. She has served on the Boards of Wellpoint, Inc.,
a Fortune 30 health insurance company with the Blue Cross brand in
fifteen states, as well as on the board of eight public biotech
companies, and three other companies, including in multiple
leadership positions. Several of these biotech companies have
been successfully acquired. She also served as in-house
counsel at a major pharma company for five years, handling FDA
pre-approval and post-approval matters.
Through these Board and corporate roles, Ms. Bayh gained
extensive experience with corporate governance and regulatory
compliance, as well as a broad spectrum of business matters,
including fundraising, corporate partnering, clinical trial
requirements and execution, regulatory requirements relating to
product approvals, orphan drugs, certification of manufacturing
facilities, product marketing and commercialization, and product
pricing and reimbursement.
Ms. Bayh also brings specific experience in regard to
personalized immunotherapies for cancer, as she served for a number
of years on the Board of Dendreon, a biotech company that was an
early pioneer in developing such therapies and the first company to
obtain FDA approval for such a product. Ms. Bayh gained
first-hand experience in regard to the challenges and pitfalls that
can be involved in obtaining regulatory approval and reimbursement,
and in commercializing such immunotherapies, as well as insights
into potential improvements and solutions. Ms. Bayh's
experience on the Dendreon Board has also prepared her well for
dealing with the special challenges facing biotech
companies.
Susan Bayh commented that "It is
exciting to see the potential of DCVax, with encouraging clinical
data to date, an excellent safety profile, a fast and efficient
manufacturing process and a finished product that is frozen… key
factors for commercialization potential. I've seen it all, in
terms of the challenges with personalized immune therapies… what
works and what doesn't. I look forward to applying the
lessons of my experience to help bring the DCVax technology to
patients."
Ambassador Black is internationally recognized in the
intelligence community and brings to NW Bio extensive experience in
cybersecurity, counterintelligence, and investigations and related
matters. Ambassador Black served a 28-year career in the CIA,
including as Director of the Counterterrorist Center managing 1,300
professionals and an annual budget in excess of $1 billion. In that capacity, he served as
the focal point for the intelligence community, supervised the
Interagency Counterterrorism Board, was responsible for CIA
all-source analysis, directed all CIA counterterrorism operations
abroad, including covert action, and defined global intelligence
strategy for the U.S. Ambassador Black was awarded the
Distinguished Intelligence Medal (the CIA's highest award for
achievement) as well as numerous other awards.
Subsequently, in the private sector, from 2009 to the present
Ambassador Black has served as Vice President for Global Operations
at Raytheon Blackbird, advising the U.S. Government on security
matters and equipment. He also serves as a Senior Advisor to
the Razor's Edge Investment Fund, focusing on cutting edge
technologies and equipment for the intelligence communities.
Ambassador Black commented: "It is exciting to see the potential
of the DCVax personalized immune therapies being developed by NW
Bio for a wide range of cancers. I look forward to utilizing
my expertise in helping the Company protect its technology and
operations."
Linda Powers, CEO of NW Bio,
stated that "We are excited to have received the necessary
approvals and to have two such high caliber professionals as Ms.
Bayh and Ambassador Black join our Board. They bring
extensive expertise in two different areas of major importance and
value for NW Bio as we expand and strengthen our organization and
we work to accelerate our progress."
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 Phase I/II trial
with DCVax-Direct for all types of inoperable solid tumor
cancers. Phase I has been completed: 40 patients were
enrolled, and 13 different cancers were treated. Phase II is
upcoming. 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