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Medical Journalist Report of

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Medical Journalist Report of

    Townsend Letter for

    Doctors & Patients

    November 1999

    Reprinted with permission Townsend Letter for Doctors & Patients

    911 Tyler Street Pt. Townsend, Washington 98368 USA

    360-385-6021 Fax 360-385-0699 Email: tldp@olympus.net

    Medical Journalist Report of

    Innovative Biologics

    by Morton Walker, DPM

    Copyright 1999 by Dr. Morton Walker

    Freelance Communications

    484 High Ridge Road Stamford, Connecticut 06905 USA

    Phone 203-322-1551 Fax 203-322-4656

    How Polyerga? Immune Stabilizer & Biologic

    Response Modifier Helps in Cancer Management at

    Bad Wiessee’s Klinik Winnerhof and in

    Other Countries

    When in 1992, Olga Maschat, a bank teller living in Bremen, Germany, was 48 years old, her steadily increasing voice roughness and breathing difficulties finally became intolerable. Frau Maschat acknowledged that the two packs of cigarettes she had smoked daily for twenty years was a probable cause, but she remained unprepared for the histologically confirmed laryngeal cancer that became her diagnosis. Confined to one site on the glottis, her tumor was judged by X-ray examination, blood tests, manual palpation, and biopsy to be a Stage 1 (T1) squamous cell carcinoma. With standard oncological treatment, the five-year survival for a person with this condition has been declared by prior cancer statistics as better than 75 percent. The attending oncologist prescribed surgery and followup chemotherapy for Frau Maschat. She did undergo cordectomy of the right vocal cord, and no metastases were observed during the operation. Followup cytotoxic therapies with the chemicals cisplatin and 5-fluorouracil, produced various side effects which kept her uncomfortable for twelve months. The patient continued uneventfully for five years thereafter without recurrence, so her doctors judged that a “cure” had been achieved. But the advisers were wrong!

    Although Olga Maschat had not resumed smoking, by May 1998 again a worsening hoarseness and breathing problem caused her to go through another biopsy of the voice box. New detection and excision of the recurrent malignant tumor thus occurred for a second time. This time, rather than go through chemotherapy, Olga Maschat decided to become one of the first patients hospitalized at a newly established health care facility exclusively dedicated to complementary and alternative medicine (CAM). Klinik Winnerhof (see Photograph 1), located in Bad Wiessee, a village in the Bavarian Alps, 50 kilometers (km) south of Munich, is a fifty-five-bed hospital and clinic devoted to therapies for degenerative diseases, especially cancer. This CAM treatment center was opened June 1, 1998 by oncologist and cardiovascular specialist Kristian Kuhlmey, MD, its current medical director and hospital administrator (see Photograph 2). Along with a variety of other natural and nontoxic therapies, Dr. med. Kuhlmey immediately started Olga Maschat on subcutaneous (SC) injections of the immune stabilizer/biologic response modifier known as Polyerga?, a pure

    extract of porcine (pig) spleen. Such SC injections of one milliliter (1 ml) each were given to the patient twice daily at first; then once daily; and eventually they were spread out to three times per week. Polyerga? therapy was continued for the patient in this manner for a year. No surgery, chemotherapy, or radiation therapy had been used, but Frau Maschat’s larygeal carcinoma did not worsen. The patient’s cancer markers fell to normal, indicating that her immune system had stabilized and beneficial biological response modification was setting in. Until today, 1 ml of subcutaneous Polyerga? per week plus 100 mg of oral Polyerga? in tablet form has been continued for this patient. Her hoarseness is gone, breathing is easy, and she enjoys a high quality of life in all respects.

Polyerga? Promotes Remission of Stomach Cancer

    During the fall of 1990, Franz Lindner, 81 years old and retired as a high school principal in the Hanover, Germany public school system, was experiencing gradually worsening pain in the low back, chest, and upper abdomen. Over time, Herr Lindner also developed symptoms similar to hiatal hernia or peptic ulcer, namely nausea, heartburn and indigestion aggravated by eating almost any food. He self-treated his discomforts with antacids which offered some temporary relief but not much. Simultaneously black stools appeared, and he then went through a period of appetite loss, feelings of fullness after even a small meal, and weight loss.

    When, in early 1991, the man’s weight fell by more than 10% of his usual body weight, Herr Lindner consulted a Hanover gastroenterologist who

    conducted laboratory tests plus X-ray and clinical examinations. The patient showed blood in his stools, anemia from gastrointestinal bleeding, a high level of carcinoembryonic antigen (CEA), an elevated amount of serum ferritin, and achlorhydria. Roentgenological examination of the upper gastrointestinal tract uncovered a large ulcer-like lesion. On palpation, he exhibited enlarged lymph nodes above the left collarbone (supraclavicular node), nodal masses around the rectum, an oversized liver (hepatomegaly), and increased abdominal fluid (ascites). A gastroscopic examination resulted in the patient being diagnosed with carcinoma of the stomach.

