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.
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.
SOURCE Northwest Biotherapeutics