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Introduction to Immunotherapy

Immunotherapy presents a number of potential advantages over approved treatments for cancer, infectious diseases, and autoimmune diseases. The traditional tools for treating cancer have been around for many years: surgery for several centuries, radiation since the late 1800s, and chemotherapy evolved in the 1950s from the use mustard gas after World War I. All of these treatments are based upon removing visible tumors, or involve destroying the cells, either by damaging their DNA or other forms of selective toxicity. All of these therapies have a high degree of substantial side effects. Analogously, antibiotics, anti-viral drugs, and drugs or biologics for autoimmune diseases have limitations in efficacy and are associated with substantial side effects. The goal of immunotherapy is to make a greater impact on these diseases, either by itself or as a complement to conventional therapies, without causing major side effects.

The immune system is complex and diverse with three major biological functions:

  1. 1.Immune defense against infectious organisms such as bacteria, viruses, fungi, parasites;
  2. 2.Immune homeostasis which works to remove senescent cells and debris;
  3. 3.Immune surveillance to recognize and eliminate mutated or malignant cells.

Researchers discovered that the principal cells in the immune system that attack infectious organisms and cancers are macrophages, dendriticcells, T cells, NK cells, NKT cells, gamma/delta T cells, B cells, and granulocytes. These cells originate in bone marrow and play functions in peripheral blood, immune organs, and almost all organs and tissues in the body.

The most important effectors of an immune response are a class of white blood cells known as lymphocytes. These cells develop in the bone marrow and are released into general circulation and from there, they can respond to danger signals and proteins called chemokines and home to sites of infection or abnormal cells. There are three subpopulations of T Cells: Helper T Cells (Th) (CD4+), CytotoxicT Cells (CTL)(CD8+) and CD4+CD25+T cells (Tregs). In addition, NK cells and NK-T cells are natural responders that can deal with foreign cells or invaders early, before the development of a specific T cell response.

One of the most significant medical advances in the past forty years is the discovery of a progressively increasing number of hormones of the immune system, known as "cytokines.” Cytokines are small proteins or polypeptides produced mainly by certain immune cells that interact with other cells of the immune system in order to regulate the body's response to disease or other disorder.

The most famous of these are the interleukins (IL) and the interferons (IFN), such as IL-2 and alpha and gamma IFN. Another major group includes the enkephalins, such as methionine met-enkephalin (MENK), and endorphins that are produced by brain and endocrine cells as well as immune cells, and regulate not only the cells of the immune system but also those of the brain and the endocrine system, keeping the two in balance. Clinically, these cytokines have been found to be useful in stimulating the immune system and in treating viral infections such as HIV/AIDS, hepatitis as well as in numerous types of cancers.

MENK, the endogenous neuropeptide generated in the adrenal gland and derived from proenkephalin is suggested to be involved in the regulatory loop between the immune and neuroendocrine systems, with modulation of various functions of cells related to both innate and adaptive immune systems.

Two of the most important compounds to come out the current research for TNIB are LDN (Low Dose Naltrexone) and MENK (methionine-enkephalin). They have the ability to boost or restore the immune system by increasing the T and NK cells in the body, thereby activating its own natural defenses.

The TNI BioTech, Inc. scientists have published innovative articles showing that MENK plays a very important role in immune restoration in 28 cancer patients, and that MENK showed more advantages in boosting the human immune system than either IFN gamma or IL-2, especially noting that MENK inhibits Treg cells while IFN gamma or IL-2 did not, which is a unique discovery of TNI BioTech, Inc. and supports our major strategy to combat cancer and HIV/AIDS with MENK.