Immune Fx

INTRODUCTION

The following article details why Immune Fx is beneficial to COMPLEMENT standard therapies such as chemotherapy and radiation.

Mushrooms have long been prized around the world for their extraordinary Medicinal and Immune-Enhancing qualities. Today, we’re proud to offer as complementary nutritional immune support a potent and very safe, pharmaceutical quality blend of 6 effective mushroom extracts and six whole mushroom mycelium powders, to be used in conjunction with chemotherapy, radiation, or surgery. This formula can also be used by people who have completed conventional treatment, or by people who just want to significantly strengthen their immune systems to aid in warding off illness and disease.

Unlike most other complementary or alternative cancer therapies offered in North America, the substances in Medicinal Mushrooms are being used as mainstream therapy in other countries, and have actually been proven (in laboratory, animal, and human studies - refer to REFERENCES & RESEARCH ARTICLES) to have powerful anti-carcinogenic activity. They have also been shown to significantly enhance the body’s own immune system to eliminate, or stop the spread, of many tumors.

Recent research on the combination found in Immune Fx demonstrated that use of the combination significantly reduced the adverse effects of radiation and chemotherapy, including loss of appetite, energy, and loss of hair, as well as reducing the incidence of nausea. These “quality of life” measures are very important because loss of appetite and malnutrition are a major cause of treatment failures with conventional therapy. This same research also demonstrated the combination’s ability to “improve immunity with high effectiveness and non-toxicity.”

MEDICINAL MUSHROOMS AND CANCER

Medicinal mushrooms have a long history of use in folk medicine for cancer and many other diseases. Starting in the mid-20th century, modern scientists have conducted hundreds of laboratory, animal, and human experiments that have verified the power of more than 180 of these fungi as anti-tumor agents. The six mushrooms in Immune Fx have been shown to have particularly powerful anti-tumor and immune-enhancing effects.

An example of one of these studies on animals was conducted in Japan in which mice were injected with cancer cells. The mice were then divided into 3 groups - a control group, a group that was fed a diet consisting of 20% maitake powder, and a group that received an injection of 1mg of Maitake D-fraction per 2.2 pounds of body weight. It was observed that metastasis was prevented by 81.3% in the group that was fed the Maitake powder and by 91.3% in the group injected with d-fraction. There was no inhibition of the cancer at all in the control group.

The fact that these mushrooms are so effective shouldn’t be surprising since the largest group of our conventional medicinal substances comes from the fungus kingdom. Most of our antibiotics, anti-rejection drugs for organ transplants, high-cholesterol medications, and many other pharmaceuticals still come from the compounds found in fungi. Once these drugs were discovered in the fungi, ways were found to efficiently and cheaply synthesize them in the laboratory for large-scale pharmaceutical production. So far, this has not been possible with the most important class of medicines found in the medicinal mushrooms - the Beta-Glucans. These substances are so complex that scientists have still not learned how to reproduce them in a test tube.

One of the key functions of Beta-Glucans and the other polysaccharides found in medicinal mushrooms is to stimulate the production of immune cells to guard our other cells against foreign invaders, and to protect us from our own aberrant cells (cancer). Countless studies over the last 40 years have confirmed the ability of these polysaccharides to stimulate the following immune system components: interferon, interleukin, tumor necrosis factor (TNF), natural killer cells (NK), B and T lymphocytes, tumor-infiltrating lymphocytes (TIL’s), lymphokine activated killer cells (LAK), macrophages, granulopoiesis (the production of granulocytes in bone marrow), and thrombopoiesis (the production of platelets in bone marrow).

Another function of Beta-Glucans is to attach to the receptor sites on the immune cells and to activate them, allowing them to recognize the cancer cells as “foreign invaders” and creating a higher state of immune response. This is the primary pathway by which medicinal mushrooms help the body to fight off invasion by diseases and cancer cells. Scientists refer to this process as “immunomodulation,” or modulation of the body’s immune system.

In addition to the Beta-Glucans and other polysaccharides, these extraordinarily complex fungi contain other substances which have also shown significant anti-cancer capability in laboratory experiments. These include terpenoids, lectins, steroids, and dietary fiber. The latter, for example, fortified with medicinal complexes, has the ability to absorb carcinogenic substances, thereby preventing their absorption into the intestines and hastening their excretion from the body.

