Skin Research

From historical/anecdotal use, continuing cancer and antiviral research with Nerium oleander extracts, Nerium Biotechnology, Inc. (NBI) has identified the potential for use of Nerium Ingredients in topical skincare applications. NBI’s proprietary technologies and product formulation provides for Nerium Ingredient’s to be the key ingredient in each product that will be designed and formulated for a specific target. This provides NBI with the opportunity to develop for the consumer an ever expanding series of natural botanical healthcare, topical, cosmetic and OTC skin products.

New Extraction Technology

NBI has developed a new technology; a patented process NBio-PL²™ (Plant-to-Plant process) that provides for the formulation of numerous new enhanced topical skincare products. This proprietary technology incorporates pure liquid Aloe Vera as the media used to acquire the unique Nerium oleander plant components in a way that preserves the unique and beneficial properties of both plants, without additional solvents. The result of this process combines the unique beneficial properties of the Nerium oleander plant with the known beneficial properties of the Aloe Vera plant, providing the NAE-8® ingredient for topical product formulation.

Historical Use (Nerium oleander plant)

Nerium Oleander PlantHistorical 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.

Historical Use (Aloe Vera plant)

The Aloe Vera plant has been well known for centuries for its healing properties; the raw plant and commercial preparations can be used, and both oral intake and topical dressings have been documented to facilitate healing of any kind of skin wound, burn, or scald - even speeding recovery time after surgery. Historical use includes blisters, insect bites, rashes, sores, herpes, urticaria, athlete's foot, fungus, vaginal infections, conjunctivitis, sties, allergic reactions, and dry skin. Other topical uses include acne, sunburn, frostbite (it appears to prevent decreased blood flow), shingles, screening out x-ray radiation, psoriasis, preventing scarring, rosacea, warts, wrinkles from aging, and eczema. Top

Research

NBI is continuing independent research for topical skin application with the patented NAE-8® ingredient and NeriumAD products. This research is being conducted at two contract research facilities (on the East and West Coast) and at a well-known US academic institution. Several publications are in process and data will be peer-reviewed and published at the appropriate time.

Safety and Clinical Testing

Research for NAE-8® safety and clinical application was initiated with ST&T Research (Science, Toxicology & Technology). ST&T Research is comprised of a group of prominent scientist, including M.D. and Ph.D. pharmacologists/toxicologist and research product development oriented physicians, scientist, and regulatory compliance specialists which include a legal team specializing in US FDA/FTC/Customs regulations. ST&T Research provides product development, product compliance, regulatory compliance, clinical testing, and information and data for safety and efficacy.

Dr. Robert A. Newman as scientific advisor to NBI provided assistance to ST&T. With data from previous research studies, clinical trial experience, and utilization of validated analytical methods, Dr. Newman assisted with NAE-8® safety support and analysis.

ST&T Research initiated clinical human studies (4) for safety with topical application of a base cream which included the NAE-8® ingredient. The NBI topical test article application was first applied as a spot treatment, then to increasingly larger areas of skin application with each new clinical study to evaluate absorption. The studies included participants that exhibited various skin conditions to assist in the evaluation of the absorption of the NBI topical test article with different skin conditions. A variety of compromised/damaged/broken skin conditions were presented as the application coverage area increased (age spots, actinic keratosis, acne vulgaris, sunburn, and fever blisters/cold sores). Two (2) of these clinical studies included a comparison to well-known OTC products currently available to consumers.

Each study's primary end-point was to evaluate the NBI test articles for safety/toxicity, a) Determine if the Nerium oleander metabolites were being absorbed through the skin, b) If so, how much, c) If there was any noticeable blood pressure or heart rate changes, and d) If there were changes in blood chemistry or organ system functions. In addition, subjects were observed for inflammation, rash, or tenderness possibly related to the cream application.

ST&T Research utilized blood chemistry and CBC analysis whereby a comparison was made of the participant's initial baseline results with additional measurements taken throughout the study. As an example, participant blood samples were taken on day one (1) (one hour after cream application), day seven (7), day fifteen (15), and on day thirty (30) of NAE-8® use to test for absorption and accumulation.

Analysis was non-eventful. The analysis showed all subjects within normal ranges, there were no detectable metabolites absorbed systemically and no adverse reactions noted. With regard to efficacy, ST&T was surprised to find there were a statistically significant number of subjects reporting positive results since the NBI test articles contained no "additives or cleansing compounds" like the OTC products.

Investigators: Science, Toxicology & Technology and its physicians / health care practitioners.

Sponsor: Nerium Biotechnology Inc. (Nerium)

Product Clinical Testing, with Safety Components

With completion of these initial NAE-8® safety trials, continuing research and newly formulated products (NeriumAD Night Cream, NeriumAD Day Cream, etc.) have proceeded to clinical trials and the consumer market. The clinical results of these trials have continued to demonstrate safety and the effective use of these products as a topical application for the consumer.