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Thread: DC Vax Trials Now Enrolling at 4 Sites Nationwide (US)

  1. #1

    DCVax Brain Trial Now Enrolling at 25 Sites Nationwide (US)

    clinicaltrials.gov/ct2/show/NCT00045968

    The four recruiting centers are located in New York (University of Rochester), Ohio (University Hospitals of Cleveland), Michigan (Henry Ford Health System) and Minnesota (Virginia Piper Cancer Institute at Abbott Northwestern Hospital).

    Another eight medical centers, spread over multiple other states across the country, have been making preparations for additional enrollment in the ongoing GBM trial. At least four of these eight additional sites are expected to begin or resume recruiting and screening for such enrollment during this calendar quarter.

    To date, 33 patients have already been enrolled in this ongoing 240-patient GBM brain cancer trial and its information arm, and have been proceeding through the treatment regimen and follow-up.

    In prior clinical trials of DCVax® immune therapy for GBM brain cancer, the results were striking: the patients who received DCVax® showed a median survival of 3 years, compared with median survival of only 14.6 months with standard of care today (surgery, radiation and chemotherapy). In addition, the patients treated with DCVax® did not have their tumor recur for approximately 2 years, on average, as compared with tumor recurrence in just 7 months with standard of care today. Moreover, the patients treated with DCVax® did not experience any toxic side effects, in stark contrast to chemotherapies.

    About Northwest Biotherapeutics

    Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for dendritic cell-based vaccines. The Company's lead clinical trial is a 240-patient Phase II trial in newly diagnosed Glioblastoma multiforme ("GBM"), the most aggressive and lethal of brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has also conducted a Phase I/II trial with DCVax® for recurrent metastatic ovarian cancer.

    For further information about clinical sites and about the Company, please visit the Company's web site at:

    Northwest Biotherapeutics is a proud sponsor of Miles for Hope.
    Last edited by NW Biotherapeutics; 01-09-2012 at 06:14 PM. Reason: Links deleted per forum posting policies.

  2. #2
    Northwest Biotherapeutics today announced the addition of 2 new clinical sites to it's expanding clinical trial for Glioblastoma multiforme (GBM).

    The Company previously announced 4 clinical sites for new enrollment into the ongoing trial, located in Rochester, Cleveland, Detroit and Minneapolis. The Company has now added New York City (NYU) and Los Angeles (UCLA). In addition, the Company is nearing completion on 4 further sites, in New Jersey, Michigan, Texas and Washington. As a result, the Company expects to have a total of 10 clinical trial sites for new enrollment into its GBM brain cancer trial within this calendar quarter. This will substantially exceed the Company's projections in regard to the expansion of the clinical trial this quarter. At least 5 further clinical sites are anticipated to be added in the third quarter of this year, resulting in a total of 15 sites.
    Last edited by NW Biotherapeutics; 08-04-2011 at 01:39 PM.

  3. #3

    NWBT Announces Further Expansion of Clinical Sites in Ongoing Brain Cancer Trial

    Northwest Biotherapeutics (OTC.BB:NWBO.ob - News) today announced that it has expanded its number of clinical trial sites, and now has 12 sites across the U.S. open and active, where patients can enroll in the Company’s ongoing clinical trial of DCVax® immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. The Company also announced that a substantial number of additional sites are in process. With the 12 sites already open and active, and others in process, the Company is on track to fulfill its prior projection that it will have 15 sites open and active in Q3 of this year.

    The Company has been receiving growing interest from both physicians and patients around the country. One key basis for the interest has been the positive data from the Company’s prior clinical trials. In prior trials of DCVax® immune therapy for GBM brain cancer, the results were striking: the patients who received DCVax® showed a median survival of 3 years, compared with median survival of only 14.6 months with standard of care today (surgery, radiation and chemotherapy). In addition, the patients treated with DCVax® did not have recurrence of their tumor for approximately 2 years, on average, as compared with tumor recurrence in just 7 months with standard of care today. Moreover, the patients treated with DCVax® did not experience any toxic side effects, in stark contrast to chemotherapies.

