NORTHWEST BIOTH (OTC:NWBT)
Industry: Healthcare
Northwest Biotherapeutics, Inc. (Northwest Biotherapeutics), incorporated in July 1998, is a development stage biotechnology company that focuses on discovering, developing and commercializing immunotherapy products that safely generate and enhance immune system responses to effectively treat cancer. The Company's approach in developing cancer therapies utilizes its expertise in the biology of dendritic cells, which are a type of white blood cells that activate the immune system. Northwest Biotherapeutic has two basic technology platforms applicable to cancer therapeutics: dendritic cell-based cancer vaccines, which it calls DCVax, and monoclonal antibodies for cancer therapeutics. The DCVax dendritic cell-based cancer vaccine program is the Company's main technology platform. The DCVax platform combines the Company's expertise in dendritic cell biology, immunology and antigen discovery with its process of producing and activating dendritic cells outside a patient's body to develop therapeutic products that stimulate beneficial immune responses to treat cancer. DCVax product candidates are designed to elicit a natural immune response. Pre-clinical and clinical trials have demonstrated that DCVax product candidates can train a patient's own Killer T cells to seek and destroy specifically targeted cancer cells. The Company's therapeutic antibody platform is based on combining its expertise in monoclonal antibodies, immunology and antigen discovery with potential collaborators who have expertise in humanized and fully human monoclonal antibody development. Northwest Biotherapeutics develops its therapeutic antibody products candidate in the following sequence: identification, immunization, selection and culturing, analysis and evaluation, humanization and manufacturing. DCVax Product Candidates DCVax-Prostate, the Company's initial dendritic cell-based product candidate, resulted from combining the DCVax platform with the cancer-associated antigen prostate specific membrane antigen, or PSMA. Prostate specific membrane antigen is located on the surface of prostate cells. It is expressed at very low levels on benign or healthy prostate cells, and at much higher levels on prostate cancer cells. Because PSMA is over-expressed in virtually all prostate cancers, it represents an effective target for prostate cancer therapeutics. The results from the Phase I/II clinical trial provided Northwest Biotherapeutics with important results supporting the potential value of the DCVax platform as the basis for new cancer immunotherapies. In September 1999, Northwest Biotherapeutics filed an application to conduct a Phase I/II clinical trial for DCVax-Prostate to treat late-stage prostate cancer patients for whom hormone therapy was no longer effective. Initial DCVax-Prostate Phase I/II clinical trial has shown mild injection site reactions, which were typical and fully anticipated, but no significant adverse side effects in over 110 clinically administered injections. Northwest Biotherapeutics submitted an investigational new drug application (IND) with the United States Food and Drug Administration (FDA) on December 8, 2004, for restarting its Phase III clinical trial for prostate cancer, DCVax-Prostate. The IND cleared the FDA on January 8, 2005. This Phase III clinical trial is based on promising clinical data from a previously conducted Phase I/II clinical trial. That double blinded, placebo controlled Phase III clinical trial was planned for 600 patients at 30-50 sites throughout the United States, however, the Company is considering other trial designs that may enable it to reduce the number of patients required. In any case, the trial will focus on non-metastatic hormone-independent prostate cancer patients. DCVax-Brain uses the DCVax platform in combination with glioblastoma tumor cell lysate antigens. The Company's clinical collaborators at the University of California at Los Angeles (UCLA) conducted two Phase I clinical trials to assess the safety and efficacy of dendritic cell-based immunotherapy for glioblast
As Of: 10/07 00:00 ET
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