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In Focus

NutriCology® Newsletter

March 2004

Most Potent Anti-Fatigue Compound Ever Discovered

In This Issue

Most Powerful AntiFatigue Compound Ever Discovered . . . . . . . . . . 1 Understanding Cellular Immunity . . . . . . . . . . . 2 Immune Modulation . . . 3 Reduced Fatigue . . . . . 4 Informal Trials . . . . . . . 6 Safety . . . . . . . . . . . . . 6 Homeopathic Proving Trial . . . . . . . . . . . . . . . 7 Commentary from Floyd Taub, M.D. . . . . . . . . . . 8 Cytokines Regulate Sleep and Fatigue by Daniel Rubin, N.D., and Stephen Levine, Ph.D. . . . . . . . . 9 Animal Case Studies: Clear Improvement in Quality of Life . . . . . . .12

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New "COBAT" Compound Emerges from Nanotechnology

"COBAT" is carbobenzoxy beta-alanyl-taurine, an amino acid derivative combination of taurine and beta-alanine that has been modified to be efficiently absorbed via the oral mucosa. Reports at scientific meetings (Whole Person Healing Conference) document COBAT to be effective in reversing fatigue (see graphs pages 4-5) in patients with chronic fatigue caused by a wide array of health conditions. 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 regardless of the cause of their fatigue. The compound is so powerful and used in such small amounts that it is considered a "nano" compound from the concept of nanotechnology, and when compared to other more commonly known anti-fatigue agents, it is consistently more than one thousand to one million times more potent by weight. COBAT modulates the immune system and is anticipated to be complementary to large molecules (beta-glucans, mushroom 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".

Understanding Cellular Immunity

a complex network of specialized organs, cells and cell products that protect the body from bacteria, viruses, infections, and other substances that the body recognizes as foreign invaders. These "invaders" are normally controlled by the body, but under certain circumstances, may lead to tissue injury due to failure or dysfunction of the immune system. It is important to understand how the immune system defends the body and how cellular immunity is involved in this protection. Some of the key players involved in cellular immune regulation are manufactured by the thymus gland and are generally known as T-cells. However, there are several types of T-cells including: T-helper 1 (Th1), Thelper 2 (Th2), T-suppressor 1 (Ts1), and T-suppres-

The immune system is

sor 2 (Ts2). Lymphokines and cytokines are immune cells that are produced by the various T-cells. Cytokines Regulate the Immune System During an immune system response, the various Tcells communicate with one another to coordinate the identification and destruction of foreign invaders (infections, etc.). Most of the cells of the immune system secrete cytokines, and each cell type produces a distinct set of cytokines. Mounting evidence suggests that many diseases and health conditions may be classified as either Th1 or Th2 cytokine profiles. For example, multiple sclerosis, type I diabetes, and arthritis are all considered Th1 phenotypes, while allergy, chemical sensitivity, parasitic infection, and lupus are considered Th2 phenotypes.

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In Focus March 2004

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COBAT: Potent Immune Modulation

Immune Stimulation v. Immune Modulation

Immune stimulation occurs when an agent, natural or chemical, stimulates the immune system by increasing the strength of the immune cells' response and/or increasing the number of immune cells produced. Immune modulation occurs when an agent, natural or chemical, regulates the immune response and/or number of immune cells produced. Immune modulation has a balancing effect on the immune system by selectively stimulating or regulating cells that are underactive and/or underproduced and regulating immune cells that are overactive and/or overproduced. Substances that modulate the immune system are also referred to as "adaptogenic." human cells. The increase in T-cell calcium flux, which occurred at very low doses, and other immune function increases were demonstrated. COBAT enhanced components of early T-cell activation, including increased upregulated expression of the CD69 T-cell activation marker and enhanced proliferation of blood peripheral mononuclear (immune) cells in culture. Tumor Necrosis Factor-alpha (TNF-alpha) and interferongamma message RNA and protein were also upregulated in the presence of COBAT. This upregulation was seen unless the cells were also exposed to excess levels of other stimuli, in which case a normalization of some abnormally high values was seen. Thus COBAT is best referred to as an immunomodulator, as opposed to an immunostimulator; it appears to produce a normalization or "adaptogenic" response. 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 leads to an amplifying cascade of immune stimulation under the appropriate conditions. This phenomenon was observed at very low (nanomolar) doses. The researchers 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.

