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Immunotherapy: Thymus and Spleen Peptides



Cancer immunotherapy is a rapidly emerging field that has ancient roots in traditional medicine. For centuries, traditional Chinese medicine and other traditional health care systems have used specific herbal and mushroom formulations, as well as food substances, like thymus, to enhance immunity. There are many effective immunotherapies worldwide, such as thymus and spleen peptides, GcMAF, medicinal mushroom extracts, mistletoe injections, hyper T/NK cells, hyperthermia, and intravenous high-dose vitamin C or α-lipoic acid. Studies indicate a potential to improve immune efficacy using combination approaches involving immunotherapeutic agents with differing modes of action. Every effective cancer terrain treatment starts with more than one form of immunotherapy. It is important that cancer immunotherapy be customized to each patient individually based on their health status. Breast cancer patients usually show a disturbed, suppressed immune system. Intrusive surgeries, cytotoxic chemotherapy, radiation, and numerous immunosuppressive drugs (drugs that suppress the immune system) lead additionally to temporary or long-term immunity deficiency. The number of defense cells in the blood can be increased and their functionality improved or restored through thymus and spleen compounds. Thymus Extracts and Peptides The thymus gland, consisting of two lobes, is located behind the breastbone in front of the heart. To a large extent, the health of the thymus determines the health of the immune system. The thymus is a central lymphoid organ where bone marrow derived immature lymphocytes (a type of white cell) undergo differentiation and become active T-cell lymphocytes. They are called T-cells because they primarily mature in the thymus gland, although some also mature in the tonsils. T-lymphocytes, or T-cells, play a central role in cell-mediated immunity. The thymus changes its size and function during our life cycle. It is largest and most active in newborns, infants and in the years prior to adolescence. By the early teens, the thymus begins to shrink and thymus tissue is replaced by fatty tissue. Nevertheless, a small amount of T-lymphocyte production continues throughout adult life. Lymphocytes make up roughly 20 to 40 percent of the total number of white blood cells. Lymphocyte counts drop when bone marrow is suppressed during cytotoxic chemotherapy or radiation therapy. T-cells also decrease when the overall lymphocyte count drops. The thymus produces enzymes and hormone-like peptides that play an important role in the development, maturation, differentiation, and activation of T-cells.1 Thymic peptides include thympoeitin, thymulin, thymosin, and thymic humoral factor, which all have both central and peripheral activities. Studies with thymic peptides have shown a variety of effects on the immune system. Basically, thymic peptides act as chemical messengers to activate, regulate, and stabilize the immune system. In clinical trials, thymus peptides strengthen the effects of immunomodulators in immunodeficiency, autoimmune diseases, and neoplastic malignancies. There are two groups of injectable thymus products available for use in treatment: Purified extracts from animal (mostly calf) thymus glands which contain peptides (pTE) Synthetically produced thymus gland peptides (sTP) Both injectable purified thymus extracts (pTE) and synthetic thymic peptides (sTP) have been demonstrated to enhance the immune system of cancer patients to assist in fighting tumor cell growth and resist infections due to immunosuppression induced by the disease and antineoplastic therapy. There are over 40 different factors in a purified thymus extract, that impart its therapeutic effectiveness, but not all have been adequately researched. For this reason, it is not advisable to only use individual thymus peptides, but rather the entire pTE, or, in some cases, a combination of the two. There are also oral extract forms of thymus (from bovine sources) in capsules and tablets sold as a dietary supplement. Generally, pTE has been demonstrated to have the following biological activities: modulate the production, maturation and activation of T-lymphocytes and improve B lymphocyte function2, 3, 4 increase the number and function of T helper/inducer lymphocytes (T4 cells)5, 6 increase the number and function of T suppressor cells (T8 cells)7, 8 improve immune response through the enhancement of bone marrow function, and protect against bone marrow suppression from cytotoxic chemotherapy and radiation 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 prevent secondary infections due to immunosuppression caused by cytotoxic chemotherapy and surgical interventions20, 21 increase response rate of anticancer therapies through improvement of lymphocyte