“Everything is theoretically impossible, until it is done.”

Robert A. Heinlein.

Ancient Origins

Although there is no established record of when plants were first used for prehistoric medicine purposes, plants as healing agents with clays and soils are ancient. Mixing these elements became prehistoric medicine practiced in Egypt, China, India, and many other cultures for 1000’s years.

Aboriginal people are still known to directly apply specific types of plants and soils onto their fresh wounds. Mud, or, more accurately, sediment, was carefully selected from particular waterholes to relieve and act as a physical barrier to retard or even kill infection on open wounds.

During the Age of Enlightenment, scientists began to move from botanicals to synthetic drugs through organic chemical synthesis. To provide consumers with protection and control over their use, the government created various laws and regulations. These vary in developing countries governing the patenting, testing, safety, efficacy, marketing, and distribution of each drug.

Producing a drug creates a high cost to develop a claim, clinical trials, and a consistent manufacturing process of stability in a controlled cGMP facility. This high cost makes the nonpatentable ancient medicine unable to become a drug and claim any form of efficacy, disallowing their low cost and benefits simply because there are no financial resources to do so.

The founders of the Ionic Alliance Foundations quest was developed over investigating specific exothermic chemical reactions that would occur using synthetic chemicals easily accessible in today’s markets. These reactions were isolated and simulated in controlled pharmaceutical production methods to acquire nature’s secrets in a tolerance-oriented repeatable formulation.

Over many years of exploring the actions of prehistoric medicine and the current requirements of the regulations, our inventors developed a new method of delivery to a biological system.

Ion Biotechnology® Aqueous Ligands

The Ion Biotechnology® Aqueous Ligands “IBAL” is a coordination complex of molecules with a polarized hexaaqua ligand system of ionic metals and salts. An IBAL is a synthesized ionophore that actively transports free ions through cell membranes within the cellular environment. A natural carrying system of molecules equilibrated ionic complexes and electrons that target cellular metabolism deliver a biological system’s biologically desired function.

It consists of a central metal atom or cation bonded to one or more ligands in an H2O soup of free ions, ionic salts, and molecules containing one or more pairs of electrons that may be shared with the hexaaqua metal cations. The metal ion in solution does not exist in isolation but in combination with shifting ligands.

Current IBAL formulations in a ligand structure are Hydrogen, Oxygen, Ammine, Sulfur, Copper, Zinc, Magnesium, Manganese, Selenium. IBAL ratios are formula specific, designed, and dose-dependent for the purpose and efficacy of each finished product.

The Science

In Science, Chemistry, and Biology, there are centuries of theories. When “the need for” uses innovation to develop physical substances that address a combination of these theories, it becomes an invention of a composition.

Ion Biotechnology® relates to a combination of sciences in inorganic/organic chemistry, redox values, pH, molecular biology, pharmacokinetics to treat mammalian cells and destroy harmful anaerobic cells to establish biological homeostasis.

There is a global need for improved treatment regimens that are more effective, safe, tolerable, reduced side-effects, shorter in duration, and affordable due to reduced manufacturing costs. A solution having the ease of administration, access, distribution, and extended storage life for low-income and remote localities.

Society needs a nontoxic delivery system that is designed to target biological functions naturally. A method of delivery that can be used safely over a multitude of regulated sectors in personal care, nutrition, and drug delivery. A preventative, adjunct, or primary therapy based on the individual’s economic or efficacious need. A process to manufacture that is cost-effective, repeatable, stable, and scalable. Antibiotics, one of the greatest inventions in modern medicine, now have a natural replacement.

The need for a method of disease prevention allowing for continued research in redox medicine (pro-oxidant and antioxidant agents in cells) and biologic systems therapeutic uses of excitation energies in complex ion structures that deliver positive bonding (“cations”) to oxidative free radicals (“anions”). Rebox biology is the building block of redox switches, and redox relays in clinical proteomics and metabolomics to reduce oxidative and nitrosative stress.

Exogenous nutrient elements modulate the energetic metabolism responses that are prerequisites for cellular homeostasis and metabolic physiology. Specifically, the delivery of micronutrients in the form of metals is critical in oxidative stress and cytoprotection processes. Commonly administered minerals and drugs are not in a highly bioavailable form nor target the immediate therapeutic or nutritional need. They are widely unable to cross through a hydrophobic lipid bilayer membrane or have a natural therapeutic purpose. Many molecules or ions will spread and or diffuse from where they are more concentrated to where they are less concentrated until they are equally distributed in that cellular space, a passive transport.

Small molecule drugs widely disburse and may target all cell types, have multiple side effects, and many may not be able to travel to the cell or correctly influence extracellular pathways adequately. The Ion Biotechnology® Aqua Ligands ” IBAL ” provides a polarized active transport across cell membranes. The osmotic pressure of water (hexaaqua ligand) creates dispersion of free ions facilitated by polarity and size (small molecular weight) in the interstitial fluids directly through the membrane’s lipid bilayer and into the membrane cytoplasm within the cell, as a natural active transport.

The Ion Biotechnology® Aqueous Ligands (IBAL) has been manufactured and researched in these completed complexes obtaining pH levels, Redox values (ORP), and Metal cation ratios described in the invention. ION-ZC1 for research, ION-ZCM1 as an API candidate in a drug master file, and Ion Gel ZCM-25® as a medical device and drug candidate.