COBAT: Potent Immune Modulator

COBAT is thought to modulate the immune response via Tcells. Researchers have examined the ability of COBAT to modulate the immune system as detected by immune activation markers, immune cell proliferation, and cytokine production. The results of these studies gave insight into the potential mechanism of action of COBAT as an immunomodulatory agent. Researchers at the University of Maryland, College Park, performed numerous pharmacological experiments on COBAT, finding it to be a potent immune modulator for

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REDUCED FAT I G U E

The Immunomodulator COBAT Reduces Fatigue in Patients with Chronic Fatigue Syndrome & Other Health Conditions

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 with a significant t-test for pre-post scores (p=.000002). See below for summaries from 5 of the 16 participants.

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

s

s

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In Focus March 2004

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REDUCED FAT I G U E

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.

s Afemale patient experienced improvement with memory, depression, headaches, and allergies.

Another patient experienced less pain and fewer GI symptoms.

s

A middle-aged female with Hepatitis C virus (genotype 1) entered the study due to fatigue. In 1999, she had failed interferon-alpha (IFN-alpha) 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.

s

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Informal Trials

strengthening, increased energy and well-being feels much deeper than just adrenals or mitochondria."

Dixie Raile (Diane's twin sister): "After a severe shoul der 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 writ ing, the pain became unbearable. I have never responded well to pharmaceutical medications so there was noth Stephen Levine, Ph.D.: "I found personally that COBAT ing I could take. I wasn't sleeping well and between that eliminated my long-standing early morning fatigue pre - and the stress of the whole ordeal I was loosing ground fast. I was tired and depressed and ready to give up. I sumably due to adrenal weakness." tried COBAT and after 2 weeks I started waking up feel Diane Raile, CNC (ARG Clinical Nutritionist): ing refreshed and had a better ability to concentrate. My "Ten years ago I experienced the onset of fibromyalgia, attitude began to improve which improved my experi including extreme overall body pain leading to chronic ence of pain. I continue to take it everyday. It seems like fatigue and depression. For three years of that time I I have a solid foundation under me now; I'm more able was almost completely non-functional and living on to handle stressful situations without falling apart and disability. I have spent these past ten years with my when I do fall apart, it doesn't last as long." main priority being, regaining my health. I have done a Claude Larson: "COBAT is great. It's very subtle, yet variety of only non-allopathic methods and treatments unmistakably effective. It creates no buzz or edginess, to identify and address the factors involved in my ill yet it provides energy for both physical and mental ness, many of which have been successful. Despite my work. It has allowed me to stop drinking caffeinated success, I have felt that my "core", for lack of a better coffee for the first time in my adult life." description, was still weak and fragile. Up until October, 2003 (when I began taking COBAT), I still Robbin Larson: "Wow! When I began taking COBAT, I found it necessary to sleep as many as 12 to 14 hours a started with only a few drops. I was amazed at the boost day, several days a month, or often an entire weekend, of energy from such a low dose. It was very pleasant, not just to be able to function. Five days after taking 15 at all jittery as from caffeine, and it lasted throughout drops of COBAT each morning upon waking, I awoke the work day. Being menopausal, I found that it feeling like a completely different person. I could feel decreased brain fog and increased my mental clarity. At that my "core" was much stronger and that something the end of the day, the quality of rest was also noticeable. had definitely shifted. I can't explain it but this I slept soundly and awoke refreshed and relaxed." 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:

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 appears 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

Safety

preparation to receive even one ten thousandth of the amount of COBAT anticipated to be toxic. In a GLP (FDAsuitable 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 salineinjected 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 1/100,000th of a compound's toxic dose is so safe that it can be labeled as vir-

