Northwest Biotherapeutics (NWBT) announced that it has expanded its number of clinical trial sites, and now has 12 sites across the US 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 tumour for approximately 2 years, on average, as compared with tumour 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 Centre 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-tumour 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 Centre in Cleveland, OH (Dr Andrew Sloan), Virginia Piper Cancer Centre 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 Centre in Sacramento, CA (Dr Nora Wu) and Long Island Brain Tumour Centre in Commack, NY (Dr. Jai Grewal).

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.