function and biological defense mechanisms22, 23, 24, 25, 26, 27, 28, 29 History of Thymus Therapy Thymus therapy can be traced back to Dr. Elis Sandberg from Sweden, who was having promising results in treating chronic diseases and cancer as far back as 1938.30 Dr. Sandberg was able to manufacture a purified thymus extract (pTE) that included several peptides in a high-molecular concentration, and called this new substance “THX.” By the 1980’s, Sandberg had successfully treated more than 50,000 patients with THX. In addition to the positive results of his treatment, many of his patients experienced significant anti-aging effects. This method has been used in Germany now for over 40 years and in many clinics has replaced the classic method of Live Cell Therapy developed by Professor Niehans. An exponentially-growing number of international scientific publications on the thymus gland and the use of pTE for cancer have emerged. Several international pharmaceutical companies have invested intensively into thymus research and produced pTE and sTP for the therapy of diverse diseases, especially cancer. However, most large pharmaceutical companies have ceased their production of thymic peptides since the beginning of the 21st century. Instead these companies have focused on developing patentable, and extremely expensive remedies such as interferons, interleukins, or monoclonal antibodies. This is partly because thymic peptides cannot be protected by patents. Hence, there is no profit in producing them. Additionally, alongside this decline in thymic peptide production, extensive propaganda suggests that there is a lack of quality evidence for pTE as an adjuvant to orthodox cancer treatment. This, however, is simply not true. Commercial Purified Thymus Extracts (pTE) and Thymic Peptide Preparations Since Elias Sandberg’s development of THX in the 70s, several injectable forms of pTE have been used in Europe for restoration of the immune system and in treatment of breast cancer. 31, 32 To date, more than twenty thymus peptides have been isolated from the whole-thymus extract. In Europe, pTE treatment is usually given on an outpatient basis. The classic pTE treatment course depends on the preparation used, and treatment is always individually adjusted in dosage, frequency, and duration depending on the condition of the patient. Even though there are more than 500 scientific publications which discuss the effects and efficacy of injectable thymus extracts and their peptides, there are only a few pTE injectable products available in the European market. This fact is unfortunate, as limited availability means limited usage. Overall, this will impede further scientific research. The injectable pTE extracts that are available come with their own manufacturer’s recommended protocol of treatment. I will discuss three pTE preparations and another unique peptide used for immunotherapy in breast cancer patients. These products are currently all available in Europe. Thymex-L An ampule of Thymex-L consists of 150 mg lyophilised, sterile, total thymus extract isolated from fresh juvenile calf thymus and standardized to 0.6 mg / mg thymus cytoplasmatic protein. Thymex-L extract has a wide range of application for illness due to reduced immunity, especially a deficiency related to cytotoxic chemotherapy or radiation therapy. It has yielded good results in adjuvant cancer treatment of breast, lungs, uterus, prostate, Hodgkin's disease and Kapose's sarcoma. In 1992, researchers at the Institute of Oncology and Radiology in Belgrade, Serbia, conducted a study of lung cancer patients who took Thymex-L simultaneously with radiation therapy. The researchers concluded that, “Thymex-L can successfully prevent the harmful effect of radiation therapy on cellular immunity in a majority of lung cancer patients.”33 In 1995, researchers were able to enhance monocyte activity in melanoma patients injected with Thymex-L. The researchers concluded that, “depressed monocyte functions in selected melanoma patients may be partially improved by Thymex-L.”34 The manufacturer’s recommended dosage of Thymex-L for immune support following cytotoxic chemotherapy or radiation therapy suggests that injections should be administered every other day for a total of 10-20 injections. This treatment schedule depends, of course, on the patient’s health and the stage of the cancer. THYMEX-L® treatment can be repeated after an interval of 3 to 12 months. If necessary, long-term treatment with THYMEX-L®can be administered. Then, one injection twice a week is recommended as maintenance. TFX-Thymomodulin TFX-Thymomodulin, like Thymex-L, is a purified thymus extract derived from the thymus glands of calves. It is an approved drug in Italy, and is used throughout Europe as an immune treatment. Research and human trials have shown good results with a number of conditions