Vaccins en effect bij hersentumoren: Vaccin DCVax(R)-Brain welke succesvol blijkt tegen hersentumoren - Glioblastoma nu officieel verkrijgbaar in Zwitserland. Adressen van ziekenhuizen waar trial loopt toegevoegd. Update artikel 5 mei 2011
10 mei 2011: er loopt in Amerika een grote fase III trial met DCvax, een vorm van dendritische celtherapie, waarvoor nog steeds patienten worden gevraagd. Mocht u daar aan willen deelnemen neem dan contact op met een van de onderstaande adressen. Doe dit het liefst in samenwerking met uw oncoloog of neuroloog, omdat ik denk dat u dan de meeste kans maakt aangenomen te worden.
28 februari 2008: update over lopende trial en vaccin DCVax (R)-brain.
Vandaag ontvingen we een persbericht over de lopende trial met het vaccin DCVax (R) - Brain. Het bljikt dat van de 19 patienten die meedoen aan een tweede fase i/II trial er nog 18 in leven zijn en de meesten al ruimschoots de mediane overlevingstijd hebben gepasseerd. Dit is toch wel heel interessant lijkt ons. Hier het volledige persbericht gekopieerd van Musella@virtualtrials.com UCLA vraagt overigens patienten om mee te doen aan een grootopgezette fase II/III studie. In Zwitserland is dit vaccin al officieel verkrijgbaar als behandelingsmiddel.
BETHESDA, Md., Feb. 20 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO; AIM: NWBT and NWBS) ("NWBT" or the "Company") today announced the most recent long-term follow-up data, as of year-end 2007, on disease progression and overall survival in patients taking part in its Phase I and Phase I/II clinical trials for newly diagnosed patients with Glioblastoma multiforme ("GBM"), the most aggressive form of brain cancer. The additional data covers the period from April 2007 through year-end 2007. During this time, none of the patients experienced disease progression (recurrence) and only one patient died (at 36.4 months). Thus, the data show that in the 19 clinical trial patients receiving DCVax(R)-Brain in addition to Standard of Care, both the median overall survival and the median time to disease progression (recurrence) are more than twice as long as in patients receiving the Standard of Care for GBM. Dr. Linda Liau, Associate Professor of Neurosurgery and Director of the Malignant Brain Tumor Program at the UCLA School of Medicine ("UCLA"), served as the Principal Investigator for the trial.
Since 2005, the Standard of Care for patients with GBM is surgery followed by a combination of radiation and daily Temodar(R) chemotherapy, and then 6 monthly cycles of Temodar chemotherapy. The studies defining this Standard of Care achieved a median time to progression of 6.9 months and a median overall survival of 14.6 months (Stupp, et. al., N Engl J Med, 352:987, 2005). Further data from UCLA have demonstrated a somewhat longer median time to progression of 8.1 months and median overall survival of 17.0 months in patients with GBM who received Standard of Care.
The year-end 2007 data obtained by the Company concerning the 19 patients from the two trials at UCLA with newly diagnosed GBM continue to be positive, with no patients progressing and only one patient dying (at 36.4 months). Overall, the long-term follow-up data are now as follows:
o 8 of 19 patients are still alive (ranging from 24.5 months to 92 months), with median overall survival in all patients of 33.8 months (p < 0.0079) (the "p value" measures the likelihood that the observed clinical effect is due to chance: a 'p' value of 0.0079 means that there is a less than 1% possibility that the longer survival time of DCVax(R)-Brain-treated patients is due to chance); o 5 of the 8 patients who are still alive show no signs of cancer recurrence, with follow-up time ranging from 41 months to 92 months; o The median time to progression (i.e. tumor recurrence) is 18.1 months, compared to 8.1 months for patients treated at UCLA during the same time period (p = 0.00001); o 90% of patients have surpassed the Standard of Care median time to progression of 8.1 months; o 84% of patients have surpassed the Standard of Care median overall survival time of 17.0 months; o To date, 68% of patients receiving DCVax(R)-Brain in addition to Standard of Care have lived longer than 2 years, 42% have lived longer than 3 years, and 26% have lived longer than 4 years (48, 54, 57, 62 and 92 months so far);
"Findings such as these, where we are seeing 68% of our DCVax(R)-Brain-treated patients with GBM alive after two years, and 26% alive for more than 4 years (and counting) reinforce our belief that DCVax(R)-Brain may make a significant difference in the lives of patients with GBM," stated Dr. Alton L. Boynton, President and Chief Executive Officer of Northwest Biotherapeutics. "We believe that the results to date are particularly striking, and we plan to give patients continued booster injections at 3 month intervals. We believe that these booster injections will further enhance and sustain the patient's immune response in attacking the cancer and preventing or delaying its recurrence."
GBM, the most aggressive form of brain cancer, is estimated to have caused over 12,000 deaths in the US in 2007; and brain cancer is estimated to have caused over 39,000 deaths in Europe in 2002 (in each case the last year for which estimates are available). Beyond surgery to remove the brain tumor, and radiation therapy, there are only two treatments for GBM currently approved by the Food and Drug Administration ("FDA"). Those treatments have been shown in clinical trials to add only 10-12 weeks of survival in GBM patients. In contrast, in the two clinical trials conducted at UCLA with DCVax(R)-Brain, the patients have experienced much longer extensions of the time to disease progression (recurrence) and overall survival.
