Advisory Committee

Management

Cardiac Glycoside

History of Cardiac Glycoside Use

The use of plants such as Nerium oleander containing cardiac glycosides for medicinal purposes has been reported in ancient texts for more than 1500 years. They have been used traditionally as folk remedies for a wide variety of maladies and conditions, including abscesses, corns, asthma, dysmenorrheal, eczema, epilepsy, herpes, malaria, psoriasis, ringworm, scabies, sores, warts, abortifacients, emetics, diuretics and heart tonics. Despite their potential to cause side effects, application of plants containing cardiac glycosides for treatment of malignant disease may extend back to Arab physicians in the 8th century. The potential use of cardenolide-like compounds for the treatment of cancer, initially investigated forty years ago, however, was abandoned because of the toxicity of these compounds. It was only recently, that Scandinavian oncologists such as J. Haux have suggested that the apoptosis (cell death) produced by cardiac glycosides such as digitalis in human tumor cells occurred at concentrations that could be achieved without toxicity in humans and, therefore, this agent and plant extracts containing related cardiac glycosides (e.g. oleandrin from Nerium oleander) might be useful for treatment of cancer.

Within the past ten years there has been a substantial increase in the number of studies reported in peer-reviewed science journals that deal with the effects of cardiac glycosides on the growth of human malignant tumor cells. Our understanding of the spectrum of the pharmacologic activities of cardiac glycosides has increased significantly since the discovery of their effectiveness for treatment of congestive heart failure. It is now recognized that certain cardiac glycosides are involved in complex cell signal transduction mechanisms that may have important consequences in their application to the prevention and/or treatment of malignant diseases. Thus, it is reasonable to bring this history of the use of plant extracts containing cardiac glycosides to the point of clinical tests in patients with cancer.

To date, however, there is only a single plant extract containing cardiac glycosides that has been developed for treatment of cancer and completed testing for safety in a Phase 1 clinical trial in the United States. This product is Anvirzel™, a hot-water extract of Nerium oleander.

The published conclusion of the Phase 1 clinical trial states: “Anvirzel™ can be safely administered at doses up to 1.2ml/m2/d (2.4cc). No dose limiting toxicities were found.” This study was conducted at the Cleveland Clinic in Cleveland, Ohio.

Preclinical research conducted at the University of Texas M. D. Anderson Cancer Center, the largest cancer research hospital in the United States, has shown that Anvirzel™:

Blocks activation of a potent signal (NF-kB) that leads to tumor cell proliferation and metastases

Potently inhibits human tumor cell growth of many types although the therapy is not effective against mouse and rat tumor cell lines

Targets a specific enzyme in human tumor…but not normal…cells

Can be used safely under appropriate concerns for cardiovascular function

Represents a unique way to attack and kill human tumor cells that is not shared by any current available chemotherapy or natural product treatment for malignant disease

Acts to enhance radiation mediated killing of human tumor cells

Contains a potent cardiac glycoside that can cross the blood-brain barrier and thus gains access to brain cancers

Anvirzel™ thus offers a unique form of therapy for the treatment of malignant disease that has been well researched. The product is derived from naturally grown Nerium oleander plants in the USA. Anvirzel has been available for patients with confirmed malignant disease for several years through the Salud Integral Medical Clinic in Latin America.  www.saludintegral.hn


 

Nerium

About us

Nerium Biotechnology, Inc., (Nerium) is an international research and development company dedicated to offering solutions that are based on proven science. Nerium’s research and product development has focused on the anti-cancer, anti-viral, and immune-stimulating properties of natural botanical compounds for beneficial use by the consumer. Development of our natural botanical products has been founded on this continuing research at leading medical institutions using the latest scientific methods and technology. The Nerium corporate business and research office is located in San Antonio, Texas.

Nerium Biotechnology, Inc. was incorporated under the Canada Business Corporations Act in 2006 to acquire the assets and liabilities of Phoenix Biotech, LTD (Phoenix BVI), a British Virgin Islands corporation and its five majority-owned Latin American subsidiaries, from Phoenix Biotechnology, Inc., (Phoenix), a Texas corporation. Nerium now owns four Latin American corporations, collectively known as The Salud Integral Group, located in Central America.

Although Nerium and Phoenix are now two (2) separate companies, they have many common shareholders. Both companies continue to receive reflective value from each other. Nerium from Phoenix’s continuing research and associated FDA Clinical Trial at the University of Texas M. D. Anderson Cancer Center in Houston, Texas. Phoenix from Nerium’s continuing anti-viral research at M. D. Anderson and Louisiana State University, as well as various other research and clinical programs.

Research at M. D. Anderson on our natural botanical compounds has led to the rediscovery, identification, and development of a well-defined Nerium Extract from the Nerium oleander plant. Utilizing proprietary extraction technology, this Nerium Extract has provided Nerium the opportunity to develop a pipeline of Nerium oleander-based products. Historical use of the Nerium oleander plant for medicinal applications may extend back to Arab physicians in the 8th century and has been reported in ancient texts and folklore for more than 1500 years. The Nerium oleander plant has been used traditionally as folk remedies for a wide variety of maladies and conditions, including abscesses, corns, asthma, dysmenorrheal, eczema, epilepsy, herpes, malaria, psoriasis, ringworm, scabies, sores, warts, abortifacients, emetics, diuretics and heart tonics.

