Northwest Biotherapeutics Receives FDA Clearance For Lung Cancer Trial

Main Category: Lung Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Sep 2006 - 0:00 PDT

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Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBT.OB) today announced that it has received FDA clearance to proceed with Phase I clinical testing of its personalized therapeutic cancer vaccine, DCVax(R)-LB, in non-small cell lung cancer. The clinical endpoints of the trial will be progression-free survival (i.e., delay in progression of the cancer) and overall survival.

DCVax(R)-LB is an extension of the promising DCVax(R) personalized cancer vaccine that has already shown significant delay in disease progression and in extension of survival in clinical trials in two other cancers: Glioblastoma multiforme (primary brain cancer) and prostate cancer. DCVax(R) is a therapeutic vaccine, which is used to treat patients who already have cancer. DCVax(R) is a personalized treatment: it is made from a patient's own dendritic cells that have been "educated" to teach the immune system to recognize and kill cancer cells bearing the biomarkers of the patient's tumor.

"The same DCVax(R) platform can be used for the treatment of many different tumor types, since it incorporates all of the biomarkers from the patient's tumor," stated Dr. Alton Boynton, President of Northwest Biotherapeutics. "DCVax(R)-LB offers several key advantages over existing FDA-approved treatments. To date, DCVax(R) product candidates have shown no toxicity, and have been compatible with other standard therapeutic regimens, including chemotherapy and radiotherapy. In addition, clinical data on delay in disease progression and extension of survival in brain and prostate cancer to date are remarkable."

Lung cancer deaths in the US alone are over 160,000 per year as compared to 30,350 deaths per year for prostate cancer. Existing treatments for non-small cell lung cancer include surgery and radiation therapy, which are used in various combinations. These treatments have significant adverse side effects, and have had little effect on survival. Likewise, chemotherapies used in lung cancer have been highly toxic and have had little effect on survival. In its most recent study, the National Institutes of Health reported that the five-year survival rate for non-small cell lung cancer patients was only 6.2% during 1989-1996. Following initial treatment, virtually all cases of this cancer recur, with a life expectancy of only about one year following recurrence. No effective therapy exists for these patients today.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines, and therapeutic antibodies. The Company's three lead product candidates are: DCVax(R) -Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which is entering a Phase III clinical trial recently cleared by the FDA; DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of newly diagnosed Glioblastoma multiforme, which is entering a large Phase II clinical trial recently cleared by the FDA; and monoclonal antibodies to CXCR4, which are in late preclinical development for the treatment of cancer. For further information, please visit the company web site at http://www.nwbio.com.

Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," 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 initiate, and enroll patients in, the planned Phase II trial of DCVax(R)-Brain and complete the trial on a timely basis, risks related to the company's ability to initiate, and enroll patients in, the planned Phase III trial of DCVax(R)-Prostate and complete the trial on a timely basis, the uncertainty of the clinical trials process and whether DCVax(R)-Prostate or DCVax(R)-Brain will demonstrate safety and efficacy, risks associated with the planned Phase I clinical trial for non-small cell lung cancer and head and neck cancer, and the timely performance of third parties. Additional information on these and other 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 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.

Northwest Biotherapeutics
http://www.nwbio.com

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