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ANVIRZEL^TM  (oleander)

Cytotoxic Agent for Cell Proliferative Disease (Cancer)

Immunomodulatory Agent for Immune Disorders

ANVIRZEL^TM is an internationally patented non-toxic aqueous extract of Nerium oleander composed of both polar and non-polar compounds, and contains 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.

An extract of oleander (Nerium oleander) that contains oleandrin is effacious in the treatment of tumors. This use is species-specific and is correlated with Na, K-ATPase isoforms. Additionally, oleandrin raises the intracellular calcium level, releases cytochrome C from mitochondria, and induces apoptosis through a caspase-dependent pathway.

Also, oleandrin inhibits the release of tumor growth factor bFGF from tumors. bFGF has many tumor-proliferating effects including promoting angiogenesis.

Oleandrin was determined to block the activation of NF-kB, which in turn blocks the cell-survival function of NF-kB. In addition, a non-water-soluble fraction of oleander is able to produce oxygen free-radicals in tumor cells, which may contribute to tumor cell injury and death. Oleandrin, particularly when in the context of oleandrin and oleander extract, is able to cross the blood-brain-barrier.

Evidence suggests that oleandrin and oleander extract have antiviral activity. Development continues as the oleander extract is nontoxic to normal cells and exhibits multiple antitumor activities such as inducing apoptosis, reducing molecular mechanisms of cell survival, and inhibiting tumor-promoting factor bFGF-2.

Research

Extensive in vitro research has been conducted by leading research institutions in the United States of America. One of these institutions has tested ANVIRZEL™. against a broad spectrum of human malignant cell lines, and has demonstrated that ANVIRZEL™ has inhibitory activity against them.

In addition to the cancer research being conducted by the M.D. Anderson Cancer Center, concurrent research has confirmed that ANVIRZEL™ has been "shown to stimulate the immune system by stimulation of the function and capability of specific subsets of mononuclear cells." In addition, research has shown that ANVIRZEL™ specifically stimulates T and B lymphocytes, the cell-mediated and the humoral mediated immune systems.

Anvirzel™ has been the subject of eight prestigious peer-reviewed journal publications.

Is Anvirzel^TM Safe?

In April 2000, the United States Food and Drug Administration approved a study entitled "Phase I Study of ANVIRZEL^TM in Patients With Advanced Solid Tumors" was commenced under the direction of Ronald Buckowski, M.D. at Cleveland Clinic in Cleveland, Ohio.  The abstract of their findings was presented at the 2001 annual meeting of the American Society of Clinical Oncology.  This abstract states:  “Anvirzel^TM can be safely administered at doses up 1.2 ml/m²/d.  No dose limiting toxicities were found.”

Indications

Because of it's strong cytotoxic effect in combination with an equally strong immunomodulatory effect, ANVIRZEL™ is useful as a therapy, both primary and adjuvant, for cell proliferative disease (cancer), certain viral disease, and autoimmune/inflammatory disease. Clinical application of ANVIRZEL™ in the United States, Ireland, and Honduras have demonstrated inhibitory activity against various neoplastic disease, hepatic disease such as Hepatitis C, as well as autoimmune/inflammatory disease such as psoriasis. The results have been determined both by the clinical practitioner and independent laboratory analysis using PET, CT scan, MRI, and hematological screening.

Anvirzel™ has also been used successfully as a combination therapy with various chemotherapeutic agents, as well as with radiotherapy.

International Clinical Experience Using ANVIRZEL^TM 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 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.

Observed Side Effects

No negative side effects have been reported by clinicians and patients undergoing Anvirzel^TM therapy. One case of X-ray potentiation while undergoing adjuvant Anvirzel^TM therapy has been reported. One case of tachycardia, which may or may not be related to use of ANVIRZEL^TM, has been reported.

"Common Thread" in Clinical Experience with ANVIRZEL^TM

The "Common Thread" running through almost all of the clinical records of the patient population using ANVIRZEL™ 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 ANVIRZEL^TM

Every production run of ANVIRZEL™ is release tested for quality control by laboratories in the U.S. approved by the USFDA prior to patient sales. 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 ANVIRZEL^TM 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 Anvirzel^TM therapy.

Conclusion

ANVIRZEL^TM, in both in vitro and in vivo experience has demonstrated inhibitory activity against a broad spectrum of cell proliferative disease (cancer), viral disease, and autoimmune/inflammatory disease.

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