Advances - quackwatch.org€¦ · become self-destructive. What causes this abnormal response...

KNTERNATKONAL KNSTliTUTE OF MEDICAL SCIENCE

HOSPITAL AND CLRNKC§ ( THE RAPHAH GROUP)

ADVANCES

ImmuStim-CAP Immunologic~/ Protocol™

I IMS

ADVANCES

1998

CENTRO MEDICO GAZCUE

INTERNATIONAL INSTITUTE OF MED]ICAL SCIENCE HOSPITAL AND CLINIC§

Immuno-Oncology Department / Diagn6sticos Inmuno-Oncol6gico

ADVANCES

Advances is a compilation of articles published by the

Institute over the years that have relevance to your

immunological health. The articles are both medical and lay

in their content and from manuscripts and peer review

jorunals.

The intent of this compilation is to not only provide

critical data to physicians and scientists but to stimulate

further and future studies.

Further as a lay person it may provide encouragement

that the day may, come when "true cures" will be developed.

Never undertake any heal th or medical program without the

direct supervision of a licensed medical doctor.

Also before beginning any program for treatment of

Chronic Degenerative Disease (CDD) you and your physician

should thouroughly investigate (1) claims (2) data of patient

treatment (3) comparison data of the proposed treatment and

known existing treatments (4) risks and adverse effects (5)

the facility where the proposed therapy is administered and

·the (6) treating physicians and staff.

There are scams, frauds and quacks which or who will

attempt to take advantage of those suffering from severe and

critical CDD'S. However with proper investigation these

pitfalls can be avoided.

While the Institute does not or will not

reject treatment protocols we will provide

inforroation~for your review and investigation.

approve or

data and

We must all remember and realize that new cutting edge

therapies are many times branded as Medical Quackery and

their inventors harassed and at times persecuted to the point

of total discreditation against the physician and the

license of the physician even to the point of jailing. These

events do not define quackery and once again with careful

investigation determinations of the difference between new

cutting edge technology versus Quackery can be made.

The critical key to future cures will only come via

openess and the willingness to share new ideas amongst

scientist and physicians.

May your undertaking be PROSPEROUS!

THE INSTITUTE

Common Law Copyright

© 1998

Immu Stim-CAP Immunological Protocol™ •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

A Therapy of Tomorrow For Today

International Institute of Medical Science Division of The Raphah Group, Ltd. c/o Centro Medico Gazcue No. 357 Bolivar Santo Domingo, Dominican Republic

ABOUT THE AUTHOR

Gregory E. Caplinger, :tvm, D.Sc., FACIP, FIAM. Director of the International Institute of Medical Science (I.I.M.S.) in the Dominican Republic.

BIOGRAPHICAL SKETCH

Dr. Gregory E. Caplinger is both a scientist and

Oncology and Immunology, both in the Dominican Republic and abroad.

In March 1994, Dr. Caplinger and his research team released the results of a new biological medication, "lmmuStim"™, for the treatment of IIlV/AIDS and Cancer. This data was published in June of 1995 in the peer review journal, "Salud Intregral".

clinical physician. It has been Dr. Caplinger's I. Immune Disorders - General Overview goal and experience through the years to combine II. Why this Protocol - Its Value relating to all

Chronic Degenerative Diseases the pure scientific research with practical clinical application. III. What is an Immunological Disorder

He is a European (British) and U.S. trained physician with his medical residency in Internal Medicine and further sub-specialties of clinical

A. Various Diseases B. The Protocol C. Where is your Health/Disease

Problem? oncology/immunology. He currently continues his IV. Why Immunology works post-graduate medical education both in Europe and A. Statistics from I.I.M.S. the United States, where he regularly attends courses at Harvard Medical School, Division of Continuing V.

B. Your Case/Illness Evaluation and Treatment Conclusion Education. His board certifications include Internal VI.

Medicine/Clinical Oncology.

In conjunction with his medical studies, Dr. Caplinger completed a Doctor of Science (D.Sc.) in Biochemistry/Immunology. It is in these disciplines that he continues his research and writing of articles.

He has published over 26 articles as primary author and written a Laboratory manual entitled "Practical and Clinical Immunology for the Classroom." He recently completed a textbook titled "Progressive Immunology" (Released in 1996).

His past and present accomplishments are noted and include the "Caribbean International Prize in Medicine" (internatio~ prize given to research scientists that have contributed vital information in the area of Medicine. He is also a member of many scientific/medical organizations where he has also held positions of leadership. Further, Dr. Caplinger has recently ( 1995-1996) been named as an entry to the national publication: International Who's Who of Contemporm:y Achievement, recognized for Excellence in Medicine and Science. Dr. Caplinger is also very active in teaching and lecturing worldwide.

