NWBT expands clinical sites in ongoing brain cancer trial

Thursday, August 4, 2011 11:36 AM

Northwest Biotherapeutics 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 ongoing clinical trial of DCVax immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. The company also reported that a substantial number of additional sites are in progress. With the 12 sites already open and active, and others in progress, 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 interest from both physicians and patients around the country.  One key basis for the interest has been the positive data from 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). 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. The patients treated with DCVax did not experience any toxic side effects, in stark contrast to chemotherapies.

Another 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.  

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