    One month later Franz Lindner underwent an exploratory gastric surgery in which the surgeons observed a walnut-sized neoplasm present. They took specimens for biopsy, and the subsequent diagnosed malignancy was judged inoperable. No

     80 TOWNSEND LETTER for DOCTORS & PATIENTS NOVEMBER 1999

     Polyerga?

    liver metastases could be found. Although Dr. med. Kristian Kuhlmey had not yet established Klinik Winnerhof, he was then already known throughout Germany for applying cancer therapies which encompass CAM methods. Herr Lindner preferred this wholistic-type nontoxic therapy and therefore consulted Dr. Kuhlmey at another treatment facility, also in Bavaria.

    Today, Dr. med. Kuhlmey’s anticancer procedures are recognized as being unique and highly successful. For example, during the week of August 1,

    1999, the largest and most prominent clinical laboratory in Munich requested that it be allowed to undertake a joint research project with the Klinik Winnerhof staff to determine why their clinic’s cancer patients develop such elevated blood serum levels of phagocytes, macrophages, lymphocytes, T-suppressor cells plus T-helper cells, and associated homeostatic cellular ratios of the immune system.

    From day one of Franz Lindner’s consultation with Dr. med. Kuhlmey, he received twice-daily SC injections of 1 ml of Polyerga?. When, after four

    weeks, he was released from the oncologist’s care with normal cancer marker tests, Polyerga? treatment was still continued by Herr Lindner on his own at home. He gave himself a 1-ml SC injection into the abdominal area every other day for twenty days; then for one year he injected 1 ml of the drug twice per week. Later dosage reduction was made to 1 ml per week for another year.

     Also as part of his usual daily nutritional supplementation, Franz Lindner took one Polyerga? tablet three times a day with meals. Each tablet contained a dosage of 100 mg of porcine spleen oligo- and polypeptides. If he was inclined to utilize Polyerga? capsules instead, Herr Lindner would have been receiving 100 mcg of porcine spleen glycopeptides, recommended to be taken as a single capsule once every other day with meals. (The product is manufactured in two oral forms, capsules and tablets.)

    No chemotherapy had ever been administered to Franz Lindner. He eventually did die in 1998 at age 89 but not from stomach cancer. That malignant condition he had survived without difficulty. Rather, Herr Lindner succumbed to complications associated with the trauma of his falling from horseback while out riding with his great grandchildren.

Defining the Peptide Stabilizers in Porcine Spleen Polyerga?

    What are the ingredients present in Polyerga? that had restored health to elderly Franz Lindner, and to Frau Olga Maschat? The vital substances are peptide factors, molecular chains of amino acids, which are constituents of every animal organ. Comprised of the tiniest of protein molecules which biochemists and physiologists call peptides, those certain protein growth factors present in porcine (pork) spleen possess beneficial characteristics for the

    treatment of cancer and other degenerative diseases in animals other than pigs and in humans. 24A dalton (Da) is equivalent to 1.657 X 10 gm. Porcine spleen peptides, which comprise the therapeutic components of Polyerga?, are of a low

    molecular weight (up to 1,500 Da) and, on hydrolysis, yield up to a maximum of one hundred sequential peptide molecules. Although scientists

     have so far been unable to determine their sequence, these peptides are comprised of up to ten amino acids in a chain, which defines them as a oligopeptide.

    Peptide growth factors in nearly all animal organs form by loss of water from the NH2 and COOH molecular groups of adjacent amino acids and are additionally referred to by biochemists as di-, tri-, tetra-, etc. peptides, depending on the number of amino acids in the molecule. Thus peptides come

    together as polypeptides, larger in size than a peptide, but smaller than a protein. They form by the partial breakdown of proteins or by connecting amino acids into chains and make up the constituent parts of proteins.

    According to which of the various scientific disciplines are being queried, different names exist for peptide growth factors. Historically, for instance, immunologists have named their growth factor-types “interleukins,” “lymphokines,” or “cytokines”; cell biologists have called members of their identified

    growth factor-type sets of molecules “growth factors”; while hematologists have used the growth factor-type descriptive term “colony stimulating factors” (CSF). However, the present generally delineating nomenclature for peptides is “growth factors,” and the term has been and is now widely used throughout the world’s scientific literature.

    The growth factor term is applied consistently among most scientific and medical disciplines because in nearly every case it reflects the context of the original discovery or isolation of any peptide. Since essentially all of these many molecules are multifunctional, it’s not easy to conceive of unique new names for them that would be entirely satisfactory; almost all of them are “panregulins,” that is they react as universal regulators or stabilizers of the 1 particular organ from which they derive.

    In this case, Polyerga? is just such a panregulin purified and processed in a patented unique manner from the spleen of the pig. The product has shown itself to be a stabilizer of the immune system. For the animal and human body, panregulins as peptide growth factors are physiological symbols for 2the transfer of signals or a kind of language of biological regulation/stabilization.