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In Focus March 2004

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

Homeopathic Proving Trial

In March of 2001, a total of 39 volunteers completed the first homeopathic proving trial for COBAT. COBAT was prepared according to GMP homeopathic standards by Eric Foxman at Hauser, Inc. It was diluted via a series of six ten-fold dilution steps with vigorous agitation (succussion) at each step. The final steps were in 20% EtOH to prevent microbial growth. COBAT is prepared by the classic homeopathic methods of dilution and vigorous mixing at each step. COBAT is considered a homeopathic medicine and has entered that regulatory path. Documentation of COBAT as a homeopathic medicine has been made by a variety of experts under "Rule of 3" of the

"Of all the homeopathic provings I have been involved with (35 trials) COBAT produced the strongest effects." David Riley, M.D. "The results of the homeopathic proving trial suggest that it might be involved in a wide variety of immune related conditions. These should be studied in the future" Floyd Taub, M.D.

The homeopathic proving trial was a double-blind, placebo trial which evaluated 6x and 8x doses. An apparent physiological effect was observed in 26% of patients given the placebo. 92% (overall for 6x and 8x) receiving COBAT were identified as having physiological effects. Dr. Riley's report of the essential characteristics of Materia Medica (i.e. those symptoms that may be according to the law of similars, either caused or resolved if previously present) are shown here:

Materia Medica

Essential Characteristics of Symptoms (by Riley): Allergies Appetite Abnormalities Colds Coughs Headaches Increasing Energy Irritable Bowel Syndrome, Loose stools Muscle aches and Pains Neurological Problems PMS Viruses

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Commentary from Doctor Floyd Taub, M.D.

The "Goldilocks" Effect

Dr. Floyd Taub, M.D., notes that COBAT shows adaptogenic activity at the molecular (mRNA) level, as demonstrated by Pontzer, Dunn and Wormsley. While in unstimulated inactive cells, it increases interferon gamma messages, and thereby has antiviral and antitumor effects. In pharmacologically highly treated cells, it actually dramatically decreased or eliminated the RNA messages for this key Th1 cytokine. Similarly, while it had relatively little effect on secretion of TNF-alpha in unstimulated cells, it virtually eliminated release from pharmacologically stimulated cells (the decrease was over 100 fold). This may be the first molecular data showing an adaptogenic effect. COBAT apparently acts as an immune modulator. It appears to provide just the right amount - the "Goldilocks" effect - not to much, not too little - just the right amount. This balancing of the immune system is further demonstrated by a lack of stimulation of allergic or autoimmune responses. While data on autoimmune disease is sparse, virtually none of the persons with allergies showed an increase. In fact, 60% showed a decrease in allergies. In those that responded, the average decrease was 71%. Most of our patients are fatigued. However, we typically focus on medical therapy to fight the underlying disease. The use of COBAT can be very complimentary to alternative (or conventional) therapies and a major help to patients by relieving much of their fatigue before, during and after* treatment. COBAT clearly improves quality of life. Dr. David Riley, M.D. Dr. David Riley, M.D., stated that his observations during the homeopathic proving trial indicated this was the most powerful homeopathic agent he had tried in over 35 homeopathic provings that he had performed, based on the magnitude of the effects in some patients. This double-blind, placebo controlled trial revealed his clinical sense to be accurate. COBAT-treated persons showed an effect 92% of the time, while placebo-treated patients showed an effect 26% of the time.

*Patients may want to skip COBAT on the day of and day following major cytotoxic therapies to minimize potential damage to the immune system.