While each of the mushroom extracts in Immune Fx has proven anti-tumor and immune-modulating power, no single mushroom has yet been proven to be effective against all cancer cell lines, or in stimulating all of the body’s different immune system components and processes. Scientists have discovered that the substances found in different medicinal mushrooms have varying effects on tumors and the immune system. For example, the authors of one study on Agaricus blazei Murill in 1998 noted that while a fraction of the mushroom was “not effective against tumor cells derived from human hematopoietic malignancies, these products are remarkably effective against solid tumor cells from glioblastoma patients.”

By combining these six potent mushrooms, which have all shown anti-cancer capability in vitro, in vivo, and in human clinical studies into one formula, Immune Fx is designed to be the most comprehensive formula of its type available today.

Human Use of Medicinal Mushrooms in
Complementary Cancer Therapy

Complementary immune-enhancing Medicinal Mushroom therapy is commonly used in conjunction with mainstream medicine in several (most) countries, and as nutritional therapy by many practitioners and doctors in the United States.

In Japan and some other countries, several specially extracted or manufactured extracts of individual mushrooms, (with an emphasis on isolating specific polysaccharides) have been licensed as medicines, and some of these are available in the United States. These include Maitake D-Fraction®, Bao Li Sheng, PSK (reported to be the largest selling cancer medicine in the world, which is also known under the trade names Coriolin® and Krestin®), PSP, MGN-3 (from Shitake mushroom), KS-2 and AHCC.

The first modern published trials of Medicinal Mushroom extracts began in Japan in the early 1970’s. One example is a polysaccharide extract from the Coriolus versicolor mushroom- PSK. As a complement to chemotherapy or radiation, PSK significantly extended survival at five years and beyond in cancers of the stomach, colon-rectum, esophagus, nasopharynx, and non-small cell lung cancer, as well as certain types of breast cancer.

PSK was also tried on people whose conventional therapy had limited success. One example was a trial started in 1977 on 185 patients with non-small cell lung cancer whose radiotherapy had only been “marginally effective.” Sixty-two of these patients were randomly selected to receive PSK. After five years, almost 4 times as many patients treated with PSK were alive, compared to the group that did not consume the mushroom extract.

Another closely related extract of the same mushroom – PSP, was subjected to double-blind studies in China which showed that PSP significantly extended five-year survival in esophageal cancer. It also improved quality of life, provided substantial pain relief, and enhanced immune status in 70% to 97% of patients with cancers of the stomach, esophagus, lung, ovary, and cervix. Both PSK and PSP boosted immune cell production, ameliorated chemotherapy symptoms, and enhanced the chemo-sensitivity of the cancer cells.

Recent research has indicated that whole mushroom extracts, with concentrations of polysaccharides, are more effective than isolated polysaccharides. Several studies have shown that other components of the mushrooms, besides the polysaccharides, also have anti-cancer and healing properties. The combination of all these elements, as found in whole mushroom extracts, appears to be superior.

Due to the nature of our country’s drug approval process, it is likely to be many years before chemicals from these safe substances are approved as drugs in this country, and are incorporated into our medical system. Until then, Medicinal Mushroom extracts are available as healthy foods that can be used as nutritional support in conjunction with conventional cancer therapy, without interfering with other therapies.

THE IMMUNE FX FORMULA

The ingredients are all organically grown and the extraction process is done by a leading pharmaceutical manufacturer experienced in the extraction of Beta-Glucans. The raw ingredients have not been irradiated or altered with GMOs, and it contains no fillers. 100% active ingredients. The formula is packaged in bottles of 90 - 500mg capsules for a 30 – 45 day course of therapy.

Each capsule of Immune Fx contains:

The Mushrooms in Immune Fx

AGARICUS BLAZEI MURILL (“ABM”)

ABM is one of the most amazing medicinal mushrooms yet discovered. Due to its anti-tumor effects, this mushroom, which grows wild in Brazil, is now extensively cultivated in Japan and China and is now becoming more popular with American mushroom cultivators.