    Graph I (Berressem 1995):

     Polyerga? Used in Breast Cancer:

    A Controlled, Open Study Following tumor-specific pre-treatment, 158 breast cancer (mamma CA) patients were assigned alternately to receive 1 ml three times per week of Polyerga? (Group A with 79 patients) or to receive nutrients (control Group B with 79 patients) over a period of six weeks. At the trial’s conclusion, the lymphocyte counts, the Multi-test Merieux, the Zerssen Index, and the Karnofsky Index were significantly improved for the patients in Group A who were treated with Polyerga?. The diagram depicted here shows the percentage improvement of Group A compared with the control Group B.

     continued on page 83 >

     TOWNSEND LETTER for DOCTORS & PATIENTS - NOVEMBER 1999 81

     Photograph 1: Shown is Bad Wiessee’s KLINIK WINNERHOF, the private clinic and 55-bed hospital located in the Bavarian Alps, 50

kilometers south of Munich, Germany. The staff at KLINIK WINNERHOF is devoted to internal medicine and natural oncological therapies which encompass nontoxic complementary and alternative medical practices. Photograph 2: Seen here is Klinik Winnerhof hospital administrator and medical director Kristian Kuhlmey, M.D., a specialist in internal medicine, cardiology, emergency medicine, and oncology. With his father, Walter Kuhlmey, M.D., Ph.D. (see the caption under Photograph C), Dr. Kristian Kuhlmey is a developer of the immune stabilizer and biologic response modifier, Polyerga?, which he uses as one of his many natural and nontoxic cancer therapies. Photograph 5: Shown here (on the left) is the chief pharmacist and production manager of HorFerVit Pharma GmbH, Dr. Martin Klingmueller, Rer ter. Nat., and (on the right) the company’s chief financial officer and president, Dr. Jurgen Kuhlmey, B. Ecc., M. Sc., Ph. D. Both of these executives continue with the research and sales of Polyerga?. Photograph 6: Depicted is the freeze-drying apparatus used to isolate active substances among the 100 peptides and ten amino acids of porcine spleen used in producing Polyerga?.

     Photograph 7: Shown are cancer cell cultures utilized in vitro and in vivo for preclinical and clinical experiments with Polyerga?.

    More photos page 91 >

    82 TOWNSEND LETTER for DOCTORS & PATIENTS NOVEMBER 1999

     Polyerga?

    Peptides often promote cell growth, but they also can inhibit it; moreover they stabilize many critical cellular functions, such as in the control of cell differentiation and other processes which have little to do with growth itself. All peptide growth factors act in sets. To understand their actions, one must always consider the biological context in which they act.

    Peptide growth factors provide an essential means for each cell to communicate with its immediate environment. They ensure that there is proper local homeostatic balance between the numerous cells that comprise a tissue or organ. Since a cell must adjust its behavior to changes in its environment, the cell needs mechanisms to provide this adaptation. The tissue cells either singularly or collectively, therefore, use sets of peptide growth factors as signaling molecules to communicate with each other and to alter their own behavior to respond appropriately to their biological context. Such signaling within the confines of an individual’s immune system encourages homeostatic stabilization.

    The peptide growth factors of pig spleen that make up Polyerga? act by binding to functional receptors which transduce their signals, and the peptides themselves may be viewed as bifunctional molecules. Three main responses or actions that pig spleen peptide growth factors accomplish are:

    (a) They possess an afferent function in that there is the conveying of information to cellular receptors, providing them with information from outside the animal or human organism’s cell, tissue, or organ.

    (b) They have an efferent function in that there is the inception of any latent biochemical activity of the receptor.

    (c) They offer up physiological symbols of communication within the organ systems of nearly all animal and human organisms.

    These peptides possess the unique action of serving as a significant means to convey information from one cell to another or from one organ to the next, including the brain and central nervous system, and their action in this regard is contextual, meaning that they weave together the person’s organ actions even in the presence of a degenerative disease such as cancer.

Pig Spleen Peptides Improve the Quality of Life for Cancer Patients

    Manufactured under the Polyerga? brand name, peptides of low molecular weight taken from the pig spleen improve immune system reactivity and

    the quality of life for patients suffering from malignancies. This circumstance was especially apparent in 158 breast cancer patients who were losing weight and failing after pretreatment with standard oncological therapies. The patients definitely had shown a decreased performance status and suppressed immunological parameters. Administering Polyerga? to them stabilized the patients’ immune systems so well that their appetites improved to the point that all of them regained lost weight, restored their immunoreactivity, and caused them to experience a measureable increase in the release of 3their impaired mitogen-induced gamma-interferon (g-IFN) by peripheral blood lymphocytes.

    Immune system stabilization by use of Polyerga? was proven by the three oncologists in 1995 at Klinik Sonnenblick located in Marburg, Germany when they divided 158 breast cancer patients in an open controlled trial into two groups. The women in Group A were administered one ml of the described porcine spleen low molecular weight glycopeptide extract by SC injection three times per week. They received no other anticancer or immune medication. In comparison, other breast cancer patients in Group B were administered vitamins and minerals only. Before this study began, the immunoreactivity of the patients was suppressed, and all of them were recorded as at least 20% underweight. Various parameters were measured for these two groups, but the patients treated with Polyerga? improved far in excess of the controls (see Graph I Berressem1995).

    In the Polyerga?-treated Group A, the patients’ percentage of blood lymphocytes, Merieux skin tests, Karnofsky performance status, and sense of 4well-being increased significantly more as compared to the control Group B.

    Working together with his now deceased physician/chemist father, Walter Kuhlmey, MD, PhD, and his brother, Jurgen Kuhlmey, B. Ecc, MSc, PhD (who actively manages their HorFerVit Pharma company), Dr. med. Kristian Kuhlmey had perfected the therapeusis of Polyerga? which yields the above-described oligopeptides GP-1. As mentioned, these peptides are both immune stabilizers and biologic response modifiers.

