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Northwest Biotherapeutics Announces Clinical Advisory Board for Brain Cancer Program


Posted on: 09/21/2005

Northwest Biotherapeutics Announces Clinical Advisory Board for Brain Cancer Program

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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