The main medicinal properties of this mushroom are anti-tumor and immune enhancement. In almost all the laboratory studies published to date, the rate of remission for all types of cancer has been in the high 90% range. While most of these studies have been done with mice, rats, or guinea pigs, similar results may be shown as clinical studies are conducted on humans. One human study showed that human subjects given ABM in their diet experienced an increase of NK (Natural Killer) cells of 3,000% in 2-4 days. The largest and most complete human trials are presently being done in China and Japan. It is likely to be many years before these studies are completed and widely circulated in America.

Laboratory experiments have confirmed that several substances in ABM, in addition to the Beta-Glucans and other polysaccharides, have anti-tumor effects. These include nucleic acids, lectins, sterols, and lipids.

CORDYCEPS SINENSIS

For thousands of years, Cordyceps has been highly valued in China as a tonic food and herbal medicine. Until recently, it was only available in nature as it grows in the body of a caterpillar. Thus, the fungus was rare, very expensive, and subject to contamination. Today, a potent strain of Cordyceps, CS-4, is grown in a liquid broth medium under sterile conditions, making it safe, affordable, and available for use as nutritional therapy for many conditions.

As with the other medicinal mushrooms, the anti-cancer effects of Cordyceps appear to come from its polysaccharides, as well as its sterols, lipids, nucleosides and especially in the de-oxy nucleosides, which have been found in no other source in nature. Many studies have shown this mushroom’s ability to stimulate and modulate the immune system and increase red blood cells. As an immune modulator and adaptogen, Cordyceps was shown to boost depressed immune function, but not enhance a normally functioning immune system to the same degree. In published research from China, Cordyceps was reported to have anti-tumor activity against lung cancer in both mice and humans.

In a number of human clinical trials and in Traditional Chinese Medicine, Cordyceps has been shown to improve liver, kidney, cardiovascular, and respiratory functioning. Since these organs and systems can be adversely affected by cancer and its treatments, Cordyceps can contribute to overall health, besides having anti-tumor effects.

CORIOLUS VERSICOLOR

Commonly known as Turkey Tails, this is a hard woody fungus that can be found growing in woodlands all over the world.

Like other mushroom-derived Beta-Glucans, the polysaccharides from Coriolus act in the human body as immuno-modulators and activate the immune system to fight cancers. In repeated animal studies, Coriolus has shown activity against Sarcoma 180 in the high 90% range.

Hundreds of studies have been published on two extracts of Coriolus, which are also two of the most commonly prescribed anti-cancer medicines in the world - PSP and PSK. They are both protein-bound polysaccharides of the Beta-Glucan variety and the published research show that these extracts improve T-cell ratios, NK cell activity, and IL-2 levels. In animal studies, PSK, for example, has shown anti-tumor activity in animals with adenosarcoma, fibrosarcoma, mastocytoma, plasmacytoma, melanoma, sarcoma, carcinoma, and mammary, colon, and lung cancer.

In one controlled clinical trial of PSP, patients with esophageal cancer were given 3g/day orally in combination with chemotherapy. The patients receiving the PSP and chemotherapy had a remission rate of 72%, whereas those on chemotherapy alone had a remission rate of 42%.

MAITAKE (GRIFOLA FRONDOSA)

Maitake mushrooms have a long history as powerful medicinals dating back to the Han dynasty (206 BC to 220 AD) when they were used to treat stomach and spleen ailments, hemorrhoids, and nervous disorders. Studies started in the mid - 1980’s have shown that Maitake extracts protect against hepatitis, inhibit tumors, help regulate blood pressure, blood sugar, and cholesterol, and control obesity.

Maitake’s anti-tumor activity is quite potent, but like all of the medicinal mushrooms it is more effective with some tumors than with others. One study published in 1989 showed that one specific isolated Maitake extract was effective with allogenic and synergenic tumors, but did not inhibit the growth of leukemia. In another study, the results suggested that breast, lung, and liver cancers were improved by maitake, but it was less effective against bone and stomach cancers, or leukemia.” Recently, reports have come from China indicating that a large daily dose of Maitake D-Fraction (3 grams/day), (as per Dr. Nanba's original formula designation; not necessarily the same thing as "D-Fraction" [TM] available over the counter in the USA) combined with conventional treatments, has significantly increased the remission rates for lung cancer (82% remission with Maitake vs. 9.8% without).