DCVax(R)-Brain is a type of personalized immunotherapy designed to stimulate a patient's own immune system to fight cancer. DCVax(R)-Brain is made up of the patient's own dendritic cells that have been "educated" to recognize and destroy cancer cells bearing the biomarkers of the patient's tumor. Each patient undergoes tumor removal through surgery as part of the current Standard of Care. Dendritic cells drawn from a sample of the patient's blood are exposed in a lab dish to the biomarkers of the patient's own tumor, and are thereby activated and "educated." These activated and "educated" dendritic cells are injected back into the patient, in a simple small injection under the skin similar to a flu shot or insulin shot, at a series of time points several weeks apart and then months apart. These dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicity to the patient (i.e., without grade 3 or 4 adverse events)
The Company has initiated a large Phase II clinical trial of DCVax(R)-Brain that is designed and powered to serve as a pivotal trial in support of potential product registration. The trial is currently screening and enrolling patients at a number of sites across the U.S.
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 is currently conducting a large Phase II clinical trial in GBM, which is designed and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has started, and is currently enrolling patients in, a Phase I/II trial with DCVax(R) for recurrent ovarian cancer. The Company's second technology platform, involving antibodies to CXCR4, is at the late pre-clinical development stage.
For further information, please visit the company web site at http://www.nwbio.com/
16 juli 2007: bron: Musella
Het vaccin DCVax(R)-Brain is door de Zwitserse autoriteiten goedgekeurd om te gebruiken als medicijn bij hersentumoren - glioblastoma. DCVax (R)-brain is een vorm van dendritische celtherapie waarbij gebruik gemaakt wordt van eigen kankercellen om het vaccin te maken. Dit vaccin blijkt het eerste vaccin tegen hersentumoren te zijn dat nu officieel beschikbaar is en gebruikt mag worden. Trials zouden hebben uitgewezen dat dit vaccin de overleving van glioblastoma patienten bijna verdubbeld. Maar ik kan in Pubmed weinig tot geen studies vinden die dit zouden bewijzen. Het enige wat ik kan vinden is een lopende fase II trial.
DCVax-Brain and DC vaccines in the treatment of GBM.
Source
Maxine Dunitz Neurosurgical Institute, Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
Abstract
BACKGROUND:
DCVax-Brain (Northwest Biotherapeutics, Inc., Bethesda, MD, USA) is a personalized treatment for brain tumors. Its approach of administering autologous tumor antigen-bearing dendritic cells (DCs) has garnered hope for more effective and less toxic therapy for patients with malignant brain tumors including glioblastoma multiforme (GBM). DCVax-Brain composition and efficacy are not fully disclosed, although sponsors claim it is poised to critically test clinical DC vaccine efficacy in GBM patients.
OBJECTIVE:
This review examines the efficacy of DC vaccine therapy in treating GBM patients. REVIEW QUESTION: To determine if the approach of DC vaccination followed by DCVax-Brain shows ample clinical promise in GBM patients.
SEARCH STRATEGY:
All published reports of DC vaccination for GBM and press releases regarding DCVax-Brain findings were evaluated. CRITICAL APPRAISAL OF REPORTS AND SUMMARY OF OUTCOMES: Published DC vaccine trials for high-grade glioma patients suggest favorable clinical outcomes not easily ascribed to non-treatment parameters. Evidence of possible selection bias exists in many reports, but efforts to account for this are evident in the most recent publications.
CONCLUSION:
DC vaccine trials provide evidence of low toxicity in GBM patients and effective induction of antitumor immunity in the latest publications correlate with clinical improvements. Preliminary reports on DCVax-Brain clinical outcomes seem to follow these trends.
Adressen waar studies lopen met DCVax voor hersentumoren
DCVax®-L for Newly Diagnosed Brain Cancer
» Clinical Sites:
Los Angeles, UCLA Medical Center
Linda Liau, MD
Phone: 310-267-2621
E-mail: lliau@mednet.ucla.edu
Detroit, Henry Ford Health System
Tom Mikkelsen, MD
Phone: 313-916-8641
E-mail: nstom@neuro.hfh.edu
New Jersey, Overlook Hospital
Michael L. Gruber, MD
Phone: 908-522-5914
E-mail: michael.gruber@nyumc.org
New York, NYU Cancer Institute
Michael L. Gruber, MD
Phone: 212-731-5577
E-mail: michael.gruber@nyumc.org
University of Cincinnati
Margie Gerena-Lewis, MD
Phone: 513-584-6178
E-mail: lewism2@ucmail.uc.edu
University of Illinois at Chicago
John Villano, MD
Phone: 312-996-6768
E-mail: jvillano@uic.edu
Virginia Piper Cancer Institute
John Trusheim, MD
Phone: 612-262-4837
E-mail: Nilanjana.banerji@allina.com
University of Michigan
Jason Heth, MD
Phone: 734-615-4486
E-mail: jheth@umich.edu
University of Hospitals of Cleveland
Andrew E. Sloan, MD
Phone: 216-844-6054
E-mail: andrew.sloan@uhhospitals.org
Baylor Research Institute
Karen Fink, MD, PhD
Phone: 214-820-8690
E-mail: karenfin@baylorhealth.edu
Moffitt Cancer Center
Steven Brem, MD
Phone: 813-979-3063
E-mail: brem@moffitt.usf.edu
University of Rochester
Kevin A. Walter, MD
Phone: 585-276-3581
E-mail: Kevin_Walter@URMC.Rochester.Edu