    In laboratory investigations, the Polyerga? peptides have been proven to increase the survival rate of mice which had been infected with the influenza 56A virus (see Graph II van’t Veen 1996) as well as for relieving the suffering of chronic hepatitis B.

    Applied for the improvement of the quality of life in head and neck cancer patients while they were receiving chemotherapy with 5-FU and cisplatin derivations, Polyerga? became good supportive treatment. Proof of this support manifested itself in a randomized, placebo-controlled, double-blind clinical study conducted on 40 participating patients. Twenty of them received the 1 ml SC injections of Polyerga? and another twenty received SC injections merely containing placebo. During their chemo treatment, lymphocyte counts of the group of Polyerga?-treated patients stabilized significantly. In comparing the two groups, the investigators confirmed that their placebo-treated patients did not stabilize at all (see Graph III Borghardt 1995, 7Lindemann 1998c).

    Moreover, the chemically pretreated patients experience a lessening of fatigue and greater elevation of their energy levels when given SC injections of the pig spleen peptides (see Graph IV Borghardt 1995, Lindemann 1998c).

The Immune Stabilizing Effects of Polyerga?

    In German clinical practice at Bad Wiessee’s Klinik Winnerhof, Polyerga? is employed to (a) regulate the cancer patients’ immune systems, (b) raise their survival ability, (c) enhance their quality of life, and (d) improve their compliance with radiation therapy or chemotherapy when such a modality is needed. All of these beneficial effects actually are manifestations of the patients’ immune stabilizing responses to Polyerga?.

    Definitely observed by the clinical oncologists who are working with cancer patients from day-to-day is that the Polyerga? peptides: act as suppressors of tumor cell growth,

     stimulate lymphocyte proliferation,

     excite lymphocyte response,

     elevate immune status for patients pretreated with chemotherapy,

     continued on page 85 >

     TOWNSEND LETTER for DOCTORS & PATIENTS NOVEMBER 1999 83

    Polyerga?

Serendipitous Discovery of the Polyerga? Anticancer Effect

    By the mid-1930s, Prof./Dr. med. Walter Kuhlmey, MD, PhD, was already well-established as an oncological researcher and clinician in the medical facilities of the most famous German surgeon of his day, Professor/Dr. med. Ferdinand Sauerbruch, MD. Dr. Sauerbruch, known as “the master surgeon”

    (which was the title of his self-published autobiography), had invented the pressure chamber, an apparatus that saved countless lives in the field of chest surgery. He took in only the most brilliant medical scholars to work in his vast clinic and hospital.

    After achieving all that he had wanted as a clinician studying under “the master surgeon,” Dr. med. Walter Kuhlmey turned his attention to drug manufacturing in his own factory in Berlin. He specialized in producing insulin for the medical needs of German diabetics. After World War II began, Dr. med. Kuhlmey was ordered by the government to move his pharmaceutical plant to Oldenburg where multiple slaughterhouses were located. They could furnish him with domestic animal organs. Upon his plant being bombed and burned to the ground in 1944, he was forced to close down and await the war’s end.

    Then, he again built a pharmaceutical enterprise, specializing in insulin production. But sources of pancreas tissues were difficult to come by simply because during the postwar period there was a shortage of domestic animals, especially pigs. Subsequently, the senior Dr. Kuhlmey attempted to produce insulin from other animal organs, specifically from the spleen of calves (bovine) and pigs (porcine). Pig spleen peptides evolved as a semi-substitute source of insulin which caused no adverse reactions when he experimented with them on his own body. Instead, the pig spleen peptides offered pain relief, a sense of wellbeing, more energy, and less fatigue. He named his new product, Polyerga? (from the Latin, poly means “multiple” and erga refers to “power” or “potent”).

    In 1951, Julia Meir, a 60 year-old patient with far advanced pancreatic cancer was being treated by the Oldenburg oncological surgeon, Heinrich Pophanken, MD. Frau Meir’s tumor, five centimeters (cm) in diameter, bulkier than a hen’s egg, and situated inaccessibly on the pancreas, could not be removed even though a surgical incision had been made. Her case considered hopeless, with death expected within days, Dr. Pophanken merely closed the patient’s incision without touching the tumor. He then asked Dr. med. Walter Kuhlmey to inject the patient with Polyerga? in order to ease her pain, lift fatigue, and stimulate a feeling of wellbeing.

    Over four months with only minor interruptions, Dr. Kuhlmey administered to Frau Meir three to six intramuscular injections per week of Polyerga?; and during the next two months he reduced the dosage to just two injections a week. Surprising to everyone who knew the woman’s circumstances, this

    treatment allowed her to live a good quality of life for three years longer than expected. She had gained weight by restoration of her appetite, was cheerful during the entire period of convalescence, joined into family activities, and performed usual household chores as a wife and mother.

