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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.
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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.
Related Articles
Thymic
Protein A: Cell-mediated immunity
Dr.
Terry Beardsley on Thymic Protein A
My
experience with Thymic Protein A
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