COBAT Versus Conventional Drug Therapy for CFS

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In Focus March 2004

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

Cytokines Regulate Sleep and Fatigue

by Daniel Rubin, N.D., Stephen Levine, Ph.D., & Elise Zurlo, CNC

odern day fatigue has gone way beyond being just a signal from the body to go to sleep for the night. Fatigue has seeped its way into daily life, and for many, has become a chronic and debilitating condition - keeping many people from doing the things they love and the things they need to do just to survive. The loss of friends, jobs, and family support and understanding only compounds this devastating condition. Doctors across the coun-

M

try - both traditional and alternative alike, are trying everything to help their patients with chronic fatigue. The problem is, chronic fatigue can be caused by such a wide array of factors that there really is no single way to treat it. Once patients become fatigued, they may also become resistant to treatment for previously unknown reasons. Typically, there are some common root causes of chronic fatigue. Chronic infections of all kinds appear to be a common denominator - systemic fungal (yeast) infections, viral infections, and bacterial infections that just won't go away. Often, antibiotics are not an option for many of these patients because of the diverse nature of the infections and the basic limitations of antibiotic therapy. Lack of complete and restful sleep is another common cause of chronic fatigue and is often linked to what is known as fibromyalgia syndrome. The theory behind it is that there is some derailment in the sleep cycle, so the body never gets fully rested to rejuvenate cells and tissues. This viscous cycle leads to chronic fatigue and loss of integrity of muscle tissue that never has a chance to repair itself - leading to chronic pain and weakness. P ro g ress has been made with emphasis on lifestyle modification, whole foods diets, dietary supplements, clean water and air, stress reduction techniques, and detoxification procedures. However, chronic fatigue appears to have some very deep roots that require digging deeper into the immune system and regulatory mechanisms involved. By

digging deeper, researchers have discovered a whole new world of complexity, which leads us in a very different therapeutic direction beyond the obviously important and currently well known approaches.

Chronic Fatigue Syndrome, Fibromyalgia, Gulf War Syndrome & Cancer Found to Have Similar ImmuneCytokine Patterns

Diverse patients with chronic fatigue exhibit somewhat similar immunecytokine patterns. It is these abberant patterns that may contribute to the treatment-resistant nature of chronic fatigue and other fatiguerelated conditions. Data was presented at the 38th Annual Meeting of AAEM on immune system studies of patients with Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM) and Gulf War Syndrome (GWS) in 2003. Data was reported from a study of 2500 patients, mostly with CFS, some with FM, and some with GWS. The patient groups exhibited surprising similarities in dysregulated immunecytokine patterns. Especially noted was a general switch from a Th1 cytokine pattern to a Th2 cytokine pattern dominance. Gradually, interferon-gamma, natural killer cell activity and phagocyte production were also found to be reduced. Inflammatory cytokines were also elevated, making patients more prone to allergy, hypersensitivity and autoimmunity. This research suggests that the body adapts to these kinds of

Chronic Fatigue

The National Institute of Health describes fatigue as one of the three major symptoms of cancer, and the worst managed of the three. Prescription drugs for this type of fatigue (which is usually caused by anemia) makes up a four billion dollar market in the United States alone. The collective knowledge about fatigue has become large enough that the relationship between biochemistry, infection and fatigue is receiving more attention than ever before. Even with such available knowledge, fatigue is becoming increasingly pervasive in our society.

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CYTOKINES continued

stressors in very specific ways, some of which become maladaptive. The alteration in the immunecytokine patterns appears to be such an adaptation - maladaption is common and similar in these three illnesses, and generally associated with such conditions. In these types of syndromes, it appears that the body is trying to protect itself against overwhelming stress. It's like the body throws a switch - like a light dimmer switch - once this switch is thrown, a common biochemicalimmune-endocrine-inflammation and cytokine pattern is initiated that results in chronic fatigue and pain. This affects other systems of the body such as the hypothalamus/pituitary/adrenal axis, which involves hormonal and nervous system function as well. In addition to addressing the underlying infections, toxicity, and other stressors that initiated these types of syndromes in the first place, it makes sense to correct this negative immune system and cytokine pattern directly. which stands for carbobenzoxy beta-alanyl-taurine, which is the scientific name for the molecules that it contains - amino acid derivatives (amino acids are what protein breaks down to in the body). Some of these peptides are believed to regulate the part of the immune system that controls energy and fatigue. There are a great variety of cytokines. Some cytokines are considered "pro inflammatory". These are the types of cytokines that go into action to fight viruses and cancer. In people with Chronic Fatigue Syndrome, these cytokines may be overactive. Effective antiviral and anticancer control requires the immune system to illicit an initial strong response using these proinflammatory cytokines, and then a prompt return to normal. Instead, it has been observed that people with chronic fatigue, chronic viruses, cancer, and other chronic illnesses tend to have an overstimulation of the pro-inflammatory cytokines that never turn themselves off. Over time, this exhausts the immune system resulting in immune deficiency and fatigue. Research on COBAT suggests it may play a critical role in normalizing some of the abnormal immune-cytokine patterns that have been observed in these types of patients.