involving immune deficiency or dysfunction and infections.35, 36, 37, 38, 39, 40 According to the manufacturer, 1 package of TFX-Thymomodulin includes 10 injection vials containing 10 milligrams of lyophilisate and 10 ampules of solvent. This product is composed of 6 thymic peptides. TFX-Thymomodulin can be administered with subcutaneous or intramuscular injection. However, it must first be dissolved in 2 ml of normal saline and then used immediately. The manufacturer recommends that the dosage of TFX-Thymomodulin be determined on an individual basis depending on the health of the patient. For immune support following cytotoxic chemotherapy or radiation therapy, the typical dosage is 10 to 20 mg a day for 30 days followed by 20 to 50 mg once a week. Thymus Peptide C Thymus Peptide C is another purified thymus extract from the thymus gland of young calves. Its properties are like Thymex-L and TFX-Thymomodulin. Hence, Thymus Peptide C is used as an immunotherapy in breast cancer and immunodeficiency caused by cytotoxic chemotherapy and radiation therapy. One package of Thymus Peptide C contains 10 vials of 25 mg. As with the other preparations, the dosage needs to be determined on an individual basis depending on the health of the patient. The following is a typical dosage for immune support following cytotoxic chemotherapy or radiation therapy: 25 mg/day for 30 days followed by 25-30 mg/week. As with all pTE, the continued administration, dosage, and duration of the treatment depend on the therapeutic effect and health status of the patient. Thymus Peptide M (LUPEX) Some European doctors use a thymus extract together with Peptide M as LUPEX to treat breast cancer with immunodeficiency. One vial of LUPEX contains 5 mg or 10 mg of Peptide M, a low molecular short chain synthetic peptide. It is a ubiquitous peptide present in the body. In a low quantity it is also found in the thymus gland. Its range of application includes bone metastasis by mamma-carcinomas, as well as other carcinomas. LUPEX is available in 5 or 10 mg options. Both must be dissolved in 2 ml of physiological saline before they can be subcutaneously injected with a very thin needle. Injections should be given while the patient is lying down and they should rest for at least 15 minutes after the injection. A recommended LUPEX dosage schedule for immune support following cytotoxic chemotherapy or radiation therapy is 5 mg subcutaneously, five times a week, or two to three times a day up to a maximum total daily amount of 40 mg depending on the severity of the disease and each individual. LUPEX can also be used as a long-term treatment, starting with two injections weekly. Then, one injection weekly for one or two years. Side Effects of Thymus Extract and Peptides There are no known side effects with the above purified thymus extracts or LUPEX. However, at the injection site, erythema, or a slight sensitivity, could develop. In such cases a one- or two-day break from the treatment is indicated. Thymus Extract and Peptides Availability For now, these thymus preparations are only available in Germany and a few other European countries. They may be imported to the U.S only in small amounts for personal usage and not for resale. Even though there has been a decline in pTE production in Europe and there have been restrictions on their import into the U.S., thymus peptides are poised to make a huge impact on cancer treatment in the near future. This is because they stimulate cellular immunity without side effects and are relatively inexpensive. Big Pharma is manufacturing immunotherapy medications such as Keytruda and Opdivo that target the surface receptors that inhibit T-cells. These medications carry numerous side effects, some quite serious, and are very expensive. Thymus extracts and peptides have a proven safety record and are a fraction of the cost of these designer immunotherapy medications. Spleen Peptides Another organ peptide preparation used in cancer therapy in Europe is splenic peptides. The spleen is the largest organ of the lymphatic system and contributes to a fully operational immune system. The spleen combines the innate and adaptive immune system in a uniquely organized way. The structure of the spleen enables it to remove older red blood cells from circulation and leads to the efficient removal of blood-borne microorganisms and cellular debris. It is made up of B- and T-cell lymphocytes, macrophages, dendritic cells, natural killer cells, and red blood cells. This organ can be thought of as an immunological conference center. In the spleen, B-cell lymphocytes become activated and produce large amounts of antibodies. Microbial penetration of tissues, or a tumorous terrain, evokes an immediate immune reaction of the spleen. The spleen, like the thymus, also produces peptides that have a number of important effects on the body. These