Most Potent Anti-Fatigue Compound Ever Discovered

Re-printed from Allergy Research Group Newsletter February 2004

See Additional Newsletter Articles on COBAT

• Homepathic Proving
• Animal Case Studies

Article Index

• Immune Modulation
• Animal Models
• Reduced Fatigue
• Reduced Fatigue-Case Studies
• Reduced Fatigue- Case Studies HCV
• Informal Trials
• Safety

Taurox SB™ 6X Enhanced – formerly named “COBAT” – A Compound with Novel Mechanisms of Action Emerges from Nanotechnology

(Taurox SB™ 6X Enhanced) “COBAT” is carbobenzoxy beta-alanyl-taurine, a covalent chemical combination of taurine and beta-alanine that has been modified to be efficiently absorbed via the oral mucosa. It has a molecular weight of 724. Reports at scientific meetings (Whole Person Healing Conference) document COBAT to be effective in reversing fatigue (see graphs pages 4-6) in patients with chronic fatigue, hepatitis C and cancer. The effective dose of COBAT is very low, in the nanogram level making it, in our opinion, the most potent and powerful general use anti-fatigue element ever discovered. In a small clinical trial, COBAT was found to be effective for reducing fatigue in approximately 90% of patients with chronic fatigue, hepatitis C and cancer. The compound is so powerful and used in such small amounts that it is considered a "nano" compound from the concept of nano technology, and when compared to other more commonly known anti-fatigue elements, it is consistently more than one thousand to one million times more potent by weight. The mechanism of action is definitely non-adrenergic; it modulates the immune system and is anticipated to be complementary to large molecules (beta glucans, mush-room extracts, etc.).

Cytokines Modulate Fatigue

It has been known that cytokines can strongly modulate fatigue. For example, interferon-alpha (IFN-alpha), interleukin-2 (IL-2), or tumor necrosis factor (TNF) have been used to treat cancer or hepatitis, and they typically cause a "cytokine syndrome" of fatigue, fever, brain fog, myalgia and depression. Such symptoms are similar to those that naturally occur in these and other severe illnesses, hence these symptoms may be related to the cytokines involved. An immune system response that is less than optimum may result in cytokine imbalances – this is the fatigue or “cytokine syndrome”.

IMMUNE MODULATION

COBAT is thought to potentate the immune response in T cells as well as decrease tumor growth. Dunn, et al. examined the ability of COBAT to modulate the immune system as detected by activation markers, second messenger cascades, proliferation, and cytokine production, as well as in vitro T cell cytotoxicity. The results of these studies gave insight into the potential mechanism of action of COBAT as an immunostimulatory anticancer agent. (See Table 1 below by Dunn, et al.)

TABLE 1: Summary of The Immunomodulation Effects of COBAT (by Dunn, et al.)

POTENT IMMUNE MODULATION

Tom Dunn at the University of Maryland, College Park, performed numerous pharmacological experiments on COBAT, finding it to be a potent immune stimulant for human cells. The increase in T-cell calcium flux, which occurred at very low doses, and other immune function increases (see Table 1, pg. 2) induced by COBAT suggested that stimulation of T cells might contribute to its anti-tumor activity.

COBAT enhanced components of early T cell activation, including increased up regulated expression of the CD69 T cell activation marker and enhanced proliferation of blood peripheral mononuclear (immune) cells in culture. T u m o r necrosis factor alpha (TNF-alpha) and interferon gamma message RNA and protein were also up regulated in the presence of COBAT. This up regulation was seen unless the cells were also exposed to excess levels of exogenous stimulation, in which case a normalization of some abnormally high values were seen. Thus COBAT is best referred to as an immunomodulator, as opposed to an immunostimulator; it appears to produce a normalization or “adaptogenic” response.

COBAT enhanced granzyme (esterase-containing killing granules) in T cells, and also enhanced expression of cell surface TNFa. This arming of lymphocytes with TNFa on the surface was accompanied by a decrease or no change in the amount of secreted TNFa. Secreted TNFa may be associated with systemic toxic effects. While surface TNF may provide significant benefits without toxicity, Dunn et al. reported that the increased presence of surface TNFa, mediated by COBAT , was able to effect the killing of HL60 tumor cells in vitro. The in vivo anti-tumor mechanism of action of COBAT may be through T cell activation in a calcium-dependent manner, leading to increased TNFa arming on the surface of immune cells. The researchers also found similar arming of monocytes.

