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Last updated January 1, 2014

The Thymic Protein A Story

The discovery of a remarkable immune system regulator

The Beginnings
The discovery and development of Thymic Protein A began, as do many breakthroughs, with the pioneering work of others. The function of the thymus gland was only first understood in the early 1960's when Dr. J.F.A.P. Miller experimented on animals by removing their thymus gland, and observed that they proceeded to develop profound, life-threatening immune deficiency. Subsequently, Doctors Osoba and Miller, along with Dr. Esther Hays, demonstrated that certain soluble factors from the thymus, when administered to animals, could restore the lost immune function from removal of their thymus gland.

Photo of Dr. Terry Beardsley. In the late 1960's Drs. Goldstein and White were able to extract and biochemically isolate a portion of calf thymus which they named "thymosin fraction 5" and which contained a mixture of more than 30 peptides. This thymic fraction was able to stimulate a very limited immune response; however its success was limited, due to its fragmented nature and the fact that the complexity of this mixture created competing biological activity, thus diluting the effectiveness. However, this discovery sowed the seeds from which later emerged the discovery of Thymic Protein A.

Dr. Terry Beardsley's Discovery
In the early 1970's while working with immune deficiency models as a doctoral student at Baylor College of Medicine, Dr. Terry Beardsley attempted to improve the immunity of the same animal models with thymosin fraction 5. He obtained the same minimal and transient results as did the original researchers, but in working with his model, Dr. Beardsley realized that if he could obtain the cells that produce the mixture of regulatory proteins directly from the thymus, they would provide a continuous source of pure native biomolecules, rather than just an extracted portion. After completing his Ph.D. program, Dr. Beardsley moved to UCLA to work with Professor Esther Hays, M.D., one of the world experts in knowledge of thymic function.

Eight years of Hard Work Yield Important Results
At that time, no one had ever established continuously growing thymic stromal cells (the cells that produce the immune regulating substances) in a laboratory. Through a mixture of persistence and serendipity, Dr. Beardsley succeeded in establishing several cultures of thymic stromal cells directly from a thymus. Most of these consisted of mixed cultures with a variety of cell types, producing a myriad of peptide fractions. Although this mixture did possess some immune stimulatory activity at higher levels than the previously known cultures, the results were confused and weakened by the presence of several competing biological activities. The only way to find out which cells were useful in immune activity was to clone each cell type, a formidable task which took Dr. Beardsley 8 years to complete by a tedious method involving placing a single cell in a petri dish and growing it into millions of cells. To get a single cell type to replicate involved interaction from other cell types, Dr. Beardsley discovered that a single purified protein called epidermal growth factor (EGF) stimulated the growth of the single thymic epithelial cells in the petri dish. After 8 years, and exhaustive testing, Dr. Beardsley was able to identify one particular fraction, fraction A, which he named Thymic Protein A (TPA), which contained 500 amino acids and comprised a complete protein. TPA alone produced all the major immune activity of the entire thymic mixed cultures that Beardsley had started with, but without the presence of any of the other cell types. In this manner, Beardsley produced the first single complete thymic protein biomolecule, in its native state, with potent immune activity.

The next step was to understand the biological mechanism of action of this protein. It was demonstrated in a number of animal models of virus infection that TPA acts as an immune regulator, activates the CD4 lymphocyte (T-4 helper cell), and enhances the development of specific cytotoxic T killer cells that destroy infected cells.

Clinical Animal Experiments
After the basic science was established and a pure single entity was reliably reproduced in quantity (the gold standard in clinical immunology research), clinical experiments with animals were continued in several areas. The first large-scale tests were performed by an animal health company that wanted to improve their existing rabies vaccine. This company had already spent over $150,000 testing thymosin fraction 5, with negative results. When they added a tiny amount of Thymic Protein A to their vaccine, its potency was increased by 2.5 times. In a test of dogs with distemper (rabies), 6 of 7 dogs treated with the vaccine fortified with Thymic Protein A survived, compared with 3 of 7 other dogs with distemper treated with the normal strength vaccine.

Another clinical validation of TPA was as an immuno-therapeutic for cats with feline AIDS, a disease similar to human AIDS for which there is no treatment. In a Phase II field study in 22 cats with feline AIDS, significant increases in lymphocyte counts were observed, as well as remarkable improvement in clinical well-being, including resolution of life-threatening infections. Approval for use with animals is pending with the United States Dept. of Agriculture.

The New Oral Formulation
Based upon the animal studies a Phase I human clinical study was conducted by a major AIDS advocacy group, with 4 of 6 patients responding favorably. Concurrently with the above-mentioned clinical studies with the injectable thymic protein A, Dr. Beardsley began testing the protein in a unique oral formulation which avoided the degradation of protein in the stomach, a significant problem which occurs with other over-the-counter thymic oral preparations. Initial experiments in mice and dogs confirmed that Thymic Protein A was active in this unique oral form. Lymphocyte counts and cell-mediated immunity to viral infections were significantly increased. Human testing confirmed these results. All of these scientific data resulted in a U.S. Patent being awarded to Dr. Beardsley in 1997 for both the Thymic Protein A molecule and the method of its production.

Over the past five and a half years since Thymic Protein A was introduced as an oral nutritional supplement, several human studies have further substantiated the scientific findings that this protein alone, in its purified state, has tremendous immune regulation capability--as both a stimulant and a down-regulating agent, depending on the body's requirements. Two studies involving chronic fatigue syndrome (CFIDS) have shown improvements both clinically and by diagnosis testing in both CFIDS and Epstein-Barr (EBV) patients. Most significantly, this enhanced immunity is produced at microgram doses (generally 4-12 micrograms daily). Thousands of individuals have consumed this product, and hundreds of medical doctors are using it for a variety of immune-related illnesses with no adverse reactions from this highly purified, extremely safe, low-dose protein molecule. Thymic Protein A is produced at only one site in the entire world, under the personal control and supervision of Dr. Beardsley, who is committed to maintaining the high scientific standards which he established in the research and manufacture of this product over the past 25 years. Future studies, already in progress, will expand the range of applications of this scientifically proven product.

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