AnvirzelTM United States Patent # 5,135,745 Ann's NOTE: You just have to love the Internet-here is what I found. Cytotoxic Agent for Cell Proliferative Disease (Cancer) Immunomodulatory Agent for Immune Disorders The Product ANVIRZELTM is an internationally patented non-toxic aqueous extract of Nerium oleander composed of both polar and non-polar compounds, and containing at least five polysaccharides, two cardiac glycosides, and five proteins. It is packaged in 10ml vials as a lyophilized powder for reconstitution with bacteriostatic water. Mechanism of Action Extensive laboratory and clinical experience indicate both cytotoxic and immunological activities for the drug. In developing a protocol for clinical trials, M.D. Anderson Cancer Center states, "It is thought that the polysaccharides present in ANVIRZELTM are capable of activating the immune cells, which in turn can recognize the epitopes present on the cancer cell surfaces, thereby enhancing the efficacy of the immune response. It is believed that the cytotoxic action present in the extract may be essential for synergistic activities. It is believed that the cytotoxic action both arrests tumor growth and prevents cancer cell reproduction as well as having and/or producing a Tumor Necrosis Factor like activity. It is essential that all the constituents in ANVIRZELTM be administered to invoke a synergistic effect on the stimulation of the immune system." Tumor Necrosis Factor Liberation Tests have been conducted according to Stimpel, et al on ANVIRZELTM, and the results are preserved in the company files. Continuing research has proved conclusively that AnvirzelTM is active on dual pathways at the cellular level to both inhibit the growth of tumor cells and to promote apoptosis of the tumor cells. Research Extensive in vitro research has been conducted by Dr. Robert Newman, Chief of Pharmacology, M.D. Anderson Cancer Center(MDACC), Houston, Texas. Dr. Newman has tested ANVIRZELTM. against a broad spectrum of human malignant cell lines, and has demonstrated that ANVIRZELTM has a high order of efficacy. In addition to the research being conducted by M.D. Anderson Cancer Center, concurrent research is being conducted by Dr. Wendell Winters, a noted immunologist with the University of Texas Health Science Center in San Antonio,Texas. Dr. Winter's work has confirmed that ANVIRZELTM has been "shown to stimulate the immune system by stimulation of the function and capability of specific subsets of mononuclear cells." In addition, Dr. Winters' research has shown that ANVIRZELTM specifically stimulates T and B lymphocytes, the cell-mediated and the humoral mediated immune systems. United States Food and Drug Administration Approved Clinical Trials In April 2000, a USFDA approved study entitled "Phase I Study of ANVIRZELTM in Patients With Advanced Solid Tumors" was commenced under the direction of Ronald Buckowski, M.D. at Cleveland Clinic in Cleveland, Ohio. Indications Because of it's strong cytotoxic effect in combination with an equally strong immunomodulatory effect, ANVIRZELTM is indicated as a therapy, both primary and adjuvant, for cell proliferative disease (cancer), certain viral disease, and autoimmune/inflammatory disease. Clinical application of ANVIRZELTM in the United States, Ireland, and Honduras have demonstrated efficacy against various neoplastic disease, hepatic disease such as Hepatitis C, late and early stage HIV/AIDS, as well as autoimmune/inflammatory disease such as rheumatoid arthritis and psoriasis. The results have been determined both by the clinical practitioner and independent laboratory analysis using PET, CT scan, MRI, and hematological screening. International Clinical Experience Using ANVIRZELTM Therapy International clinicians have been treating patients suffering from the above referenced disorders on a compassionate use basis since 1997. Many of these patients were previously diagnosed as terminal. These clinicians have experienced a very high level of success with disease stabilization, partial remission, and complete remission, almost always accompanied by a very marked improvement in the patients' quality of life. The company is directing all new patients to the Honduran clinic. Dr. Anibal Villatoro of Tegucigalpa, Honduras, Former Executive Director of the Honduran Institute of Social Security (administrator of the public health system) has since January of 1999 been conducting a compassionate use trial with ANVIRZELTM for HIV (SIDA) patients in Tegucigalpa. His early results indicate a strong level of response to ANVIRZELTM therapy with a feeling of homeostasis (feeling of well being) and an improved quality of life, as well as significant improvement in their immune systems. Observed Side Effects No negative side effects have been reported by clinicians and patients undergoing AnvirzelTM therapy. One case of X-ray potentiation while undergoing adjuvant AnvirzelTM therapy has been reported. One case of tachycardia, which may or may not be related to use of ANVIRZELTM, has been reported. "Common Thread" in Clinical Experience with ANVIRZELTM The "Common Thread" running through almost all of the clinical records of the patient population using ANVIRZELTM on a compassionate use basis has been the marked improvement in the "quality of life" of those patients. This includes, but is not limited to, homeostasis, marked improvement in pain management with elimination of or marked reduction in use of analgesics, positive response to antibiotics, increased appetite with concomitant weight gain, and increase in energy with reduction of fatigue. Standardization and Testing of ANVIRZELTM Every production run of ANVIRZELTM is subjected to six tests for assay, contamination, and standardization in independent laboratories subject to U.S. F.D.A. testing. The standardization test is a proprietary test developed in conjunction with M.D. Anderson Cancer Center, Houston, Texas. Additionally, each production run is tested for efficacy in vitro against melanoma (BRO). Toxicity Studies A toxicity study was performed by Southern Research Institute, Birmingham, AL, on 28 beagle dogs, and the study states, "No clinical signs of toxicity were noted in any of the dogs in this study..." Another lethality assessment of ANVIRZELTM in a murine (laboratory mouse) population was conducted by Southwest Research Institute, San Antonio, TX., and the study states, "On the day of NOI (Nerium Oleander Extract Injectible) administration and over a subsequent 14 day post dose period, none of the treated animals showed any pathological signs or ill effect of the injections as assessed by daily morbidity and mortality observations." No reports of toxicity have been received from clinicians supervising patients experiencing AnvirzelTM therapy. Conclusion ANVIRZELTM, in both in vitro and in vivo experience has demonstrated a very high order of efficacy against a broad spectrum of cell proliferative disease (cancer), viral disease, and autoimmune/inflammatory disease. 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