    Another key reason for the growing interest in NWBT’s clinical trial relates to the trial design. NWBT’s trial is designed so that it satisfies the regulatory requirements to have a “treated” group and a “placebo control” group, with patients assigned on a randomized basis, and the results in the two groups compared. But NWBT’s trial is also carefully designed so that it goes beyond that, and provides an opportunity for all of the placebo control group patients to “cross over” and receive the DCVax® immune therapy, too, after a certain clinical point has been reached. Other clinical trials of other immune therapies currently under way are not offering this opportunity. In those trials, the patients assigned to the “placebo control” group are required to stay in that group, and are not allowed to receive the immune therapy at all. Physicians and patients are starting to become aware of this important difference in the design of NWBT’s clinical trial versus other clinical trials, and this is attracting increasing interest in NWBT’s trial.

    Dr. Greg Foltz at Swedish Medical Center in Seattle, a newly added site in the NWBT trial, commented that “We are excited to be able to offer patients access to this promising new approach to treating brain cancer. DCVax holds great promise to improve outcomes by stimulating the patient’s own anti-tumor immune response while not disrupting their current standard of care treatments. Another advantage is a trial design that allows all patients to have the opportunity to receive the vaccine during the course of the study. It is refreshing to see a company design a trial which puts the patient’s interests first.”

    The sites at which NWBT’s clinical trial of DCVax® immune therapy for Glioblastoma brain cancer is open and active include the following:

    UCLA in Los Angeles, CA (Dr. Linda Liau)
    University Hospitals Seidman Cancer Center in Cleveland, OH (Dr. Andrew Sloan)
    Virginia Piper Cancer Center in Minneapolis, MN (Dr. John Trusheim)
    Swedish Neuroscience Institute, Seattle, WA (Dr. Greg Foltz)
    NYU in New York, NY (Dr. Michael Gruber)
    Overlook Hospital in Summit, NJ (Dr. Michael Gruber)
    Baylor Research Institute in Dallas, TX (Dr. Karen Fink)
    University of Rochester Medical Center in Rochester, NY (Dr. Kevin Walter)
    Henry Ford Hospital in Detroit, Michigan (Dr. Tom Mikkelson)
    Brain & Spine Surgeons of NY in White Plains, NY (Dr. John Abrahams)
    Sutter Medical Center in Sacramento, CA (Dr. Nora Wu)
    Long Island Brain Tumor Center in Commack, NY (Dr. Jai Grewal)

  4. #4
    Jan. 9, 2012 /PRNewswire/ -- Northwest Biotherapeutics (NW Bio) today announced that it successfully met its projection that it would have 25 trial sites open and recruiting by the end of, 2011, in its ongoing clinical trial of DCVax® immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer.*

    The Company plans to continue adding clinical trial sites, and expects to have at least 30 sites open and enrolling by the end of Q1, 2012. *The Company will also continue pursuing its programs in Europe.* The open and active trial sites are listed on the U.S. Government's website, www.clinicaltrials.gov, and on NW Bio's website, www.nwbio.com*

    As previously stated, the Company's steady progress continues to reflect the growing interest from both physicians and patients, and a growing awareness of the positive data from the Company's prior clinical trials for GBM brain cancer.* In those trials, patients who received DCVax® showed a median survival of 3 years compared with median survival of 14.6 months for patients who received standard of care (surgery, radiation and chemotherapy). *Patients who received DCVax® also experienced a substantially longer time to tumor recurrence: a median of 2 years, compared with 6.9 months in patients who received standard of care.* DCVax® was well-tolerated, with no toxic side effects.

    Linda Powers , CEO of NW Bio, commented that, "It is exciting to see the strong and growing interest from an ever widening array of medical centers across the country.* This is giving us a broad ability to reach GBM brain cancer patients throughout the country, and to provide multiple location choices for these patients."

 

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