Scientific Studies on COBAT

COBAT has been the subject of both animal and human studies, and a pattern of cytokine regulation, as well as a balancing of other immune mediators, appears consistently throughout these studies: 1) In vitro: Researchers at the University of Maryland performed numerous studies on COBAT. They found COBAT to be a potent immune stimulant for human cells. The highlight of this study was that COBAT increased the expression of Cell Surface Tumor Necrosis Factor without increasing Circulating Tumor Necrosis Factor (circulating TNF can produce inflammatory symptoms) so that the increase in membrane or cell surface TNF may help as an active factor in sleep, without increasing inflammatory symptoms. 2) Animal Study: A University of New Mexico study tested COBAT on animals with the cancer myeloma. The results showed an increased survival rate of the animals which ranged from 100% tumor-free to a 66%-75% survival rate, depending on dosage. 3) Human Study: COBAT moderated immune function, appeared to be adaptogenic, and produced physiological changes in patients during a blinded homeopathic proving trial, with a 92% response rate in treated patients and a 26% response rate in controls. In a subsequent University of Southern California study on fatigue in patients whose fatigue was believed to be a result of immune dysregulation, all patients but one, reported a decrease in symptoms. All these effects were highly statistically significant.

COBAT: A New Compound for Fatigue

A new compound has been discovered for fatigue. It's name is COBAT,

Cytokines are small glycoproteins found in femtomolar and picomolar concentrations in the blood, which when bound to their receptors in a hormone-like fashion, elicit certain responses. Cytokines are able to individually elicit such responses but usually work in "groups" to achieve a better overall effect. Almost all biological systems are influenced by cytokines, including the induction of sleep.

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In Focus March 2004

Sleep and Cytokine Regulation

Interestingly, sleep is also regulated by the immune system. Sleep regulation substances (SRS) include: Interleukin (IL-1); b) Tumor Necrosis Factor (TNF); c) Growth Hormone Releasing Hormone; d) Prostaglandin D2; e) Adenosine; and f) Uridine, as well as Prolactin and VIP (Vasoactive Intestinal Peptide). The humoral factors IL-1 and TNF appear to bear the most significance, in that substances that inhibit the production or activity of IL-1 or TNF inhibit sleep altogether. Sites for most SRS appear to be located in the hypothalamus. However there may be other areas of the brain that also participate.

patients' cytokine bias was changed towards a Th1 pattern. We believe that IL-6 plays a central role in the physiological aberrations which contribute to or lead to advanced fatigue states and immune system dysfunctions. Fatigue is enigmatic - it seems to be

Cancer Patients Demonstrate Immune Imbalances Towards Th2 Cytokine Pattern

Interestingly, cancer patients have been shown to have higher levels of IL-6, which is a Th2-inducing cytokine. In fact, not only has elevated IL-6 been correlated with cancer patients, but it also has been shown to play an important role in the progression of some cancers, and has been correlated with cancer-related fatigue. It is also well known among clinicians that cancer patients have deficiencies in cellular immunity. While both Th1 and Th2 cytokine responses may be beneficial against cancer cells, the Th1 pattern is more appropriate in terms of seeking an immune-based recovery from cancer. In fact, it has been shown that many cancer patients who were successfully treated using immunotherapeutic techniques were stuck in a "Th2 rut" prior to their treatment. However, after successful immunological treatment, the

