Northwest Biotherapeutics, Inc. Receives Patent Coverage for Antibodies to Primary and Metastatic Cancer Protein Monday March 21, 8:00 am ET
BOTHELL, Wash., March 21 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics (OTC Bulletin Board: NWBT.OB - News) today announced that it has been issued a patent for antibodies to a protein that plays an important role in human cancer, both in primary tumors and in metastasis.
The protein, known as CXCR4, is a chemokine receptor, which is over expressed in more than 65% of human 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. The patent issued is United States patent No. 6,863,887, "Therapeutic and Diagnostic Applications Based on the Role of the CXCR4 Gene in Tumorigenesis." The CXCR4 protein is unique in that it plays an important role in three fundamental aspects of cancer: cancer cell proliferation, invasion and migration, resulting in the seeding of metastatic cells at distant sites such as bone, lung and brain. It is rare for a cancer-related protein to play an important role in all three functional aspects of cancer cells, across many types of cancers. As such, CXCR4 offers an exceptional therapeutic opportunity to prevent proliferation of primary tumors, as well as to prevent metastases.
The patent issued to Northwest Biotherapeutics provides broad coverage for the use of antibodies in preventing and inhibiting the proliferation of cells that over express CXCR4, and for the killing of such cells. Additional issued claims cover the use of antibodies to CXCR4 that are conjugated with a radioactive substance, toxin or drug.
"We are particularly pleased with the CXCR4 patent which came from our gene discovery program, and which will significantly add to our product candidate pipeline," stated Alton Boynton, Ph.D., President, Chief Operating Officer, and co-founder of Northwest Biotherapeutics. "Our preclinical work clearly demonstrates an important role for CXCR4 and its ligand, CXCL12, in tumor cell proliferation, cell migration/invasion and metastasis; three critical functions of cancer cells. The central role of CXCR4 in all three functional aspects of cancer cells, provides multiple therapeutic possibilities, and certainly makes CXCR4 a premier target for novel treatments."
The pre-clinical work by Northwest Biotherapeutics is consistent with the extensive research by others, demonstrating that monoclonal antibodies to CXCR4 can prevent cancer cell proliferation, migration, and establishment of distant metastatic sites using several animal models, including those for breast cancer. Researchers have found that tumors often outgrow their blood supply, and thereby create hypoxic or low-oxygen conditions. The hypoxia results in the expression of CXCR4 which promotes the survival of tumor cells in the hypoxic environment by enabling the cancer cells to proliferate, and migrate away from areas of low oxygen, thus seeding distant metastatic sites in other organs. A positive correlation has been shown to exist in human cancer between CXCR4 expression and establishment of metastatic disease for example in, breast cancer, kidney cancer and acute childhood lymphocytic leukemia.
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. Three technologies form the basis of our product candidates: a dendritic cell-based immunotherapy platform applicable to multiple cancers and currently cleared by the FDA for a Phase III clinical trial in non-metastatic hormone independent prostate cancer, and a Phase II clinical trial for Glioblastoma multiforme; a therapeutic monoclonal antibody product candidate, CXCR4, applicable to multiple cancer types; and an antibody-based imaging agent for metastatic prostate cancer.
Posts: 340 | From: Germany | Registered: Jun 2004
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NWBT...Look at the chart, also (le bed. biz) says its target is 3.0 It has several drugs in all phases of clinical trial and the biggest one in PHASE III...for lung cancer.....Its gonna be at 100% up in one week.
-------------------- This is not a recommendation to buy or sell securities. Posts: 1206 | Registered: Feb 2006
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Jelly this is a long one for me....I am putting it in my safe and forgetting ab it....The target according to nmy own DD is 3.0....Amazing..Lets have a good run in am as well
-------------------- This is not a recommendation to buy or sell securities. Posts: 1206 | Registered: Feb 2006
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If it gets clear this stock would see at least 3.0....thats where most of the drug companies in initial phases have been settling in last few years. I think this would also settle in there....In one year....
DCVax® - Prostate: Phase III
Development stage: DCVax®-Prostate is entering a Phase III clinical trial that was cleared to proceed by the Food and Drug Administration in January of 2005. Data from a Phase I/II clinical trial demonstrated overall safety of DCVax®-Prostate, as well as the induction of strong immune responses. Clinical data suggested delayed times to progression of disease, especially in patients with no metastatic disease at entry.
Trial design: The Phase III clinical trial is a randomized, multi-center, double blinded clinical trial that will enroll 612 patients in the United States.
Indication: Patients with hormone independent, non-metastatic prostate cancer will be eligible for participation in this clinical trial. Other eligibility criteria include requirements around absolute PSA levels as well as PSA doubling time.
Endpoints: The primary endpoint for the Phase III clinical trial is survival free of disease progression. The first secondary endpoint is survival free of the development of symptoms arising from progression of disease. Other endpoints include the induction of immune responses, and overall survival.
Product: DCVax®-Prostate is manufactured using a patient’s own dendritic cells, loaded with a recombinant form of Prostate Specific Membrane Antigen (rPSMA). The dendritic cells are generated from monocytes obtained through a single leukapheresis.
Immunization schedule: Immunization starts when eligible patients have met all entry criteria, including the specified absolute PSA level and PSA doubling time. Immunizations will be given at weeks 0, 2, 4, 8, and at months 3, 6, 9, 12, 18, 24 and 30.
Previous Phase I/II Clinical Trials
The Phase I/II study evaluated 32 patients with hormone independent prostate cancer, both non-metastatic and metastatic. Twelve patients entered the study with no radiological evidence of metastatic disease, and 20 had between one and three bone and/or lymph node metastases.
The natural history of prostate cancer indicates that patients with rising PSA values while on hormone treatment progress to metastatic disease on average in about 28-36 weeks, dependent upon several prognostic factors such a PSA velocity, time on anti-androgen therapy and nadir PSA while on anti-androgen therapy. In the non-metastatic group of patients (n=12), none had progressed at 28 weeks and only half had progressed at 59 weeks. The delay of progression to metastatic disease during long-term follow-up of this subset of patients appears correlated with stabilization of PSA levels. This is the patient population that the company will focus on in the Phase III clinical trial. The data also very clearly indicate a highly specific PSMA antibody response, and a highly specific and strong T cell response to PSMA in about 85% of the patients treated with DCVax®-Prostate. Northwest Biotherapeutics’ hypothesis is that administration of DCVax®-Prostate will enhance progression free survival relative to placebo, delay the development of symptomatic disease and increase overall survival.
Northwest Biotherapeutics Presents New Data on Monoclonal Antibody to CXCR4 Wednesday March 1, 7:30 am ET Lung Metastases Reduced 75% in Preclinical Studies
BOTHELL, Wash., March 1 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics (OTC Bulletin Board: NWBT.OB - News) 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.
-------------------- This is not a recommendation to buy or sell securities. Posts: 1206 | Registered: Feb 2006
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