Recognizing the benefits of Maitake, a trademarked brand of Maitake D-Fraction, called “Grifon® -Pro D-Fraction® received FDA approval in 1998 to conduct a Phase II study on its effect on advanced breast and prostate cancer patients. (Note: the Maitake in Immune Fx is the D-Fraction extract as per Dr. Nanba's original research designation. It is not the "D-Fraction" [TM] that is Trademarked in the United States).

It is significant that the FDA, recognizing the safety of this mushroom, allowed the sponsors to bypass the normally required Phase I studies which test for toxicity. If the Phase II study is successful, it should be followed by a series of Phase III studies and Maitake may be approved as a drug in this country in 10-15 years (probably at a much higher price). Until then, it will only be available as a nutritional supplement and not qualify for insurance reimbursement.

REISHI (GANODERMA LUCIDUM)

This great tonic herb and adaptogen is renowned in China as a “longevity” herb. It was described in a Chinese medicine text as “supporting the vital essence and securing the root” and “if consumed for a long time will provide a light and dexterous feeling, reducing aging and improve longevity.”

As a tonic and adaptogen Reishi has been shown to enhance and modulate the immune system and to increase a patient’s tolerance for chemotherapy and radiation, while reducing side effects like leucopoenia and decreased food appetite.

The polysaccharides, sterols, and triterpenes in Reishi have been shown to possess significant anti-tumor capability in laboratory studies and in anecdotal reports and non-randomized clinical reports on Reishi’s effect on humans from Japan, China and Russia. Reishi has been shown to specifically enhance Natural Killer and Cyto-toxic Lymphocyte activity when consumed orally. In one placebo-controlled study, Reishi showed a marked immune-modulating effect with an increase in T lymphocytes. This included T helpers in patients whose immune system markers were below normal, while little effect was seen in patients with normal immune indexes.

SHIITAKE (LENTINULA EDODES)

Shiitakes are the oldest cultivated mushrooms and have been known by Asian healers for their healthy properties for thousands of years. The extraordinary mushroom first came to the attention of western science in 1969 when the Japanese government found that two areas of Japan with a very low incidence of cancer were also Shiitake growing regions. Research on this extraordinary mushroom was started, and by 1975 the first mushroom derived anti-cancer drug was approved by the Japanese government. This drug, an extract from Shiitake, is called Lentinan (1-3{3}1-6 D-Beta-Glucan) and is now widely prescribed for primary cancer therapy. Since then, other drugs (and nutritional supplements) have been made from Shiitake, including MGN-3, KS-2, LEM, and GVHR. As with the other medicinal mushrooms, the most active ingredients in Shiitake are the polysaccharides.

In the early (1969) experiments on Shiitake extracts, mice implanted with Sarcoma 180 (a standard cancer cell line used in research) were given injections of 6 mushrooms collected in the wild in Japan. With one exception, 5 of the mushrooms, including Shiitake, produced high rates of tumor inhibition (72% to 92%). It was also observed that Shiitake cured the cancer in 60% of the mice, more than any of the other mushroom extracts. This led to the isolation of several active polysaccharides and the creation of the drug, Lentinan.

While most of the research until now has been done on Lentinan and other specialized Shiitake extracts, the whole mushroom has also shown impressive anti-tumor effects, with inhibition rates on implanted tumors as high as 72%.

In human studies in Japan, Shiitake extracts have principally been used to support immune function in cancer patients during chemotherapy, often leading to increased survival times, in addition to reducing the toxic side effects of the chemotherapy and radiation-therapy.

The Clinical Trials on the Combination Found in Immune Fx

Between August 2000 and April 2001, a clinical trial of the specific 6 mushroom combination was conducted in China under the auspices of Zhejiang Medical University (one of the world’s largest) on 56 middle-late stage cancer patients with a variety of cancers, including gastric, liver, lung, large intestine, and naso-pharyngeal.

The purpose of the study was to test the effect of the specific 6 mushroom combination as adjunct therapy (with chemotherapy and radiation) on the immune system. This clinical trial differed from similar trials held in America under similar conditions. In our country the experimental medicine (in this case, Immune Fx) is usually compared to a placebo. In other words, half of the trial group gets a “sugar” pill and the other half gets the new medication.

