Sponsored by
Experts Guide Development of Promising Personalized Vaccine in Late Stage
Trial for Most Lethal Form of Brain Cancer
BOTHELL, Wash., Sept. 20 /PRNewswire-FirstCall/ -- Northwest
Biotherapeutics (OTC Bulletin Board: NWBT.OB) announced today that a Clinical
Advisory Board (CAB) has been appointed to guide the Company in its late stage
clinical trial for a personalized vaccine treatment for Glioblastoma
multiforme (GBM), the most lethal form of brain cancer. Northwest
Biotherapeutics' vaccine, DCVax(R)-Brain, uses a patient's own dendritic cells
to mobilize the body's full immune system against cancer. DCVax(R)-Brain
showed very promising results in two Phase I clinical trials and a large,
multi-center Phase II clinical trial is planned for this Fall.
Comprised of world-renowned oncologists, neurosurgeons, neurologists and
neuroscientists, the Clinical Advisory Board will play an important role in
guiding the upcoming large Phase II trial. In addition, it is anticipated
that the leading medical centers with which the CAB members are affiliated may
be among the first sites at which enrollment for the Phase II trial will
begin.
"We are proud to have such a distinguished Clinical Advisory Board with
some of the world's most respected and experienced experts in the fields of
brain cancer, neurology, and clinical design, who will work together to
advance our personalized vaccines for the benefit of patients with
Glioblastoma multiforme," said Alton Boynton, Ph.D., President and Chief
Operating Officer of Northwest Biotherapeutics.
Linda Liau, M.D., Ph.D., a neurosurgeon from the University of California
at Los Angeles (UCLA) served as principal investigator for two Phase I
clinical trials of DCVax(R)-Brain in patients with newly diagnosed and
recurrent GBM, and will Chair Northwest Biotherapeutics' Clinical Advisory
Board for DCVax(R)-Brain. "DCVax(R)-Brain has shown outstanding therapeutic
promise in early clinical testing. We have patients living cancer-free and
exceeding standard survival times for GBM, the most aggressive form of brain
cancer. The Clinical Advisory Board is eager to begin its work to advance the
development of DCVax(R)-Brain so that an increasing number of patients will
have access to it as soon as possible."
The Northwest Biotherapeutics Clinical Advisory Board for DCVax(R)-Brain
is comprised of:
Linda Liau, M.D., Ph.D. - Chair
Dr. Liau is Director of the Malignant Brain Tumor Program at the UCLA
School of Medicine, and an Associate Professor of Neurosurgery at the
University of California at Los Angeles (UCLA). Dr. Liau is a well-respected
neurosurgeon and has served as a clinical investigator for trials of
investigational new drugs. She serves on the Editorial Boards of the Journals
of Neuro-Oncology, Neuro-Oncology, and Surgical Neurology. She holds a B.S.
and B.A. from Brown University, an M.D. from Stanford and a Ph.D. in Molecular
Neuroscience from UCLA.
Darell D. Bigner, M.D., Ph.D.
Dr. Bigner serves as the Edwin L. Jones, Jr. and Lucille Finch Jones
Cancer Research Professor of Pathology, and Professor of Surgery at the Duke
Comprehensive Cancer Center, Duke University Medical Center. He is also Chief
of the Division of Experimental Pathology Research and Vice Chair of Research
in the Department of Surgery. Dr. Bigner's main area of research is the
causes, mechanisms of transformation and altered growth control and new
therapy for primary and metastatic tumors of the central nervous system. Dr.
Bigner holds a B.S. from the University of Georgia, and an M.D. and Ph.D. from
Duke University.
Henry Brem, M.D.
Dr. Henry Brem is the Director of the Department of Neurosurgery, Harvey
Cushing Professor of Neurosurgery, Professor of Ophthalmology, and Oncology
for The Johns Hopkins Hospital. He is also Director of the Hunterian
Neurosurgical Research Laboratory at Johns Hopkins. His practice specializes
in the surgical treatment of pituitary tumors, meningiomas, skull base tumors,
and other solid brain tumors. He has developed new clinical treatments for
brain tumors including the local delivery of chemotherapeutic agents in
biodegradable polymers, Gliadel wafer, for which a patent was issued and a
product approved by the FDA. Dr. Brem received his A.B. from New York
University, and M.D. from Harvard Medical School.
Tom Mikkelsen, M.D.
Dr. Mikkelsen serves in the Eugene & Marcia Applebaum Lab of Molecular
Therapeutics and is Co-Director, Hermelin Brain Tumor Center, Josephine Ford
Cancer Center, at the Henry Ford Hospital Detroit, Michigan. Dr. Mikkelsen is
also Staff Neuro-Oncologist, Division of Neurology, Department of Medicine,
for the William Beaumont Cancer Center, in Royal Oak, Michigan. Dr. Mikkelsen
received his B.S. degree from the University of Alberta and his M.D. from the
University of Calgary.
Steven S. Brem, M.D.
Dr. Brem is Chief of the Neurosurgery Service, Director, Neuro-Oncology
research laboratory, and Division Chief, Neuro-Oncology, for the H. Lee
Moffitt Cancer Center & Research Institute of the University of South Florida.
Dr. Brem also serves as a New Approaches to Brain Tumor Therapy (NABTT)
Investigator. His research interests include frameless image-guided surgery,
surgery of brain metastasis and malignant tumors, experimental therapeutics,
anti-angiogenesis therapies, pituitary surgery and skull base surgery. Dr.
Brem received a B.A. from Rutgers University and an M.D. from Harvard Medical
School.
About Glioblastoma Multiforme
Brain cancer is diagnosed in approximately 200,000 patients per year, of
which approximately 20,000 are primary tumors that arise within the brain and
are not metastatic lesions from elsewhere in the body. Approximately 60% of
primary brain cancers are diagnosed as GBM, the most aggressive and lethal
form.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing
immunotherapy products that treat cancers more effectively than current
treatments, without toxicity, on a cost-effective basis. The Company has two
broad platform technologies: dendritic cell based vaccines, and therapeutic
antibodies. The Company's two lead product candidates are:
DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment of
hormone independent non-metastatic prostate cancer, which is entering a Phase
III clinical trial;
DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of
newly diagnosed Glioblastoma multiforme, which is entering a large Phase II
clinical trial.
CXCR4 is a therapeutic monoclonal antibody for treatment of solid tumors,
and is in late pre-clinical development.
Statements made in this news release that are not historical facts are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Words such as "expects," "believes,"
"intends," 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 the Company's ability to raise additional capital, risks
related to the Company's ability to enroll patients in the planned Phase III
trial of DCVax(R)-Prostate and complete the trial on a timely basis, the
uncertainty of the clinical trials process and whether DCVax-Prostate will
demonstrate safety and efficacy, risks associated with the planned Phase II
clinical trial of DCVax(R)-Brain and the planned Phase I clinical trial for
non-small cell lung cancer and head and neck cancer, and the timely
performance of third parties. Additional information on these and other
factors, which could affect the Company's results, is included in its
Securities and Exchange Commission 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 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. Participation by Dr. Brem as a member
of the Clinical Advisory Board does not constitute or imply endorsement by the
Johns Hopkins University or the Johns Hopkins Hospital and Health System.
SOURCE Northwest Biotherapeutics
Web Site: http://www.nwbio.com
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