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Brain Cancer Treatment to Undergo Broader Testing Based on Encouraging Phase I Clinical Trials

Posted on: 06/01/2005

Brain Cancer Treatment to Undergo Broader Testing Based on Encouraging Phase I Clinical Trials

BOTHELL, Wash., June 1 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics (OTC Bulletin Board: NWBT.OB - News) today announced that it has received clearance from the Food and Drug Administration (FDA) to begin assessment of its dendritic cell-based product candidate, DCVax®-Brain, in a large Phase II clinical trial with approximately 150 patients at 12-15 sites throughout the United States. DCVax®-Brain is a personalized vaccine that is made from a patient's own cells and mobilizes the patient's immune system to attack his or her brain cancer.

The upcoming Phase II trial is based upon promising clinical data from two Phase I clinical trials carried out at UCLA by Linda Liau, M.D., Ph.D., in patients with Glioblastoma multiforme (GBM), the most lethal form of brain cancer. In these two Phase I trials, a total of 25 patients were treated with DCVax® -Brain. Seventeen of these were newly diagnosed GBM patients, and eight were recurrent GBM patients. DCVax-Brain® delivered substantial delays in the time to disease progression and substantial extension of survival times in both groups of patients, compared with the standard of care treatment for such patients. The improvements in time to progression and survival time were significant for both groups of patients, but were larger for newly diagnosed patients than for patients with later stage recurrent disease. In each of the two Phase I trials, the patients received only an initial series of three DCVax®-Brain injections over six weeks, with no booster shots.

With existing standard of care treatment, newly diagnosed GBM patients historically have a median time to disease progression of 8 months and median survival of only 15 months. With DCVax®-Brain, the newly diagnosed patients in the two Phase I trials have a median time to progression of 15 months and median survival time in excess of 26 months. No material toxicity was seen in any of the patients.

Recurrent GBM patients have an even bleaker prognosis with existing standard of care treatment. Historically, their median time to disease progression is only 5 months, and median survival is only 10 months. With DCVax®-Brain, the recurrent GBM patients in the Phase I trial show a median time to disease progression of 13 months, and median survival time of 16 months. No material toxicity was seen.

Dr. Liau stated, "Based upon data seen in two Phase I studies, DCVax® Brain allowed patients not only to live longer but to enjoy more time before disease progression. Glioblastoma multiforme is an aggressive and lethal form of brain cancer. Currently, physicians have little to offer patients with this difficult diagnosis. Broader Phase II clinical studies of DCVax®-Brain will allow us to build upon the promising data seen in our two Phase I studies, and may one day represent a better therapeutic alternative for patients with this deadly tumor type."

Northwest Biotherapeutics' upcoming Phase II trial will focus on newly diagnosed GBM patients, administering DCVax®-Brain early in the course of the disease for maximum impact. In addition, the Phase II trial will include an ongoing regime of booster shots in addition to the initial series of injections.

"FDA clearance of this Phase II trial for brain cancer represents the second major clinical milestone achievement this year for Northwest Biotherapeutics, following FDA clearance in January of a large Phase III trial for prostate cancer," stated Alton L. Boynton, Ph.D., President and Chief Operating Officer. "We are excited about the data to date, showing substantially greater delays in disease progression and improvements in patient survival than any existing treatments have been able to deliver for patients. We are also pleased to see the lack of any material toxicity in patients receiving our DCVax® products."

DCVax® treatments use the patient's own dendritic cells, which are obtained through a simple blood draw. The dendritic cells are then processed, and "taught" to mobilize the patient's immune system to kill tumors, and are then placed back into the patient's body through a simple injection under the skin.

Northwest Biotherapeutics also has DCVax® products for other cancers in clinical trials and in pre-clinical development. In January of this year, Northwest Biotherapeutics received FDA clearance to commence a 612 patient Phase III clinical trial for DCVax®-Prostate, a promising treatment for prostate cancer patients whose disease is no longer being kept in check through hormone therapy, but who have not yet developed metastases. Most prostate cancer patients pass through this stage in the course of the disease, and there is currently no effective therapy for these patients. The Company's Phase III trial will be conducted at 40-50 sites throughout the United States, starting later this year.

About Glioblastoma multiforme

Brain cancer is diagnosed in approximately 200,000 patients per year, of which approximately 40,000 or more are primary brain tumors that do not arise from metastasis of other kinds of cancers, such as breast, lung, or colorectal. Glioblastoma multiforme is the most aggressive and lethal form of primary brain cancer. In addition to their morbidity and mortality in adults, brain tumors are the leading cause of death from solid tumor cancers in those under the age of 20.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on discovering, developing and commercializing immunotherapy products that safely generate and enhance immune system responses to effectively treat cancer without significant toxicity. The company has two lead product candidates:

DCVax®-Prostate is entering a Phase III clinical trial for treatment of non-metastatic hormone independent prostate cancer;

DCVax®-Brain is entering a Phase II clinical trial for newly diagnosed Glioblastoma multiforme.

The company has three technologies that form the basis of its product candidates: a dendritic cell-based immunotherapy platform applicable to multiple cancers; a therapeutic monoclonal antibody technology applicable to multiple cancer types; and a monoclonal antibody-based imaging approach for diagnosis of metastatic prostate cancer.

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 enroll patients in the planned Phase III trial of DCVax®-Prostate and complete the trial on a timely basis, the uncertainty of the clinical trials process and whether DCVax®-Prostate will demonstrate safety and efficacy, risks associated with the planned Phase II clinical trial of DCVax®-Brain and 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 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. -------------------------------------------------------------------------------- Source: Northwest Biotherapeutics, Inc.

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