In China, this practice is considered unethical and inhumane, especially when the experimental medication has a long history of safety. Instead, when a new medication shows enough promise to warrant clinical trials, the new one is tested against the very best medication available. In this trial, the specific 6 mushroom combination was compared to Polyactin-A, a drug used in China to enhance the immune system and to reduce the incidence of side effects of cancer treatment. For the specific 6 mushroom combination to be successful in this trial, it had to produce results that were superior to Polyactin-A.

The results of this preliminary clinical study showed that the specific 6 mushroom combination was superior to Polyactin-A in every parameter measured for Quality-of-Life measurements (appetite, KPS scores, nausea, sleep, and overall symptoms). Other results of the trial include the following:

The specific 6 mushroom combination inhibited the protein synthesis of cancer cells, changed the physiological condition of cancer cells, and inhibited the growth and transference of cancer cells.

The specific 6 mushroom combination enhanced the patients’ nonspecific immunity, improved the secretion of IGA, increased the function of monocyte-macrophage, increased the activity of NK cells, and helped maintain the immunological balance and stability of the body.

The results indicate that the mixed polysaccharides of medicinal mushrooms in the specific 6 mushroom combination had “an apparent role in the treatment of all kinds of cancer, protecting the haematopoiesis function of the bone marrow, inducing the action of the digestive tract, increasing the immunity of the cells, increasing the activity of the NK cells, the LAK cell and the ratio of the Th/Ts cells. The curative effect of this polysaccharide mixture is higher than that of Polyactin-A A, and has an excellent helper role as an adjunct for the treatment of tumor patients.”

Authored by the late Tom Hickey, a brilliant herbalist from Los Angeles

FREQUENTLY ASKED QUESTIONS

Do I need to see an oncologist if I take Immune Fx?
Yes! Absolutely! Immune Fx is meant as a nutritional adjunct (or, complementary therapy) for people receiving conventional treatment or for people who have no further conventional treatment options. It is not meant to be an alternative to conventional cancer treatments.

Conventional oncology has a great deal to offer and improvements in conventional treatments are happening at a fast pace. The fact is that when it comes to curing cancer, conventional mainstream oncology has a better track record than anything else. Every cancer patient should work closely with an oncologist from the first diagnosis throughout treatment.

However, since conventional oncology cannot guarantee a 90% or 100% cure rate for most cancers, many patients find it wise to explore nutritional and other therapies, including lifestyle changes, to attempt to improve the outcome of their conventional treatments. This should be done openly with your oncologist’s knowledge and most oncologists will welcome your openness and efforts.

Do I need any other supplemental therapy besides Immune Fx?
Yes! We strongly recommend a “shotgun,” rather than a “rifle” approach in confronting cancer. Many activities, supplements, mind exercises, and lifestyle changes have been shown in thousands of studies to have some positive effect in preventing metastases, enhancing remission, preventing recurrence, and enhancing the quality of life. So long as the things you take, or do, do not contradict each other, it is probably wise to use everything you can, that has been shown to be safe and effective (to a greater or lesser degree), to deal with this vicious disease.

Most adjunctive therapies will not have a negative effect on your conventional treatments and some nutritional therapies, like Medicinal Mushrooms, can actually enhance your treatments. However, this is not true for all nutritional supplements. For example, some antioxidants have been shown to interfere with some chemotherapy agents and with radiation. Selenium, for example, has been shown to enhance chemotherapy, but to possibly interfere with radiation. Other antioxidants, like Vitamin C, have been shown to be of benefit with all conventional treatments.

Is it true that some polysaccharides and Beta-Glucans cannot be absorbed when taken orally?
Yes. Beta-Glucans are extremely large organic molecules and some are not readily absorbed in the stomach and intestines, but pass through unchanged. But as the Beta-Glucans are long chain molecules, research has found that breaking the chain into shorter segments makes the substance more readily bio-available while maintaining the same clinical properties. One-way to do this is to co-administer vitamin C with the mushroom extracts. It is not possible to mix the vitamin C with the formula ahead of time, as the breakdown process continues and ultimately leaves behind just simple sugar molecules. But the addition of 1,000 mg (1 gram) of vitamin C at the same time the mushroom or mushroom extracts are taken, logarithmically increases the absorption of the Beta-Glucans, making them much more bio-available to the system. (The enzymes found in Ginger root and Pineapple may also accomplish the same effect, for those that cannot take vitamin C supplements)