Field of Nerium Oleander
Farm Operations - Field of Nerium Oleander
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Starting with its U.S.-based, environmentally responsible and earth-friendly farming operations, fields of naturally grown Nerium oleander plants provide the raw material for Nerium’s botanical extract. Nerium has access to 15,000 Nerium oleander plants grown in D’Hanis, Texas, with the capacity to provide renewable raw material for product formulation and production. As the next step, Nerium utilizes a proprietary technology to mill the Nerium oleander leaves and stems for processing into the biomass used for manufacturing of our products.

Salud IntegralToday, Nerium holds a unique position in the international pharmaceutical sector: Nerium has a well-defined oleander extract-based product that represents the “first of its kind” botanical drug containing cardiac glycosides for potent inhibition of the proliferation of cancer (Anvirzel™). Nerium’s Latin American operations, The Salud Integral Group, based in Tegucigalpa, Honduras, integrate the manufacturing, marketing, and sales of Anvirzel™.Two additional products have been approved, HIvialTM and HEP-viralTM by the Health Ministry and a dermal cream application is pending.

Lypohilizer and Laminar Flow Hood
cGMP Manufacturing Facility
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Nerium’s wholly-owned subsidiary, Droguería Salud Integral, S de R.L., has a manufacturing facility in Tegucigalpa, Honduras, that operates under “current Good Manufacturing Practices” (cGMP) standards. The Droguería Salud Integral facility is located inside the pharmaceutical manufacturing plant of Francelia Laboratories, whose cGMP clean room is fully operational and is currently producing Anvirzel™ and the new related products. Quality controls are maintained at each step of production, including field testing, biomass testing, manufacturing facility testing, and product release testing. Product is release-tested at FDA-approved facilities in the United States.

Salud Integral Medical Clinic
Salud Integral Medical Clinic
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Product distribution is provided for through the Nerium subsidiary Salud Integral, S.A. de C.V. (www.saludintegral.hn). The Salud Integral Medical Clinic is located in the Plaza Azul Office Tower, in Tegucigalpa, Honduras.

Nerium’s U.S.-based operations provide for continuing research and new product development. This research is currently focused on anti-viral and topical dermal applications of the Nerium Extract.

Anti-viral research continues under a Sponsored Research Agreement with M. D. Anderson Cancer Center, Department of Virology and Gene Therapy. The end goal for this research is the successful completion of a FDA Clinical Trial for human immunodeficiency virus (HIV) and United States FDA approval of the associated product. Additional anti-viral research is being conducted under a sponsored research agreement at Louisiana State University (LSU) on the Herpes Simplex 1 Virus (HSV-1).

Continuing cancer and anti-viral research on the Nerium Extract has identified the potential for use of this extract in topical skincare applications. This provides Nerium with the opportunity to develop for the consumer an ever expanding pipeline of the “first of its kind” natural botanical healthcare, topical and OTC skin products.

In addition, Nerium’s has developed a new technology, a patent-pending extraction process that provides for the formulation of several new enhanced topical skincare products. This extraction technology incorporates pure liquid Aloe Vera to extract the unique Nerium oleander plant components in a way that preserves the unique and beneficial properties of both plants. The result of this process combines the unique beneficial properties of the Nerium Extract with the known beneficial properties of Aloe Vera.

To date several skincare product safety and clinical pilot studies have been initiated and completed by Nerium with Science, Toxicology, and Technology (ST&T). ST&T is a product research organization located in San Francisco, California.

NeriumSkin CareA new US-based division of Nerium Biotechnology, Inc., Nerium SkinCare has been established for the manufacture and sale of the “first of its kind” natural skincare products for topical use. Nerium SkinCare’s products are founded on the technology, core science, and continuing research of Nerium Biotechnology, Inc. Initially, two (2) new products, NeriumDerm™ a natural skin repair cream and Nerium CS™ a natural cold sore relief serum will be available in FY 2010.

Continuing research, product development, and additional skincare product trials are planned for anti-viral and skin-cancer (Basal, Squamous, and Melanoma) applications under a FDA-IND. With previous research, safety and clinical data gathered from our pilot studies, Nerium believes it will continue to demonstrate safety and have a reasonable expectation of success in a FDA Trial.

As a commitment to quality, Nerium will not compromise on what goes into our products. The quality of Nerium’s products is a direct result of the investment made into the people, scientific research, new technology development, natural farming methods, biomass processing, cGMP production facilities, and product safety testing.

Social Responsibility

Nerium Biotechnology is focusing its research efforts to develop products that conform with the new paradigm for the socially responsible approach to the treatment of cancer as described by the National Cancer Institute.

The new paradigm seeks to develop therapeutic agents and treatment regimens that will enable physicians to eventually deal with cancer as a chronic condition rather than an acute condition and enable patients to live extended lives with a high or improved quality of life.

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