NW Bio Activates Second Site in DCVax-Direct Phase I/II Trial

MD Anderson Cancer Center Orlando Is Now Also Enrolling Patients

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Sep 24, 2013, 08:15 ET

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.

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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.

Dr. Marnix Bosch, Chief Technical Officer of NW Bio observed, "It is a tremendous honor for us to work with these two world-class institutions for this trial. The teams at both of these medical centers are bringing a high level of dedication to this groundbreaking study, which may help create better chances of success. We appreciate the expertise and motivation that we have experienced through the entire training and treatment processes, and look forward to working with both teams on an ongoing basis."

Dr. Mark Roh, President of MD Anderson-Orlando, states, "We are very excited to be joining this clinical trial to further advance cancer care and possibly expand treatment options to cancer patients. Our oncologists and staff are dedicated to providing our patients with every opportunity to fight their disease, and being a part of this trial will give additional research options to the brave men and women who walk through our doors."

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 U.S. 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 has also received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and is currently conducting a 60 patient Phase I/II trial for direct injection of a more potent dendritic cell into all inoperable solid tumor cancers. The Company has also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.

Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," 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