    In June 1954, the patient fell ill with acute ileus, from which she died immediately after undergoing an operation to correct this new condition. At the autopsy, no more tumor tissue of any kind was found. Instead, her pancreatic cancer had resolved, leaving no sign of its having been present except for extensive scarring on the organ. Such a serendipitous discovery was the beginning of looking at Polyerga? as a treatment for malignancies of all types. Biochemical research was the primary interest of Dr. med. Walter Kuhlmey but he also taught medical students. In 1954, the Medical University of Madrid invited him to be visiting professor of biochemical medicine, and he remained in that position for four years. While the University provided a small stipend for his research, it was financially supported mainly by his wife’s management of their company, HorFerVit Pharma GmbH (to explain Frau Grit Kuhlmey’s role, see the caption under Photograph 4).

    Photograph 3: Shown here is Germany’s pioneer in complementary and alternative medicine (CAM), Walter Kuhlmey, MD, PhD. A biochemist as well as a medical doctor, Professor/Dr. med. Walter Kuhlmey was the discoverer of Polyerga? and founder of this immune stabilizer’s

    manufacturing company, HorFerVit Pharma GmbH, located in Oldenburg, Germany. He was born in Berlin in 1899 and died from heart failure in Oldenburg in 1984.

    Two sons, Kristian and Jurgen, have participated with their father and mother to research and develop medical products against cancer. They built not only HorFerVit Pharma GmbH but also its sister production company, Idosan Pharma GmbH (see Photographs 5-11). Using sophisticated equipment, the trained scientific staff under this Kuhlmey family’s supervision, has turned out quality, safe, adjunctive, and supportive cancer therapies. Their products take the form of organ extracts packaged as ampoules, tablets, and capsules, with the porcine spleen peptide formulation, Polyerga?, as their companies’

    major product.

     84 TOWNSEND LETTER for DOCTORS & PATIENTS - NOVEMBER 1999

    Polyerga?

reduce melanoma lung metastases in particular.

     Under supervision by the Food and Drug Administration of Germany, Polyerga? is backed by additional randomized, controlled, double-blind clinical studies on patients and by numbers of laboratory experiments on animals (see the studies conducted internationally which are described below).

Clinical Studies of Polyerga? Conducted in Two Balkan Countries

    At the Department of Experimental Biology and Medicine of the Rudjer Boskovic Institute located in Zagreb, Croatia, Polyerga? was applied in laboratory and clinical investigations. It decreased the number of experimental lung metastases in mice (see Graph VJurin 1995a, Jurin 1996a, Zarkovic 1998), and it was used as well as supportive treatment of tumorous patients. In their conclusion, the investigators wrote: “With Polyerga?, a pronounced 8 stimulation of the host’s immune reactivity on the one hand and a significant tumor mass reduction on the other were determined repeatedly”Next, the same group of Croatian experimenters studied the influence of chemotherapy with cyclophosphamide cytotoxic agent and/or spleen peptides on the incidence of experimental lung metastases of breast cancer in mice. They found that the oral application of Polyerga? in combination with chemotherapy was significantly more effective in reducing the number of lung metastases than the application of chemotherapy alone (see Graph V Jurin 1995a, Jurin 1996a, Zarkovic 1998). A conclusion of the researchers was, “Polyerga? preparation is active against tumor metastases, particularly if combined with the 9standard chemotherapy”

    Again at the Rudjer Boskovic Institute, another study, this one supported by the Croatian Ministry of Science and Technology, was conducted to learn if mice bearing artificial lung metastases of mammary carcinoma responded positively to Polyerga?. They did! When the porcine spleen oligopeptides were combined with a dose of chemotherapy (Endoxan 50 mg/ kg single i.p. dose) the average metastatic development was four times lower than in the control mice treated by chemotherapy alone. Compared to all of the control animals which died from their cancers within forty-two days when treated only with chemotherapy, just half of the chemo/ Polyerga?-treated mice died by the end of forty-two days (see Graph VIJurin 1995c, Jurin 1996b, Zarkovic 1998). “Thus, these results offer experimental support for the use of the porcine spleen peptides in biotherapy (or combined therapy) of cancer,” 10stated the researchers.

    In another Balkan country the Clinic of Gastroenterology Department of Internal Diseases, Medical University at “Saint Iv. Rilskii” Sofia University Hospital cooperated with the National Institute for Infectious and Parasitic Diseases, Virological Laboratory of Sofia, Bulgaria in a study of Polyerga?. This Bulgarian research was focused on the effects of low molecular weight glycoproteins from pig spleen in the treatment of ten patients with biopsy-proven chronic hepatitis B virus (HBV) showing ongoing infection replication. Intramuscular injections of Polyerga? were administered to the infected people three times per week. Also, three tablets of the pork peptides were dispensed daily for 24 weeks to these same patients. The effect on viral replication was evaluated by measuring HBV-DNA and HbeAg in serum for alanine aminotransferase (ALT).

    Graph II (van’t Veen 1996):

     Polyerga? Allows for Prolongation of Survival Following Infection with the

    Influenza-A Virus.

    Following pre-treatment with Polyerga? peptides (p.o. and i.p.), mice which had diligently been infected with the influenza-A virus (A/PRB/34 H1N1) show a considerably longer survival rate compared with the placebo.

    As a result of this treatment, in three out of the ten virally infected patients HBV-DNA became undetectable and the pathological ALT decreased. The Bulgarian investigators advised, “The effect of increasing the cytolysis shows that the Polyerga? drug is active, probably by increasing the lymphokine

    secretion and the generation of cytotoxic T-cells. The absence of side effects plus its ability to reduce viral replication and lower ALT activity even in 11patients with liver cirrhosis warrants further studies of Polyerga? as an [adjunctive] ësecond drug’ or as a drug of choice [for Hepatitis B].”