It should be noted that the effects of COBAT may begin immediately, sometimes from the very first dose, or within the first few days, and then progressively increase for months. A therapeutic trial should be one month. Patients who do not respond to a low dose within 34 weeks should be switched to the stronger dose containing more molecules.

other Type 2 cytokines. Regardless of the IL-6 hypothesis, the clinical observation of reduced fatigue and apparently enhanced immune function in the studies is striking. It should be noted that the effects may begin immediately, but progressively increase for months. A therapeutic trial should be one month. Patients who do not respond to a low dose within 3-4 weeks should be switched to the stronger dose containing more molecules. A striking lack of side effects is noteworthy as well. s References available on request.

Daniel Rubin, N.D. In addition to his private consulting practice, in which he specializes in Immunology, Oncology and Integrative Medicine, Dr. Rubin is the Medical Consultant in Oncology and Internal Medicine to the Naturopathic Physicians Board of Medical Examiners in the State of Arizona; Associate Clinical Professor of Naturopathic Medicine at Southwest College of Naturopathic Medicine; Assistant Editor of Integrative Cancer Therapies; Researcher for the Block Center for Integrative Medicine. In addition, Dr. Rubin frequently lectures nationally and internationally, and his work has been featured in numerous scientific publications. Phone: 480-250-6757 Website: www.rubinmedical.com

born from such a variety of sources and its treatment has been equally as enigmatic. COBAT appears to represent a revolution in the management of fatigue potentially via a down-regulation of IL-6 levels and

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COBAT: Animal Case Studies

Clear Improvement in Quality of Life: Hints of Additional Benefits

by Janis Daniel Dees, Veterinary Nutritional Consultant

first became aware of COBAT when I attended a lecture given at the American Academy of Anti-Aging Medicine Conference by a former researcher at NIH, in December of 2001. Some of the immunological responses witnessed by researchers at the University of Maryland are remarkable. COBAT'S antitumor, and therefore, life-extending potential with respect to melanoma and myeloma progression in lab animals is fascinating (Knight, et al., see Animal Model pg. 3). It is exciting to see promising results regarding the regulation of immune system function and the effects it has on TNF - all without potential toxic side effects! I was eventually appointed Director of Companion Animal Studies for the use of COBAT for one and a half years, actively participating in the studies. This included becoming involved on a first-hand basis with observing and documenting the overall benefits and effects of the compound on animals with cancer. As a Veterinary Nutritional Consultant for nearly 20 years, I have been utilizing nutritional therapies for the support of animals in disease states, including various stages of cancer. Our companion animals are experiencing the very same disease states and treatments that humans do everywhere. We are thus well equipped to judge the quality of life changes in animals. The same chemotherapeutic drugs, radiation and surgery techniques are used by veterinary professionals. The extreme fatigue, anorexia and depres sion commonly experienced by animals with cancer can occur with or without the use of chemotherapy or

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radiation. In the currently accepted understanding, our animal companions don't have the thought process needed to believe that they will feel better soon. The mystical workings of the animal mind is not capable of experiencing a placebo effect - at least no more than a good tasting biscuit or favorite snack might provide.

"Overall I have found, based on blood analysis by veterinarians and client responses, a remarkable improvement in quality of life and life-extension."