peptides are notable for improving both immunity and detoxification of the body. Specifically, certain splenic peptides have been shown to bind to specific receptors on the surface of white cells such as macrophages and polymorphonuclear leukocytes. This, in turn, stimulates their migration, phagocytic, bactericidal, and tumoricidal (antitumor) activity.41 Like pTE, splenic peptides are capable of restoring immune functions damaged by radiation and chemotherapy. They stabilize the lymphocytic status and improve the patient’s general health. For more than 50 years, splenic peptides have been used in supportive tumor therapy aimed at improving the patient’s poor general state of health. Splenic peptides are obtained from porcine spleen. The main constituents of the active ingredients in splenic peptides are oligopeptides and polypeptides. Depending on the method of manufacture, however, splenic peptide preparations may vary widely in their individual composition. Commercial Spleen Peptides Preparations Several splenic peptide preparations are available in Europe for enhancing immune function, particularly after surgery, radiation therapy, and cytotoxic chemotherapy. Two of the most researched are Polyerga and SPLENIN.42, 43, 44 Polyerga is available in both oral form as well as injectable. The oral form is called Polyerga Plus and includes polypeptide tablets and oligopeptide capsules. According to the manufacturer, a tablet is taken before meals three times daily and a capsule is taken every other day before a meal. Each vial of SPLENIN contains: 50 mg of polypeptides from porcine spleen as a freeze-dried powder as the active ingredient. According to the manufacturer, dosage is as follows: for one week from Monday - Friday administer 1 vial of SPLENIN daily. Then for two weeks, three times a week, administer 1 vial of SPLENIN. After that, administer 1 vial of SPLENIN twice a week for three weeks. Further administration of SPLENIN is determined on an individual case basis by the physician and depends on the patient's condition and tolerance of therapy. Repeated treatment is recommended after 6 weeks or 3 months. In severe cases, long-term therapy where 1 vial of SPLENIN is administered 1-2 times a week may be considered. The combination of thymic peptides and splenic peptides is useful in general immune deficiencies and reduced resistance during cancer treatment. While thymic peptides regulate T lymphocytes and recruit new T-cells from the bone marrow, splenic peptides have a greater influence on the B lymphocytic defenses. Hence, patients whose immune systems are suppressed due to radiation and cytotoxic chemotherapy are good candidates for thymus and spleen peptide therapy. These treatments can be used together or separately and, like all treatment plans, should be individualized to the patient’s condition. Most conventional U.S. physicians and oncologists know little - if anything - about this type of peptide therapy. With no knowledge, most physicians will not recommend trying it, even though side effects are almost non-existent.

For more articles on thymus therapy, consult our BRMI library by clicking here. For even more information, including physicians who offer thymus extract and spleen peptide therapy, as well as how to purchase thymus, visit www.thymus-therapie.org.

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Department of Pharmacology, School of Medicine, University of Milan, Italy. Thymomodulin stimulates phagocytosis in vitro by rat macrophages and human polymorphonuclear cells. Chemother. October 1993; volume 5, number 5, pages 313-316. 40. Lantero S, Oddera S, Silvestri M, Ottolini V, Sacco O, and Rossi GA. Division of Pneumology, G. Gaslini Institute, Genoa, Italy. Thymomodulin enhances phagocytic and intracellular killing activities of polymorphonuclear leucocytes without increasing release of chemotactic factors. Monaldi Arch. Chest Dis. 1993; volume 48, number 1, pages 29-33. 41. Najjar V, Nishioka K (1970). ""Tuftsin": a natural phagocytosis stimulating peptide" (abstract page). Nature 228 (5272): 672–3. 42. Porcine splenic peptides (Polyerga) decrease the number of experimental lung metastases in mice. Jurin M, Zarković N, Ilić Z, Borović S, Hartleb M.Clin Exp Metastasis. 1996 Jan; 14(1):55-60. 43. Zarkovic N, Hartleb M, Zarkovic K, Borovic S, Golubic J, Kalisnik T, Frech S, Klingmüller M, Loncaric I, Bosnjak B, Jurin M, Kuhlmey J. Spleen peptides (Polyerga) inhibit development of artificial lung metastases of murine mammary carcinoma and increase efficiency of chemotherapy in mice. Cancer Biotherapy and Radiopharmaceuticals 03/1998; 13(1):25-32. 44. Gulubova MV, Ganeva MG, Zaneva MA. Rat liver piT-cells following administration of the glycopeptide preparation (Polyerga). Hepatogastroenterology. 1995 Sep-Oct;42(5):698-704.


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