Cancer Research

M.D. Anderson Overview

Pharmacology and Development of Nerium oleander-based Cancer Therapy

Nerium Biotechnology, Inc. (Nerium) holds a unique position in the international pharmaceutical sector: Nerium has a well-defined Nerium 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™).

Cancer research at The University of Texas M. D. Anderson Cancer Center has demonstrated that components of Anvirzel™ are active on dual pathways at the cellular level to promote apoptosis and/or autophagy (cell death) in human tumors but not normal cells. The ten (10) plus years of research performed by The University of Texas M. D. Anderson Cancer Center has led to the publication of twelve peer-reviewed journal articles that describe Anvirzel™ (Nerium oleander extract) and its components (oleandrin). These twelve articles present the body of research conducted by Robert A. Newman, Ph.D., as Founder and Co-Director of the Pharmaceutical Development Center, Department of Experimental Therapeutics, at M. D. Anderson Cancer Center in Houston, Texas. Dr. Robert Newman remains actively involved in continuing research as Scientific Advisor to Nerium Biotechnology, Inc.

Dr. Newman has developed analytical methods for the characterization and quantification of the cardiac glycosides oleandrin, odoroside, neritaloside and the aglycone oleandrigenin, all contained in the extract of Nerium oleander (Anvirzel™). He has applied this analytical method to the determination of oleandrin in human plasma following administration of Anvirzel™. This initial characterization and pharmacology research of the major biochemical and biological properties of the extract has served as a basis for quality control for the production of Anvirzel™ and all additional new product development.

Anvirzel™ is an 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.

This preclinical research has shown that Anvirzel™:

Potently inhibits human tumor cells of many types (induces Apoptosis, Autophagy).

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 (Species specific).

Targets a specific enzyme subunit (alpha-3) 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.Top

Clinical Research

The published conclusion for the Anvirzel™ 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.

A new clinical study is in process for Anvirzel™. The Integrative Medicine Program at M. D. Anderson has initiated a request to research Anvirzel™ as a complementary/adjuvant therapy (FDA Phase 1 Study of Anvirzel™ utilizing chemotherapy and Anvirzel™ administered by sublingual application). This research will be funded by the National Cancer Institute (NCI) through the Clinical Community Oncology Program (CCOP). Preparation for this trial is currently in process (IND application, IRB approval, Protocols, Investigator’s Brochure, etc.) with a projected start date in FY 2012.

In addition, completion of a recent FDA Phase I clinical trial sponsored by Phoenix Biotechnology, Inc. for PBI-02504 (Nerium oleander extract) at M. D. Anderson Cancer Center in Houston, Texas has indicated an additional safety range for the administration of cardiac glycosides (oleandrin). The publication of conclusions is in process and the initial findings (abstract) were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2011.

New Cancer Paradigm

Nerium Biotechnologyis 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.

When he was Director of the National Cancer Institute, Dr. Andrew von Eschenbach (currently FDA Director), in speaking about the new paradigm for cancer therapy, stated: “And we tended to think in terms of looking for the silver bullet. In the new paradigm it’s not going to be a silver bullet; there’s not going to be one treatment. There’s going to be a portfolio of treatments tailored for a particular situation and we’re not necessarily always going to completely eradicate cancer but we’re going to control it. And cancer will be thought of more as a chronic disease than an acute disease. So what we’ll see in this crystal ball is our ability to not necessarily completely cure or eradicate but control and suppress and allow someone to live a full rich life and die of some other reason.”  Clinical data gathered from patient experiences demonstrate that Nerium’s flagship product, Anvirzel™, looks to find its place in this new paradigm.Top