The key factor that initiates the action of COBAT may be the change in calcium flux it induces. This is a primary activation signal for immune cells which lead to an amplifying cascade of immune stimulation under the appropriate conditions. This phenomenon was observed at very low (nanomolar) doses. Dunn suggested that COBAT may help keep the immune system active in the elderly, as it is believed by some that diminished calcium response is a factor in lowered T cell activity in older persons. The action of COBAT is achieved at lower doses in vivo than in vitro. The ability of nanomolar doses (one trillionth of a mole) of COBAT to alter calcium flux in vitro is noteworthy.

ANIMAL MODELS

COBAT was shown to exhibit anticancer effects in animals. It was shown to have potent anti-tumor effects against melanoma and myeloma in animals at extremely low doses with negligible toxicity. The compound was also tested in several animal models in which it stimulated immune function and had extremely potent anticancer activity. (See Table 2 below)

TABLE 2: Animal Models of COBAT Activity

REDUCED FATIGUE

The Immunomodulator COBAT Reduces Fatigue in Patients with Cancer, HCV and Chronic Fatigue Syndrome
Mayerson, S.E. and Taub, F.E.

Late Breaking Presentation at the First International Conference on Whole Person Healing, Bethesda, MD, March 28, 2003.

ACKNOWLEDGEMENT: The participating clinicians (in alphabetical order) included: Toni Bark, M.D.; Franne Berez, M.D.; Zidi Berger, M.D., N.D.; Burt Feldman, M.D.; Mitchell Fleisher, M.D.; Terri I. Gilbert, N.D.; David Riley, M.D.; Tedde M. Rinker, M.D.; and David Servan-Schreiber, M.D.

Reduced Fatigue Case Studies

In the studies represented in the graphs on pages 4-6, all but 1 out of 16 patients experienced a reduction in fatigue. 52% was the average improvement. Significant test for pre-post scores (p=.000002). See below for summaries from 5 of the 16 participants.

A 49-year-old male entered the study with Chronic Fatigue Syndrome (CFS), fibromyalgia, allergies and oral herpes. He took the COBAT dose for about 2 months. He reported increased energy, no new eruptions of herpes and one cold that resolved more quickly than usual. He noted some decrease in frequency of allergy and fibromyalgia symptoms.

A 39-year-old female with breast cancer and melanoma entered the study for fatigue and PMS. She reported greater energy and better sleep.

A 57 - year old female with arthritis and Irritable Bowel Syndrome (IBS) reported less fatigue and improvement in IBS.

A 46 year old female with severe CFS and numerous other conditions, including IBS, report-ed less fatigue and great improvement in her IBS.

A middle-aged female with HCV, fatigue, and other severe symptoms now wakes up without feeling "like a train wreck".

Reduced Fatigue Case Studies (HCV)

The following are summaries of HCV patients who experienced decreased fatigue on the COBAT formula. The graphs show changes in fatigue over time for various patients. The only intervention given to these patients was COBAT. It was administered without nutritional or other changes in patient activities.

A female patient experienced improvement with memory, depression, headaches, and allergies. Another patient experienced less pain and fewer GI symptoms.

A middle-aged female with Hepatitis C virus (genotype 1) entered the study due to fatigue. In 1999, she had failed interferon alpha (IFN) therapy after an initial good response. IFN caused severe debilitating side effects while providing only temporary stoppage of viral proliferation. She took the COBAT formula for 4 months. Her viral load decreased by about 40% on average, with a maximal decrease of 62%. She also reported less fatigue on both doses. Her previously required daily naps became unnecessary throughout the trial period. After she completed the trial and stopped taking the COBAT formula, she frequently required lengthy daily naps.

Several patients with HCV also entered the trials with elevated liver enzymes, all of which, decreased to normal during the trial. These findings are considered interesting and support the hypothesis that decreased fatigue is associated with changes in the immune system and decreased liver damage. While the decrease in fatigue was documented, additional studies are needed to document decreased damage to the liver.

Informal Trials
5 of 5 Respond!

In an informal trial done by one of the editors on himself and 4 others (friends & co-workers) with mild fatigue, all experienced complete resolution of fatigue in a very short period of time. Below are what they had to say about COBAT:

Stephen Levine, Ph.D.:
“I found personally that COBAT eliminated my long-standing early morning fatigue presumably due to adrenal weakness.”