The Pork Peptide Product Studied in Canada

    At the Montreal General Hospital in Montreal, Quebec, Canada, oncologists utilized Polyerga? for 25 patients who were close to death with advanced

    cancer. These were unfortunate people for whom no other therapeutic agent had proven effective. Use of the pork peptide substance in a Phase 1-11 study was cleared by the Canadian Health Protection Branch and the hospital’s Institutional Review Board.

    The Polyerga? peptides were administered to these 25 patients by tablet three times a day and SC injection three times per week. No adverse side effects were experienced, but no significant hematological or biochemical changes were detected, except one of the patients experienced the complete stabilization of his disease.

    For these cancer patients who were close to death, the median length of survival from the start of their using Polyerga? turned out to be 102 days. The longest survivor lived for seventy-seven weeks (529 days). At the conclusion of their published paper, the doctors reported, “Polyerga? is safe but more 12studies are needed to determine its anticancer effects.”

     TOWNSEND LETTER for DOCTORS & PATIENTS - NOVEMBER 1999 85

Polyerga?

    Spanish Oncologists Use Polyerga? as a Biologic Response Modifier

    In Madrid, Spain at the Centro de Investigaciones Biologicas, CSIC, eight oncology researchers applied Polyerga? for cancer patients as a biologic

    response modifier (BMR). Reporting in Research and Experimental Medicine, the investigators sought to prove that treatment with porcine spleen

    peptides can increase the number of plaque-forming cells and rosette-forming cells, as well as improve the reduced mitogen-induced gammaIFN (g-IFN) release in peripheral blood cells from cancer patients (see Graph VIIOjeda, 1994).

    They acknowledge that “treatment with Polyerga? can increase appetite, body weight, performance status, and subjective well-being in cancer

    patients. An improvement of immunoreactivity of cancer patients during Polyerga? treatment also occurs.” Hence, in the hands of the Spanish oncologists, Polyerga? delivered a biologic response modifying effect for their patients tantamount to immune stabilization.

    Using the same sort of pig spleen peptides, these particular Spanish oncologists additionally conducted in vivo laboratory experiments. They 13undertook to prove the reported BRM-like human clinical responses of Polyerga? in laboratory mice, and they succeeded.

    Graph III (Borghardt 1995): Lymphocytes in HNC Tumors: a Randomized, Controlled, Double-Blind Study:

     Stabilization of Lymphocyte Status During Chemotherapy

    The study shown here comprised 40 patients with inoperable tumors of the head and neck, of which 20 received Polyerga? solution for injection (initially 1 mI/day subcutaneously for two weeks, then 1 ml three times per week subcutaneously for 23 weeks), and 20 patients received a placebo. In addition, four cycles of chemotherapy (cis-/ Carboplatinum and 5-FU) were performed. The patients in the Polyerga? group exhibited a lower weight loss and a significantly lower level of fatigue (p=O.O3) for the whole of the duration of therapy. Their lymphocyte ratios

    were significantly stabilized too during the chemotherapy. Furthermore, these Polyerga? patients experienced significantly higher lymphocyte counts after twenty-five weeks.

     The Attributes of Biologic Response Modifiers

    To provide functional immunological support for patients with cancerous tumors, numerous biologic response modifiers (BRMs) have been utilized by progressive oncology therapists who practice complementary and alternative medicine (CAM). BRMs and CAM are synergistic for each other with every cancer patient and his or her therapist ultimately benefiting by such synergism. BRMs are an optimal form of biological therapy.

    Based on a proven concept that the human immune system is designed to eliminate and destroy any foreign substances such as bacteria and viruses inside the body, biological therapy has come to fruition during the past decade. While difficulties may remain from the patient’s physiology not recognizing malignant cells as foreign body substances, such problems are being steadily overcome. Great strides in this direction have occurred by applying highly purified proteins which we know as peptides. They activate the immune system so it works more effectively. Interferon and interleukin-2

    have been the best known of these protein peptides, but there are dozens of other similar biological immune system enhancers as well. Nearly all biologic 14response modifiers exhibit three main attributes. The BMRs:

    (a) directly trigger or stimulate a person’s immune system,

    (b) offer tumor management by indirectly shrinking or destroying malignant growth,

    (c) advantageously modulate the activities of hormones, enzymes, and other biological components,

    (d) contribute to permanent malignancy remission.

    Graph IV (Lindemann 1998):

     Lymphocytes in HNC Tumors: a Randomized, Controlled, Double-Blind Study: Polyerga? Allows for Less Fatigue During Chemotherapy As shown here, the kinetic behavior of Polyerga? patients’ lymphocyte ratio correlates with the kinetic behavior of their fatigue level.

     86 TOWNSEND LETTER for DOCTORS & PATIENTS - NOVEMBER 1999

     Polyerga?