Janis Daniel Dees, Veterinary Nutritional Consultant

In September of that year I worked with Snooks, changing her diet to a raw food diet with nutritional support as the sole method of strengthening her immune system. Snooks appeared to thrive. The tumor would occasionally appear to have a fever but would shrink afterwards. In the beginning, she had ups and downs, but was mostly comfortable. Over time her energy increased long walks with her Mom and a great appetite showed she was ready to stay here for at least a bit longer. Snooks developed an additional tumor mass on her left rear leg, otherwise she appeared relatively unaffected. At this stage COBAT was started. Her energy increased and she appeared to have very little down time. She continued to feel well and have a great life. Snooks was doing quite well for an 11 1/2 year-old Boxer. Later, COBAT was discontinued. Following discontinuation, there were noticeable side effects: the gingival tissue around her teeth started growing proliferatively, her stamina diminished, her walks became shorter, she became quieter, and she started having central nervous system symptoms. The doctors believed the cancer had metastasized to her brain. Also, the cancer had noticeable spread to her spleen and her liver. As time passed, she lost her battle with cancer. However, Snooks outlived her original prognosis over 2 1/2 years. I often wonder if the COBAT had been continued, what the outcome would have been. Case 2: In January of 2003, Jager M., a 10 1/2-year-old spayed female Newfoundland Hound was diagnosed with a malignant melanoma on her left

Case Histories The following case histories are examples of the veterinary use of COBAT with animals who have fatigue in my personal involvement: Case 1: Snooks M., a 9-year-old female Boxer was diagnosed with an aggressive mast cell tumor on her front left shoulder in August of 1999. The growth was surgically removed with a poor prognosis for any longterm survival. Chemotherapy was decided against.

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In Focus March 2004

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

buccal mucosa, near her molars. By the time surgical excision was performed, the mass was the size of a large lemon. Clean margins were not obtainable due to the location of the mass because part of her jaw would have had to been removed. She was put on two different antibiotics, aspirin and a narcotic pain reliever as well as prednisone (contraindication for COBAT). Her condition was weakening and her front left elbow was swollen as well. She was in pain when she walked. Her appetite was diminished and she had lost her lust for life. At times, her Dad would have to carry her home because she just couldn't walk the return trip from the park where she had loved to play in her younger years. We then put her on a fresh food diet and supplements to reduce inflammation, improve immunity and protect her GI tract. She also initiated use of COBAT 6x. Gradually, she recuperated from the effects of surgery. One month later she was able to resume walks with her Dad and her stamina increased. Her appetite continued to improve. According to her Dad, Jager starting acting much younger - outwalking her companion dog and enjoying her playtime at the park. Over the next several months she continued using COBAT in conjunction with her supplements. Her quality of life had improved to the degree where the years had fallen away from her. Sometime during the month of September she discontinued the COBAT and continued on a limited version of her supplement program. Jager continued to enjoy good quality of life until late November of 2003, when her kidneys stopped functioning and we lost her. She had long outlived the original prognosis - the oral lesion never returned and her lungs never appeared to be affected. I can only conclude that COBAT had some effects on preventing what we would typically expect to be the next metastasis site, as well as helping to keep her quality of life high. Case 3: Rahula, a 15-year-old neutered male Siamese, developed a loss of attitude, appetite and had marked abdominal enlargement in mid September of 2001. He was examined and a blood chemistry profile was run. The abnormal values showed elevated AST and Total Protein, and no measurable GGT, or Alkaline Phosphatase. Elevated Total and Direct Bilirubin were also noted. The initial diagnosis was intracellular hepatic disease. The medications prescribed, were Pepcid AC, Lactulose and Amoxicillin. His condition did not noticeably improve. He was lethargic and anorexic. A second opinion was obtained mid October and an orange sized growth was palpable on his liver. The diagnosis was changed to liver cancer. The drugs were discontinued and he was put on a fresh

food diet with concurrent nutritional supplementation to support immune system function and liver detoxification. He was expected to survive three to four months. Albumin, Total Protein, Globulin and Bilirubin normalized, as did AST, however, Alkaline Phosphatase and GGT did not. His attitude and appetite slowly improved, as did his interest in returning to his normal daily activities. His abdomen however, remained distended and the growth on his liver unchanged when examined in late March 2002. At this time, he was started on COBAT. His Alkaline Phosphatase and GGT normalized. The other values continue to show stability.

Snooks M.

