BETHESDA, Md., Sept. 24, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax ® personalized immune therapies for solid tumor cancers, announced today that the MD Anderson Cancer Center Orlando has become the second site participating in the Phase I/II clinical trial of DCVax-Direct, the Company's next generation dendritic cell product for the potential treatment of all inoperable solid tumor cancers.
MD Anderson- Orlando is one of the predominant cancer centers in the Southeast United States. The wide range of cancers treated at the institution make it an excellent fit for this Phase I/II trial which is very broadly targeted, enrolling patients with all types of solid tumors for which surgery is not possible.
DCVax-Direct is a live cell product, composed of dendritic cells (the master cells of the immune system) activated in a proprietary way which may mobilize the natural immune system to reverse the growth of solid tumors, with the goal to kill the cancerous tumor cells and shrink the tumors. The product makes optimal use of the advanced manufacturing system that is proprietary to NW Bio and which delivers cells with maximum immune-activating capacity.Unlike many other live cell products, the DCVax-Direct dendritic cells are injected directly into the tumor tissue where they begin to do their work. Animal experiments have shown that this approach can potentially be highly effective in eliminating established tumors. MD Anderson- Orlando joins MD Anderson- Houston, where the first DCVax-Direct patients have been enrolled, while other patients are going through assessment for eligibility. These two prominent centers bring a very strong combined patient flow, which will help accelerate the enrollment of the trial. In addition, other trial sites in the US and Europe are in various stages of preparation. The primary endpoint of the trial for measuring the efficacy of DCVax-Direct is tumor regression. Since regression may be seen within just a few months of treatment, and since this Phase I/II trial is an open label, unblinded trial, it is anticipated that some initial results from the first patients may be seen before year end.
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