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NW Bio Has Initiated Its DCVax®-Direct Phase I/II Trial for All Solid Tumor Cancers


6/13/2013 2:38:55 PM

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BETHESDA, Md., June 13, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that its 60-patient Phase I/II clinical trial of DCVax-Direct for all inoperable solid tumor cancers has been initiated at The University of Texas MD Anderson Cancer Center in Houston, Texas.

(Logo: http://photos.prnewswire.com/prnh/20110329/SF73084LOGO)

DCVax-Direct offers a potential new treatment option for the many clinical situations in which patients' tumors are considered inoperable either because of the location or type of cancer, or because of the spread of multiple tumors.  A large number of patients with lung, colon, pancreatic, liver, ovarian, melanoma, head and neck, and other cancers such as sarcomas face this situation today, and it carries a bleak prognosis.

The excellent reputation and broad experience of the clinical trial team at MD Anderson makes them an ideal choice to initiate this study.  It is anticipated that multiple other leading centers in both the US and UK will be joining as trial sites as well.  Since the Company's announcement of plans for this trial, NW Bio has received inquiries from both patients and medical centers across the country seeking to participate.

The trial is expected to enroll groups or "cohorts" of patients with numerous different types of cancers, including pancreatic, colon, liver, melanoma, and various other cancers.   

The trial is a combined Phase I and II trial.  In the Phase I stage, the trial will test various dose levels of DCVax-Direct.  The trial will then proceed directly into the Phase II stage to test the efficacy of the DCVax-Direct treatment.  The primary endpoint for measurement of efficacy will be tumor regression (i.e., shrinkage or elimination).

As is standard with Phase I/II trials, this trial will not be blinded the clinical results in patients will be seen as the trial progresses.  Accordingly, it is anticipated that early results of the trial may be emerging throughout the remainder of 2013.

Pre-clinical animal studies showed that injection of partially mature dendritic cells resulted in eradication of tumors -- both tumors that were injected with DCVax-Direct and tumors that were not injected (indicating a systemic immune response).  In addition, after the animals' tumors had been eradicated, when the animals were injected again with tumor cells later on, tumors failed to develop in these animals (indicating immune memory).

The key to DCVax-Direct is the use of partially matured dendritic cells. These specially prepared dendritic cells have the ability to pick up tumor antigens (i.e., tumor biomarkers) from tumor cells inside the tumor after the dendritic cells are directly injected into the tumor.  After picking up the antigens, these dendritic cells also have the ability to travel to lymph nodes and mobilize the immune system to attack tumors throughout the body which express these antigens.  NW Bio holds strong patent coverage on both the manufacturing processes and the use of such partially matured dendritic cells.

"We are very pleased to be teaming up with an institution with the depth, caliber and reputation of MD Anderson to initiate our highly novel, first-in-man Phase I/II trial of DCVax-Direct for all inoperable solid tumor cancers," Linda Powers, CEO of NW Bio noted.  "After years of painstaking development, we could not ask for a better clinical partner to explore the potential of DCVax-Direct to achieve some tumor regression in patients with inoperable tumors."

According to the primary investigator, Dr. Vivek Subbiah, MD (Assistant Professor in the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, which is responsible for the institution's early stage clinical trial programs), "Dendritic cell cancer vaccine therapy is a new and innovative therapeutic approach in our battle against cancer.  Dendritic cell technologies have been advancing, and prior studies have shown encouraging results.  Patients with inoperable tumors face very bleak prognoses, and have an urgent need for new treatment options.  This innovative first-in-human study of NW Bio's DCVax-Direct for inoperable tumors in multiple types of cancer is a crucial step forward for a new approach."

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 form of 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 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



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