Diane Raile, CNC (ARG Clinical Nutritionist):
“Ten years ago I experienced the onset of Fibromyalgia, including extreme overall body pain leading to chronic fatigue and depression. For three years of that time I was almost completely non-functional and living on disability. I have spent these past ten years with my main priority being, regaining my health. I have done a variety of only non-allopathic methods and treatments to identify and address the factors involved in my ill -ness, many of which have been successful. Despite my success, I have felt that my "core", for lack of a better description was still weak and fragile. Up until October, 2003 (when I began taking COBAT), I still found it necessary to sleep as many as 12 to 14 hours a day, several days a month, or often an entire weekend, just to be able to function. Five days after taking 15 drops of COBAT each morning upon waking, I awoke feeling like a completely different person. I could feel that my "core" was much stronger and that something had definitely shifted. I can't explain it but this much deeper than just adrenals or mitochondria.”

Dixie Raile (Diane's twin sister):
“After a severe shoulder injury and a somewhat unsuccessful surgery and rehabilitation, I have suffered from chronic pain. I start -ed into college, and with the hours of studying and writing, the pain became unbearable. I have never responded well to pharmaceutical medications so there was nothing I could take. I wasn't sleeping well and between that and the stress of the whole ordeal I was loosing ground fast. I was tired and depressed and ready to give up. I tried COBAT and after 2 weeks I started waking up feeling refreshed and had a better ability to concentrate. My attitude began to improve which improved my experience of pain. I continue to take it everyday. It seems like I have a solid foundation under me now; I'm more able to handle stressful situations without falling apart and when I do fall apart, it doesn't last as long.”

Claude Larson:
“COBAT is great. It's very subtle, yet unmistakably effective. It creates no buzz or edginess, yet it provides energy for both physical and mental work. It has allowed me to stop drinking caffeinated coffee for the first time in my adult life."

Robbin Larson:
“Wow -when I began taking COBAT, I started with only a few drops. I was amazed at the boost of energy from such a low dose. It was very pleasant, not at all jittery as from caffeine, and it lasted throughout the work day. Being menopausal, I found that it decreased brain fog and increased my mental clarity. At the end of the day, the quality of rest was also noticeable. I slept soundly and awoke refreshed and relaxed“

Safety

Specific toxicology studies of COBAT suggest that it has an unusually wide margin of safety between the effective dose and the amount of material that can be harmful. Acute toxicology studies conducted by Midlantic Bio-Research on COBAT in adult male and female CD-1 mice suggested a maximally tolerated dose (MTD) of about 133 mg/kg administered as a single intravenous bolus. A similar finding was obtained with rats. Thus, the toxic dose levels of the compound appear high. The 6x strength of oral homeopathic COBAT dosing is about one billion fold lower than this level. Studies of oral COBAT (Product Safety Labs) found that rats tolerated 2000 mg/kg daily for 14 days without adverse effects. Water intoxication would prevent a person from ingesting sufficient amounts of the preparation to receive even one ten thousandth of the amount of COBAT anticipated to be toxic.

In a GLP (FDA-suitable good laboratory practices) study in rats, no toxic side effects were observed following either oral or subcutaneous 400 mcg/kg doses of COBAT given daily. During the 14-day post-administration period, the animals all gained the appropriate amount of weight as compared to saline-injected controls and there was no morbidity or mortality. Following euthanasia, there were no abnormal findings in the gross necropsies.

From human experience, we see that any material given in sufficiently low doses, below the toxic animal dose, will also be non-toxic in humans. Environmentalists and toxicologists consider that the low dose of 1/100,000 th of a compound's toxic dose is so safe that it can be labeled as virtually non-toxic or virtually safe and does not need further analysis.

Questions about the COBAT formula? Contact our Technical Support Department at: 800-545-9960

Focus on Allergy Research Group ® Editor-in-Chief: Stephen A. Levine, Ph.D.

Managing Editor: Elise Zurlo, CNC

Medical Editor: Jeffry L. Anderson, M.D.

Assistant Copy Editors: Diane Raile, CNC & Luba Voloshko, Ph.D.

FOCUS is published to provide scientific information to healthcare practitioners and physicians. Certain persons considered to be experts may disagree with one or more of the foregoing statements concerning relationships of various nutritional factors to structures and functions of the body, or various nutritional situations adjunctive to certain bodily conditions. The same are deemed, nevertheless, to be based on sound and reliable authorities. No such statements shall be construed as claims or representations that any Allergy Research Group®/NutriCology®, Inc. products, which are dietary supplements, are offered for the diagnosis, cure, mitigation, treatment, or prevention of any disease.

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