Research

Nerium Biotechnology, Inc., (NBI) is an international research and development company dedicated to science based product development. NBI, in concert with leading medical research institutions, has focused research and product development on the anti-cancer, anti-viral, immune-stimulating, and the dermal properties of natural botanical compounds.

From this research, NBI has rediscovered, identified, and pursues the further development of well-defined constituents from the Nerium oleander plant. Utilizing proprietary technologies; NBI has been able to isolate and extract the core ingredients in a way that preserves the unique components and beneficial properties this plant has to offer. Thus allowing NBI to develop an ever expanding pipeline of “first of class” Nerium oleander-based products.

Dr. Robert A. Newman, Ph.D., Professor Emeritus, Professor of Experimental Therapeutics, Founder and Co-Director of the Pharmaceutical Development Center at the University of Texas M.D. Anderson Cancer Center (MDACC) serves as lead researcher and scientific advisor to Nerium Biotechnology, Inc. His initial characterization and pharmacology research on Nerium oleander components provides the bases for product development and quality control. He continues to assist with continuing research and clinical trials.

Historical Use

Historical use of the Nerium oleander plant for medicinal applications 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 dermatitis, eczema, psoriasis, herpes, sores, abscesses, warts, corns, skin cancer, ringworm, scabies, epilepsy, abortifacients, asthma, malaria dysmenorrheal, emetics, diuretics and heart tonics.

History Of Cardiac Glycoside Use

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 recent 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.

Clinical Use

To date, however, there are only two Nerium oleander plant derived compounds containing cardiac glycosides (oleandrin) that have been developed for the treatment of cancer and completed testing for safety in a Phase 1 clinical trial in the United States. The initial product was Anvirzel™ and the second is PBI-05204.

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. Note: In this trial maximum tolerated dose was limited to volume due to administration of Anvirzel™ by Intramuscular injection (IM).

PBI-05204 completed testing for safety in a FDA Phase 1 clinical trial in the United States at M. D. Anderson Cancer Center in Houston, Texas. The conclusions and the initial findings (abstract) were presented at the annual meeting of the American Society of Clinical Oncology (ASCO). Note: Additional safety levels for oleandrin were reported. This trial provided for safety data at levels beyond the initial Anvirzel™ trial and at levels unexpected for oleandrin with no cardiac events.

A third clinical trial is in process at M. D. Anderson Cancer Center in Houston, Texas.

THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
DIVISION OF CANCER MEDICINE
COMMUNITY CLINICAL ONCOLOGY PROGRAM RESEARCH BASE

PROTOCOL TITLE: A Phase I Study of the Combination of Carboplatin, Docetaxel, and Increasing Doses of Sublingual Anvirzel (Nerium Oleander) in Advance Non-Small Cell Lung CancerTop