    American oncologist Douglas Brodie, MD, of Reno, Nevada utilizes vast numbers of BRMs for bolstering the body’s natural immune defenses against cancer. These include nutrients and other food factors, as well as hormones and special immune-modulating substances (see Table I). “My main objective over the past two decades has been to find those natural substances that most effectively enhance the immune system in its battle against cancer,” says Dr. Brodie. “When these substances are part of a comprehensive cancer treatment plan, which includes strong physical and psychological 15support, the chances of beating cancer are markedly improved.”

BRM Studies of Polyerga? Conducted in Germany

    At the Medizinische Klinik der Ruhr-Universitat of Bochum in Germany and the St. Josef Hospital in Bochum, three different biologic response modifiers, thymopentin (TP5), factor AF2, and Polyerga?, were tested and compared in 23 healthy humans and twenty-three cancer patients. Each of the BRMs significantly released gamma interferon (g-IFN), but Polyerga? influenced early T-cell and B-cell differentiation for the cancer patients. There was significant restoration of their impaired g-IFN production, which is important because it’s a key cytokine in T-cell macrophage communication. Reduction 17of g-IFN concentration as a response to the stimulatory signal causes a profound inhibition of subsequent immune reactions.

    At the LPT Laboratory of Pharmacology and Toxicology in Hamburg, Germany, a whole range of toxicological studies were conducted on Polyerga? solution prepared for injection. The LD5O in rats was determined as 3.76 b.w. intravenous milliliters per kilogram (ml/kg, corresponding to a dosage of 113 mg/kg spleen peptide). There was no toxicity up to a dose level of 2 ml/kg b.w./day during the thirteen-week treatment period. The several embryotoxicity studies showed no teratogenic properties and no mutagenic potential. The maximum therapeutic dose is at least 50 times the standard dose 18of three times 1 ml per week. Polyerga? therefore provides a wide margin of safety at the therapeutic dose levels.

    Conducted at two German tumor centers, one in Munich and the other in Oldenburg, recent clinical trials of Polyerga? for the treatment of metastasized colon cancer in 40 patients indicates that their survival was significant in patients of a single center. That’s because this was a randomized,

    placebo-controlled, double-blind study in which one group of twenty patients received Polyerga? and the other group of twenty received placebo (see Graph VIIIIlliger 1998b/Lindemann 1998b).

    In 1977, at the Krankenhaus Deisterhort (Deisterhort Hospital) in Bad Munder, Germany, two groups of twenty patients, each having stomach cancer participated in a prospective, randomized, placebo-controlled, double-blind study of Polyerga? injections. Group A received the Polyerga? treatment and Group B were the controls who received only a liver extract. Then the results of Group A and Group B were matched which revealed that the porcine spleen peptides allowed patients to survive considerably longer. In fact, among the treated patients 44% lived for at least five years compared to only 11% of the control patients (see Graph IXKlose 1977).

    The authors of this investigation wrote, “The results of the prospective randomized study justify the recommendation of Polyerga? treatment for 19carcinoma of the stomach, which should start immediately after the diagnosis.”

    By itself, Polyerga? is unable to induce lymphocyte proliferation in laboratory experiments; rather, it needs a cofactor called Concanavalin A (Con A), a phytochemical derived from the jack bean plant or Canavalia ensiformis. Con A is known to possess mitogenic activity and stimulates lymphocyte

    proliferation on its own. In an experiment carried out by Dr. Martin Klingmuller, Production Manager of HorFerVit Pharma GmbH, human lymphocytes were stimulated at a low level by Con A and Polyerga? in combination, but such stimulation was solely dependent on the concentration of Polyerga? peptides. There was strictly a dose-effect relationship (see Graph XOrganogen 1985c). This means that Polyerga? works only in combination with

    other factors and no overstimulation of the immune system can be induced. This circumstance is vital in immune therapy.

Polyerga? Eliminates Rectal Cancer in a German Patient

    Publishing in the German complementary and alternative medicine (CAM) journal, Complementary Oncology Forum & Immunobiology Forum,

    oncologist Klaus Maar, MD, of Bielefeld, a suburban town in northern Germany, presented his patient’s health history An 80 year-old former merchant seaman, Hans Kurtheimer, had become the victim of recurrent stage II rectal cancer. Classified as a Dukes’ B2 tumor, it extended through the bowel wall but had not spread to lymph nodes. Mr. Kurtheimer consulted Dr. Maar just before Easter, 1996 with symptoms typical of colorectal cancer: rectal bleeding, constipation with long and narrow stools, abdominal pain, gas, vomiting, weight loss, and weakness.

    Among other laboratory test readings, Mr. Kurtheimer’s immune system profile showed an extraordinarily low ratio of helper T-cells to suppressor T-cells. “His histological diagnosis was a differentiated tubular-growing adenocarcinoma of the rectum,” wrote Dr. Maar. “This was the recurrence of a

    rectal carcinoma, which had been operated on September 9, 1993 for resection with end-to-end anastomosis. The patient was scheduled for hospital admission to undergo an operation fixed for that Monday after Easter. I attempted to convince Mr. K that an operation was necessary, but he refused it and wished first to see if my biological treatment would be successful.”

    As it happens, 10% of all malignant tumors seen in the Western industrialized countries, including the United States and Germany, involve the colorectal region, with one third of them occurring specifically in the rectum. Taken together, colon and rectal carcinoma are second only to lung cancer 20as a cause of cancer deaths.