Multiple in-vitro, in-vivo, and preclinical animal and human trials have been performed, supporting the IBAL safety, components, efficacy, and modes of action in biological systems.

Anticancer Modes of Action

One of the IBAL modes of action targets cancer cells by apoptosis. Clinical studies on several human cancer cell types have used the cell’s natural death mechanism as an anticancer therapy. Treating the biological system to enhance apoptosis’s natural function to prevent cancer is one of the main functions. Animal studies of IBAL exhibit anticancer activity by activating the apoptotic pathway.

Exploiting the natural mechanisms for cell death is a highly effective method of treatment. Drugs targeting apoptosis are some of the most successful non-surgical therapies. Some have proven efficacy in all cancer cells as apoptosis evasion is a cancer hallmark, but they come with the cost of high cytotoxicity. IBAL creates apoptotic signals in several forms, cationic metal delivery, Zn/Cu SOD, redox signaling, and reduction of free radicals. All MoAs contribute to change the tumor environment through death ligands of IBAL in the extrinsic pathways creating extracellular signals to induce apoptosis. As a secondary MoA in the intrinsic pathway, death-inducing signals produced by cytotoxic T cells from the immune system respond to damaged, infected, or mutated cells.

Cancer cells switch their metabolism to glycolysis to meet their energy requirements, known as the Warburg effect. One of the anticancer MoA’s of IBAL exploits the Warburg effect to push the cancer cell further into the cellular respiration process to create an apoptotic death.

Using the specific natural components (nutritional metals) in an IBAL compound lowers the toxicity levels seen in current drug treatments. Multiple administration methods and dosing levels provide:

A spectrum of safety profiles that target tumor environments.

Tumor areas in all age groups.

Concurrent treatments.

Antimicrobial Modes of Action

Several studies support the antimicrobial efficacy of IBAL compounds ION-ZC1, ION-ZCM1, and Ion Gel ZCM-25®. Similar metal ions and details of the compounds determine several modes of action that are increased and decreased based on each therapeutic use’s administration method and dosing.

Anaerobic cells experience cytosolic metal intoxication from the overload of natural metal cations in IBAL, causing necrotic and or apoptotic (programmed) cell death.

This method of cell death triggers several immune responses in biological systems. The aerobic cells’ non-toxic essential metal (nutrients) uptake during cellular respiration and apoptotic cell death for the anaerobic cells creates an environment that prevents the adverse cascading events toward disease.

Studies on IBAL formulations described in this invention have supported the preventative claims.

Redox Signaling – RSS – RNS – ROS Modes of Action

Redox balance is the underlying chemical mechanism for all biological processes. Biological homeostasis is created, regulated, and sustained by reduction-oxidation (redox code) reactions that drive photosynthesis, respiration, and most reactions in between for all biological systems to function. A redox system consisting of chemical interactions of one or all of the following; Reactive Oxygen Species (ROS), Reactive Nitrogen Species (RNS), and Reactive Sulfur Species (RSS), are key to the manipulation of many biological mechanisms to restore normal biological function.

IBAL lab analysis confirms the presence of these elements potentially involved in the redox signaling processes in metabolic pathways and intermediates in the Oxygen, Nitrogen, and Sulfur reactive species of biological systems.

Reactive Oxygen Species – ROS

Cationic Hydrogen (H+ (aq)) as an electron donor (reduction) for hydroxyl radical (HO•) or radical oxygen (O2-), also known as oxidative stress, cell aging (telomere length), and DNA methylation.

Reactive Nitrogen Species – RNS

Cationic metal Ammine complex (NH4+ (aq)) as an electron donor for nitrogen reduction and or acting as an ammonia (NH3) ligand in triggering glutamate production used in amino acid synthesis.

Reactive Sulfur Species – RSS

Anionic Sulfur (HSO4- (aq)) triggers redox switches and redox relays. Sulfur is considered as part of cellular antioxidant systems, and there is mounting evidence that RSS has stressor properties similar to the ones found in ROS but are formed under conditions as a separate class of oxidative stressors.

These reactive species provide multiple cell signaling pathways, redox systems, and electron transfers for homeostasis. IBAL developed compounds deliver high levels of H+, such as done with the ION-ZC1, ION-ZCM1 having a pH below 1.0 carrying H+ in a Zn2+ Cu2+ SOD ligand. There are many unknown beneficial potentials for Ion Biotechnology® based on the processes and relationships with ROS, RNS, RSS, and the interactions of NOx, H2S, and O2 and derived species. The core components of IBAL formulations, NH3 + HSO4- + H+, influence each of the above species by chemical mechanism, electron transferring, or biological processes.

Prevention

Minerals are naturally occurring chemical compounds of elements required as essential nutrients by organisms to perform functions necessary for life. Metals have played an essential role in biological systems from the beginning of time.

As catalytic or structural cofactors, metal ions are critical to the function of up to an estimated one-third of all enzymes and have extensive roles in biological systems.

The invention brings chemistry and biology an interface to help solve current approaches’ inability to create and deliver biological homeostasis.

Natural forms of SOD and their delivery method are difficult to manufacture, hard to reproduce, and expensive.

In contrast, IBAL artificial SOD can be produced in large quantities and utilized in several application technologies such as creams, injectables, transdermal patches, inhalers, and other administration methods currently used by health practitioners.

IBAL compounds in SOD forms can be further developed with Manganese Mn2+ SOD and Iron Fe2+ SOD as ionic metals in addition to the Zn2+ Cu2+ SOD.