Can I take Immune Fx to strengthen my immune system to try to prevent cancer?
Immune Fx is a very potent formula and one would not need to take it on a long term basis unless they have cancer. Almost everyone can maintain a healthy, functioning immune system with a healthy diet, a much less intense mushroom supplement, and antioxidants. While younger people with healthy lifestyles may maintain a strong immune system without nutritional supplementation, this is difficult for people over 40, since the concentration of antioxidants and other important substances in our bodies decline as we get older. People with compromised immune systems, or people wanting to give their immune systems an initial boost might consider taking Immune Fx for one or two months, or taking a reduced dosage over a longer period of time to give their immune systems a boost. The benefits should be cumulative.

Are there any negative side effects with Immune Fx?
Some people will experience an initial stomach upset and/or loose stool. These usually pass within 3-5 days. To minimize the chance of gastric upset, you may want to eat some food just before taking Immune Fx and/or dividing the daily dose into four, instead of two doses.

Why does Immune Fx have so many mushrooms in it?
There are two reasons for this:

First, each of the mushrooms is very different from the others, with its own distinct bio-chemistry and no single mushroom works well on all aspects of the immune system or on all cancers. While one mushroom might inhibit the growth of a specific cancer cell type in 85% of the experimental subjects, another mushroom might only inhibit the growth of the same cell line in fewer than 10% of the subjects. By consuming a concentrated dose of several potent mushrooms, we believe the chances of successful nutritional therapy are enhanced.

Second, just as herbs with similar functions in an herbal formula have an additive effect when taken together, the same is true for this formula. By focusing two or more effective substances on a cancer cell, it is believed that the outcome can be significantly improved.

What can Immune Fx do for me if there are no further conventional treatments available?
As nutritional support that enhances your immune system and other bodily functions, the formula should improve your general health and quality of life. It may also have a beneficial effect on your cancer, but we cannot, and do not, make any claims that it will. Published studies on medicinal mushrooms certainly provide a basis for trying these substances, but this is a personal decision that you will need to make yourself after doing as much research as you feel is necessary. If you decide to try Immune Fx, you should begin to experience some tangible benefits within the first 1-4 weeks.

If these mushrooms are so great, why aren’t they available as medicines that my insurance company will pay for?
We have a very complex system that does not encourage the designation of natural substances, like mushrooms, as medicines. In other countries, like China, Japan, and even Europe, natural substances are much more easily approved as medicines.

In our country, it costs about $200 million and takes at least 12-20 years for a drug to be approved. Because of this, individuals and companies are understandably reluctant to spend the money on a natural substance (like a mushroom) that can’t be patented. The current effort by Maitake Products, Inc. to get its D-Fraction approved is a welcome exception, but it will still take at least another decade (if successful) before doctors can prescribe it and insurers will pay for it.

By having such a difficult medicine approval process in America, we undoubtedly lack the benefit of many safe and natural substances in our medical system. Not only do we require an expensive and lengthy approval process, but the process does not distinguish between natural substances with a long-term safety history and a new isolated chemical with no safety history. In other countries, the approval process is much shorter and vastly less expensive for natural substances that are known to be safe. The pioneering effort of Maitake Products is to be commended, especially since it still faces a long and expensive journey to approval. The FDA should also be commended for recognizing the safety of Maitake and allowing the company to bypass the Phase I trials.

In the present circumstances, all you can do is research your natural therapy options as much as possible and make your choices. Unfortunately, you will have to pay for it yourself because most insurers won’t.

How soon after I am diagnosed should I start on Immune Fx?
You can start on Immune Fx as soon as possible before the start of chemotherapy, radiation or surgery. Your immune system needs to be as strong as possible before starting conventional therapy.

What can I tell my doctor about Immune Fx?
It is very important that your oncologist know about everything you are taking, including Immune Fx. You should feel free to give your oncologist this paper. Also, we would be pleased to send your doctor a package of major research articles about the mushrooms in this formula and the results of complementary mushroom therapy with cancer.

These claims have not been evaluated by the FDA. Our products are not intended to diagnose, treat, cure or prevent any disease.

REFERENCES and RESEARCH ARTICLES