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

Aug 04, 2011, 08:30 ET from Northwest Biotherapeutics

BETHESDA, Md., Aug. 4, 2011 /PRNewswire/ -- Northwest Biotherapeutics (OTC.BB: NWBO) 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.

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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)

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to 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/or about the Company, please visit the Company's web site at www.nwbio.com.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM using DCVax®-Brain and future clinical trials, 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 its clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy.  Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") 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 from 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.    

SOURCE Northwest Biotherapeutics



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