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Dendritic Cell attacking cancer cells - Picture csa.com nwbio.com nwbio.com nature.com Dendritic cell (DC)-mediated activation of natural killer (NK) cells can affect their ability to lyse tumours (through perforin-dependent mechanisms) or can reduce the growth and metastatic capacity of tumours (through interferon- (IFN-)-dependent mechanisms). Interactions between NK cells and tumour cells, which involve both NK-cell activating and inhibitory receptors, are essential. NK cells that have interacted with tumour targets can secrete cytokines that affect the maturation of DCs, so they might participate in the generation and/or maintenance of tumour-specific T-cell-mediated responses. In addition, antigens that are generated in the process of tumour killing by activated NK cells can provide DCs with increased access to tumour antigens. Tumours that secrete certain proteins, such as the heat-shock protein (HSP) glycoprotein 96 (gp96), are rejected by cytotoxic T lymphocyte (CTL)-mediated antitumour responses, the generation of which relies on the presence of NK cells. IL, interleukin; NKG2D, NK group 2, member D; RAE1, retinoic acid early transcript 1. nature.com What are Dendritic cells? Immunotherapy with dendritic cells for cancer. Ballestrero A, Boy D, Moran E, Cirmena G, Brossart P, Nencioni A. Department of Internal Medicine, University of Genoa, 16132 Genoa, Italy. Dendritic cells are professional antigen-presenting cells with a key role in both immunity induction and tolerance maintenance. Dendritic cells are highly specialized in antigen capture, processing and presentation, and express co-stimulation signals which activate T lymphocytes and NK cells. Dendritic cells generated in culture and loaded with an antigen efficiently induce antigen-specific immunity after injection. More recently, methods have been developed that target antigens to dendritic cells in vivo, bypassing the need for ex vivo cell manipulations. Numerous ongoing studies aim to evaluate the effectiveness of dendritic cell vaccines in preventing tumor relapses and extending patients' survival. Further implementation of this form of immunotherapy is expected following the identification of the mechanisms controlling dendritic cell immunogenicity, and from a better understanding of the cell dynamics whereby immune responses are orchestrated. Here, we discuss these new insights together with an overview of the dendritic cell-based clinical studies carried out to date. ncbi.nlm.nih.gov Home Page - Northwest Biotherapeutics nwbio.com DCVAX nwbio.com Phase 2 DCVAX Clinical Trial Detail Glioblastoma Multiforme Drug: Dendritic cell immunotherapy Phase II ClinicalTrials.gov Identifier: NCT00045968 clinicaltrials.gov Yahoo finance.yahoo.com 12/27/2007 New Phase 1 Ovarian Cancer Trial - guessing - not being funded by Northwest Message 24163443 12/20/2007 Patent infringement claims against Northwest withdrawn By Andrea K. Walker Sun reporter baltimoresun.com 11:45 AM EST, December 20, 2007 Message 24152412 10/18/2007 Clinical Trial Evaluating Brain Cancer Vaccine is Underway at NYU A clinical trial evaluating a brain cancer vaccine in patients with newly diagnosed brain cancer has begun at NYU Medical Center. The study will evaluate the addition of the vaccine following standard therapy with surgery and chemotherapy in patients with glioblastoma multiforme, a deadly form of brain cancer med.nyu.edu 12/20/2007 Clinical Trial Sites Study of a Drug [DCVax®-Brain] to Treat Newly Diagnosed GBM Brain Cancer Los Angeles, UCLA Medical Center Emma Young Phone: 310-267-2621 E-mail: elyoung@mednet.ucla.edu Detroit, Henry Ford Health System Ruth Ann Baesse Phone: 313-916-3731 E-mail: rbeasse1@HFHS.org New Jersey Overlook Hospital Pat Eagan Phone: 908-522-5914 E-mail: pat.eagan@atlantichealth.org New York, NYU Jennifer Brown Phone: 212-263-5810 E-mail: jennifer.brown@nyumc.org nwbio.com 2/14/2007 First DCVAX patients in Phase 2 Trial for newly diagnosed Glioblastoma multiforme (GBM) SEVERE EDIT The DCVax(R)-Brain treatment consists of three initial immunizations at 2 week intervals, followed by four booster injections at 2- and 4-month intervals for the remainder of year one, and thereafter semi-annual maintenance injections for an additional two years. DCVax(R)-Brain showed no toxicity in previous studies in over 100 patients. The DCVax(R)-Brain Phase II clinical trial is based on two Phase I studies carried out at UCLA under the direction of Linda Liau, M.D., Ph.D., Director of the Malignant Brain Tumor Program at the UCLA School of Medicine. Each of the trials included both newly diagnosed (early stage) GBM, and recurrent (late stage) GBM. DCVax(R)-Brain has doubled the time to progression and the overall survival time in both the early and the late stage patients. The data for those trials