Rahula continues to show improvement in the quality of his life; he is alert; his appetite is good, his weight stable and he is enjoying his normal daily activities. On July 5th, Rahula celebrated his 17th birthday and as of mid September, 2003, COBAT was discontinued and he was considered to be in remission. s

Janis Daniel Dees has been a consultant specializing in the field of Veterinary Nutrition for almost 20 years. Working to enhance quality of life by utilizing methods correcting metabolic imbalances and deficiencies. In addition to writing articles for national publications, chairing lectures and conducting workshops, she is currently writing a book on animal nutrition and healing. phone: 661-266-9320 email: [email protected] website: www.JanisCares.com

Focus on NutriCology ®

Editor-in-Chief: Stephen A. Levine, Ph.D.

Managing Editor: Elise Zurlo, CNC Medical Editor: Jeffry L. Anderson, M.D. Assistant Copy Editors: Dan Milosevich, CN, Diane Raile, CNC & Luba Voloshko, Ph.D. Graphic Design & Layout: Elise Zurlo & Blake Dayton 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 NutriCology®/NutriCology ®, Inc. products, which are dietary supplements, are offered for the diagnosis, cure, mitigation, treatment, or prevention of any disease. The statements made herein have not been evaluated by the U.S. Food and Drug Administration. The products are not intended to diagnose, treat, cure, or prevent any disease. Copyright © 2004. NutriCology® . Special permission is required to reproduce by any manner, in whole or in part, the materials herein contained.

For more information call 800-545-9960 or e-mail: [email protected]

13

With good health and proper nutrition, normal CoQ10 basal blood concentration is approximately 0.8 µg/ml. To compensate for oxidative stress, higher plasma CoQ 10 concentrations are suggested. Higher concentration requires greater absorption. NutriCology® presents CoQ 10 with Tocotrienols, a CoQ10 formula with superior intestinal absorptive capabilities. Recently, a decisive clinical study proved that CoQ10 plasma concentration was doubled when CoQ 10 powder was administered in a hard shell, and tripled when administered in a CoQ10 softgel. CoQ10 with Tocotrienols exhibits maximum intestinal absorption in 5 hours CoQ10 with Tocotrienols contains CoQsol ®, a premium CoQ 10 formula for cardiovascular support, increased energy levels, and oral health.* CoQ10 with Tocotrienols is available in bottles of 30, 60 and 200 softgels. # 53450 CoQ10 with Tocotrienols, 30 softgels # 53460 CoQ10 with Tocotrienols, 60 softgels # 53470 CoQ10 with Tocotrienols, 200 softgels

2.5

Plasma CoQ10 concentration before and after15 days CoQ10 (60 mg/day) supplementation

2.13

2 1.5 1 0.5 0

1.42 0.83 0.93 0.85 0.85

To learn more about CoQ10 with Tocotrienols contact NutriCology ® or visit our website at: www.nutricology.com

(800) 545-9960

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

14

In Focus March 2004

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NutriCology , 30806 Santana Street, Hayward, CA 94544

NattoZyme

Nattokinase

Now Available: 40 mg (800 FU) per softgel! Available in April: 50 mg (1000 FU) per softgel!

Superior Nattokinase Products Available from NutriCology:

#54751 #55101 #55280 #55290 NattoZyme w/Vitamin E, 40 mg, 90 softgels NattoZyme w/Vitamin E, 40 mg, 300 softgels NattoZyme, 50 mg, 90 softgels (avail. April, 2004) NattoZyme, 50 mg, 300 softgels (avail. April, 2004)

What Doctors Are Saying

"In all my years of research as a professor of cardiovascular and pulmonary medicine, natto and nattokinase represent the most exciting new development in supporting cardiovascular health." Martin Milner, N.D.

President and Medical Director of the Center for Natural Medicine in Portland, Oregon; Professor of Cardiovascular & Pulmonary Medicine, National College of Naturopathic Medicine; and Medical Director of the Heart & Lung Wellness Rotation & Residency Program in Portland, Oregon.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

NutriCology

®

30806 Santana Street Hayward, CA 94544

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In Focus March 2004

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