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DCVax®-Direct Phase I/II Trial For All Inoperable Solid Tumors Is Expected To Produce Ongoing Results In 2013

In multiple pre-clinical studies of various cancers in animals, direct injection of DCVax-Direct into some of the tumors in each animal resulted in complete clearance of all tumors in 80% to 100% of all of the animals in the various studies – both the tumors that were injected and the tumors that were not injected, indicating a systemic immune response.  Further, the tumors were cleared relatively rapidly: within weeks after the DCVax-Direct injections. 

Equally as important, sixty days after the tumors were cleared from the animals in these pre-clinical studies, the animals were re-injected with the same tumor cells that readily established tumors at the outset of the studies.  This time, tumors failed to establish, indicating immune memory.

The key to this novel approach for potentially fatal inoperable tumors was the NW Bio discovery that partial activation of dendritic cells, in a certain way and to a certain degree, produces dendritic cells that are able to perform both of the two key steps needed to mobilize an overall immune response attacking the cancer.  Neither immature dendritic cells nor fully mature dendritic cells are able to do this.

"Inoperable tumors represent a severe and widespread unmet medical need," commented Linda F. Powers, CEO of NW Bio.  "Some types of cancer are inoperable even as to the primary tumors, and many others are inoperable due to the spread of metastases.  DCVax-Direct can potentially offer an important new treatment option, which can address many or most of these situations.  It is very exciting to contemplate the potential for seeing rapid results in our DCVax-Direct trial later this year, while we continue in parallel to execute our lead program:  our international Phase III trial with DCVax-L for brain cancer."

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, in both the United States and Europe.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal 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/II trials in multiple other cancers. The Company has also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer. 

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