continue to mature. hirntumorhilfe.de 2002 - Technology evaluation: DCVax, Northwest Biotherapeutics Knutson KL. University of Washington, Tumor Vaccine Group, Seattle 98195, USA. kknutson@u.washington.edu DCVax, a dendritic cell-based immunotherapy, is an active immunization platform being developed by Northwest Biotherapeutics for the potential treatment of multiple malignancies, including hormone-refractory metastatic prostate cancer, non-small-cell lung cancer, renal cancer and glioblastoma multiforme. The DCVax platform is tailored to a specific cancer type with either purified tumor-specific antigen or tumor cell extracts derived from patients at the time of resection. Phase I/II clinical trials of DCVax-Prostate have been completed, and phase III clinical trials have recently been initiated. DCVax-Brain is currently undergoing phase II clinical trials, and DCVax-Lung recently received approval from the US FDA for phase I clinical trials. PMID: 12222879 [PubMed - indexed for MEDLINE] ncbi.nlm.nih.gov SEC Filings sec.gov SEC Form S1 Common stock outstanding on December 5, 2007: 42,346,088 shares sec.gov 3RD Quarter 10Q - Sept 30, 2007 SEVERE EDIT In February 2007, we, through our legal representative, applied to the Bundesamt für Gesundheit (“BAG” or “Office Fédéral de la Santé Publique”) in Switzerland for an Authorization for Use (“Autorisation”). In June 2007, we, through our legal representative, received such Autorisation from the BAG to make DCVax®-Brain available at limited selected medical centers in Switzerland as well as an authorization (“Autorisation pour activités transfrontalières avec des transplants”) to export patients’ cells and tissues from Switzerland, for vaccine manufacturing in the USA, and to import patients’ DCVax®-Brain finished vaccines into Switzerland. These authorizations are conditional upon certain implementation commitments which must be fulfilled to the satisfaction of Swissmedic (“Institut Suisse des Agents Thérapeutiques”) before the product may be made available (e.g., finalizing our pending arrangements for a clean-room suite for processing of patients’ immune cells). Implementation of these commitments is underway. In the BAG’s processing of and decision on our application and data with respect to the authorizations described above, Swissmedic conducted an inspection of our facilities. A comprehensive evaluation of DCVax®-Brain will be conducted by Swissmedic within the assessment of a Marketing Authorization Application (“MAA”). We plan to submit for Marketing Authorization Application by the end of this year. The assessment by Swissmedic of our MAA will include a full review by Swissmedic of the safety and efficacy data generated in our DCVax®-Brain clinical studies to date. This review could take up to one year from the date the MAA is submitted. If Marketing Authorization is granted for DCVax®-Brain by Swissmedic we would have the right to fully market and commercialise the product in Switzerland. However, if and until such a Market Authorization is granted, and assuming the Company completes its implementation committments to the satisfaction of Swissmedic, DCVax®-Brain may only be made available at the selected Medical Centers in Switzerland under the Autorisation granted, by the BAG. The term of the BAG Autorisation is five years from June 2007. We are also conducting a DCVax-Brain® Phase II pivotal trial in 141 patients in the U.S. Presently we have four clinical sites with open enrollment. We plan to seek product approval in both the US and EU in 2009, based upon the results of the pivotal trial. DCVax®-Brain has been granted orphan drug status in both the U.S. and the European Union. Such status will afford DCVax®-Brain 7 years of market exclusivity in the U.S. and 10 years in the European Union, if DCVax®-Brain is the first product of its type to reach product approval. sec.gov SEVERE EDIT Glioblastoma multiforme Data from the first Phase I clinical trial at UCLA demonstrated that patient survival was more than twice as long for patients receiving DCVax®-Brain treatment than for patients receiving either of the two currently FDA-approved therapies. Data from the second Phase I clinical trial, which began in November 2002, continue to mature and as of August 8th, 2006, the findings appear to be even more striking than the data from the first Phase I trial. For example: -- 6 of 10 patients are still alive, with median survival not yet reached; -- 5 of these 6 patients continue to be cancer-free, with no recurrence and with median follow-up time of 37 months; -- Survival times in this trial now range up to 44.4 months (and continuing). Further, details about this ongoing, long-term follow-up data from the second Phase I trial will be presented by NWBT later this month biz.yahoo.com | ||||||||||||||
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