Northwest Biotherapeutics Presents New Data On Monoclonal Antibody To CXCR4

BOTHELL, Wash., March 1 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics today announced new preclinical data on the efficacy of a monoclonal antibody to CXCR4, one of the most important cancer targets discovered in recent years. The new data showed a significant reduction in metastases to the lung, as well as a significant reduction in primary breast cancer tumor growth and significant extension of survival, after treatment with NWBT’s monoclonal antibody to CXCR4. A growing body of research and literature has shown that CXCR4 plays a central role in all three stages of cancer progression, and does so in over 75% of all cancers. NWBT holds broad issued patent coverage for the use of antibody therapeutics targeting CXCR4, as announced in March 2005. The data were presented at the Cambridge Healthtech Institute’s 13th Annual Molecular Medicine Tri-Conference, February 22nd and 23rd, in San Francisco, CA.

It is now well documented that CXCR4 plays an important role in all three major aspects of cancer progression: proliferation of the primary tumor, migration of tumor cells away from the primary tumor, and invasion and establishment of metastases at distant sites such as bone, lung and brain. Northwest Biotherapeutics conducted a series of preclinical studies to test a monoclonal antibody to CXCR4 in three cancer models. The studies were designed to determine whether blocking CXCR4 function would impact primary tumor growth, metastases and survival. The findings reported showed that anti-CXCR4 antibodies significantly impacted all three of these aspects:

-- Median survival more than doubled, with 95% of the treated animals surviving >110 days compared with median survival of 45 days in control animals; -- Lung metastases were reduced by 75%; -- Growth of primary breast tumors were reduced by 60%.

“It is rare for a single protein or target to play an important role in all three functional stages of cancer cells, let alone to do so across so many types of cancers,” stated Dr. Alton Boynton. He continued, “CXCR4 offers an exceptional therapeutic opportunity both to prevent growth of primary tumors and to prevent the metastatic spread of the disease. Most importantly, the effect of anti-CXCR4 antibodies does appear to correlate with significant extensions of survival. Often, drugs that slow tumor growth do not correlate with significant extensions of survival. Strong preclinical results such as those we have presented with our anti-CXCR4 antibodies warrant the initiation of a Phase I clinical trial in patients. We plan to move this antibody into the clinic.”

CXCR4 has been found to be over-expressed in more than 75% of all cancers, including breast, ovarian, lung, colon, prostate, kidney, melanoma, brain, esophageal, pancreatic, and many forms of leukemia, and childhood cancers such as acute lymphocytic leukemia and neuroblastoma. Furthermore, CXCR4 expression has been shown to correlate with poor survival, in studies by multiple independent investigators. NWBT has previously completed and reported on several in vitro preclinical studies using monoclonal antibodies to block CXCR4 receptor function, resulting in significant inhibition of cancer cell proliferation, migration and invasion in several cancer models.

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; DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of newly diagnosed Glioblastoma multiforme, which is entering a large Phase II clinical trial; and monoclonal antibodies to CXCR4 in late preclinical development for the treatment of cancer. For further information, please visit the company web site at 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 obtain FDA clearance to initiate a Phase I clinical trial for CXCR4 and the uncertainty of the clinical trials process. 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.

Northwest Biotherapeutics

CONTACT: Lorie Calvo of Northwest Biotherapeutics, +1-425-608-3008(Pacific)

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