    About 90% of colorectal cancers come from polyps, pea-sized, mushroom-like growths protruding from the inner layer (mucosa) of the lower gastrointestinal tract. After surgery for removal of these polyps, recurrent cancer may be the ultimate cause of death in one-third of cases. And this was the likely situation for Hans Kurtheimer.

    Because of his patient’s definite refusal to undergo immediate surgery Dr. Maar was forced into using a biological therapy adapted to fit the requirements of this former merchant seaman’s immune system. He therefore commenced treatment with three particular immune stabilzing therapies: (1) daily ozone insufflation into the intestine, (2) orally administered Wobe-Mugos? proteolytic enzymes, and (3) subcutaneous injection of the Polyerga?. Dr. Maar records that by itself,

     87 TOWNSEND LETTER for DOCTORS & PATIENTS - NOVEMBER 1999

Polyerga?

Polyerga? most effectively brought about cancer remission for Herr Hans Kurtheimer.

    “In the middle of May 1996, I carried out a control rectoscopy and found that his tumour, which had been bigger than a plum, could not now be detected. Yet, a biopsy of the prior tumour had shown a medium grade, differentiated adenocarcinoma,” Dr. Maar states. “My treatment was then continued for a further four weeks; afterward it was stopped until the end of August.

    “At the beginning of September 1996, a fourteen-day interval treatment in the form described was started again [but with the discontinuance of ozone insufflation and Wobe-Mugos?.] The patient always felt very fit and mentally balanced. I carried out the control rectoscopy again in October 1996, and it showed no tumour macroscopically. Furthermore, there was now also no neoplasm detectable histologically,” says Dr. Maar. “No hyperplastic mucous membrane or indication of malignancy existed.”

    By July 1997, Hans Kurtheimer, having just turned 82 years old, felt so fit, youthful, and with a zest for life that he married again. Dr. med. Klaus Maar writes in his May 1999 CAM journal article, “Immune analyses of the patient taken during and after my Polyerga? treatment shows a constant 21improvement and stabilization of his immune system.”

Clinical Investigations in China of Polyerga? as Cancer Therapy

    Among all other countries except perhaps for Germany, China has taken the lead in clinically investigating Polyerga? as a primary natural and nontoxic treatment against cancer. For example, an entire 1998 issue of the Chinese Journal of Clinical Oncology is devoted to Polyerga? therapy. Taken from this journal (published in the Chinese language) and merely listed below, are my one-line summaries of the long article titles of 28 fully developed clinical trials. Most of the studies are single-blinded but some are double-blinded for a total of 1,471 patients.

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    Ambulating Proof of Polyerga?

    Anti-Aging Attributes

    The cost of medical research is exceedingly expensive, and her husband’s focus was entirely on investigating all aspects of Polyerga? as a remedy for the prevention and treatment of degenerative diseases, especially cancer. Frau Grit Kuhlmey, consequently, financed Dr. med. Walter Kuhlmey’s efforts by turning their company into a profitable enterprise. She achieved success by dealing with domestic animal slaughterhouses, negotiating exclusive contracts, and trading in animal organs for pharmaceutical companies. It was usual for her to confirm organ viability by making visits directly to an abattoir, examining the freshly butchered organs, buying up quantities, setting prices for trades, and making deals for resale. This is one strong woman who had functioned effectively in a man’s roughneck world and went on to accompany her husband to his lecture presentations, scientific conferences, medical meetings, and other conventions. All over the world, Frau Kuhlmey made contacts for Prof/Dr. Kuhlmey Believing totally in his work, she held

    discussions with authorities in the areas of diabetes, cancer, immune system suppression, and other degenerative diseases as they related to Polyerga?.

    Frau Kuhlmey has full confidence in the anti-aging attributes of Polyerga? that her husband invented and which her two sons utilize personally and as therapy for patients. Viewing the candid photograph of Frau Grit Kuhlmey that I snapped in her penthouse apartment in mid-summer 1999, I’m certain you would never guess that this lady is 90 years old. Well, she is! Doesn’t she look about seventy-five? Let me describe my experience upon meeting her.

    I accompanied Dr. med. Kristian Kuhlmey to his mother’s tastefully furnished home in Oldenburg, Germany, and he rang her bell. After identifying

    ourselves over her intercom system, Frau Kuhlmey sent the elevator down to fetch us and simultaneously ran down the three flights of stairs. She beat the elevator, which she never rides, simply because she requires the exercise. “Climbing up and down stairs is better for me than using my indoor bicycle,” she says. Her son and I stepped into the elevator and ascended, but before we could disembark at her apartment door, the lady had already arrived there to greet us. What is the secret of her youthfulness? “For the past 30 years, one tablet a day of 100 mg of Polyerga? is the only nutritional supplement I have taken,” states Frau Grit Kuhlmey, “and it prevents me from ever having illness of any kind.”

    Photograph 4: Depicted here is the wife of Dr. med. Walter Kuhlmey, Frau Grit Kuhlmey, who for two decades, starting in the early 1960s, was actively engaged as managing director of HorFerVit Pharma GmbH. By this woman’s efforts in running the company, her husband could bury

    himself in scientific research, university teaching, and clinical practice.

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    88 TOWNSEND LETTER for DOCTORS & PATIENTS - NOVEMBER 1999

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