Currently, Dr. Caplinger and his medical associates are continuing research in the basic sciences of

I. Immune Disorders - General Overview

The environment contains thousands of pathogenic microorganisms - viruses, bacteria, fungi and parasites. Ordinarily, we protect ourselves from infectious organisms and other harmful invaders through an elaborate network of safeguards - the host defense system. Understanding how this system functions provides the framework for studying various immune disorders.

The Host defense system:

The host defense system includes physical and chemical barriers to infection, the inflammatory response and the immune response. Physical barriers such as the skin and mucous membranes prevent invasion by most organisms. Those organisms that do penetrate this first line of defense simultaneously trigger the inflammatory and immune responses. Both responses involve cells derived from a hematopoietic stem cell in the bone marrow. The inflammatory response involves polymorphonuclear leukocytes, basophils, mast cells and platelets. The immune response primarily involves the interaction of lymphocytes (T and B) macrophages and

macrophage-like cells and their products. These cells may be circulating or may be localized in the tissues and organs of the immune system, including the thymus, lymph nodes, spleen, Peyer' s patches in the intestine and tonsils. The thymus participates in the maturation of T lymphocytes ( cell mediated immunity), here, these cells are "educated" to differentiate self and nonself. In contrast, B lymphocytes (humoral immunity) mature in the bone marrow. The key humoral effector mechanism is the complement cascade. The lymph nodes, spleen and intestinal lymphoid tissue help remove and destroy circulating antigen in the blood and lymph.

Antigens

Fundamental to an understanding of the immune response is an understanding of antigens and of the concepts of specificity and memory. An antigen is any substance that can induce an immune response. T and B lymphocytes have specific surface receptors that respond to specific antigen molecular shapes ( epitopes ). In B cells, this antigen receptor is an immunoglobulin (antibody) cell: IgD or IgM; it is sometimes referred to as a surface immunoglobulin (Sig). The T cell antigen receptor recognizes an antigen only in association with specific cell surface antigen determinants, which are known as the major histocompatibility complex (MHC). Slightly different antigen receptors can recognize a phenomenal number of distinct antigens coded for by distinct, variable region genes.

Groups, or clones, of lymphocytes exist with identical receptors for a specific antigen. The clone of lymphocytes rapidly proliferates when exposed to the specific antigen. Some of these lymphocytes further differentiate and others become memory cells which enable a more rapid response - the memory of anamnestic response - to subsequent challenge by the antigen.

Many factors mfluence antigenicity. Among them are the physical/chemical characteristics of the antigen, its relative foreignness, and the individual's genetic makeup. Most antigens are large molecules -greater than 10,000 daltons- such as proteins or

polysaccharides. (Smaller molecules, such as drugs, that aren't antigenic by themselves are known as haptens. The haptenc, can bind with larger molecules, or carriers, and become antigenic or immunolgenic.) The relative foreignness of the antigen influences the intensity of the immune response. For example, little or no immune response may follow transfusion of serum proteins between humans; however, a vigorous immune response (serum sickness) often follows transfusion of horse serum proteins to a human. Genetic makeup may also determine why some individuals respond to certain antigens while others do not. The genes responsible for this phenomenon -the immune response genes - are located within the MHC.

The Major Histocompatibility Complex

The major histocompatibility complex (MHC) is a cluster of genes on human chromosome 6 that plays a pivotal role in the immune response. Also known as human leukocyte antigen (HLA) genes, these genes are inherited in an autosomal codominant manner. That is, each individual receives one set of MHC genes (haplotype) from each parent and both sets of genes are expressed on the individual's cells. These genes play an essential role in the recognition of self versus nonself and the interaction of immunologically active cells by coding for cell-surface proteins.

HLA antigens are divided into three classes. Class I antigens appear on nearly all of the body's cells and include HLA-A, -B and -C antigens. During tissue graft rejection, they are the chief antigens recognized by the host. When killer T cells Iese a virally infected antigen, they recognize it in the context of a Class I antigen. Class II antigens only appear on B cells, macrophages and activated T cells. They include the HLA-D and-DR antigens. Class II antigens promote efficient collaboration between immunocompetent cells. T cells require that antigen be presented in the context of a Class II antigen. Because these antigens also determine whether an individual responds to a particular antigen, they're also known as immune response genes. Class III antigens include certain complement proteins (C2, C4 and Factor B).

STRUCTURE OIF THE BMMUNOGLOBULIN MOLECULE

B lymphocytes

The lg molecule consists of four polypeptide chains_;_two heavy (H) and two light (L) chains - held together by disulfide bonds. The H chain has one variable M and at least three constant (C) regions. The L chain has one V and one C region. Together. the V regions of the H and L chains form a pocket known as the antigen-binding site. This site Is located within the antigen-binding fragment (Fab) region of the molecule. Part of the C region of

B lymphocytes and their product immunoglobulin (lg) comprise humoral immunity. The binding of soluble antigen with B cell antigen receptors initiates the humoral immune response. The activated B cells differentiate into plasma cells that secrete immunoglobulins or antibodies. This response is regulated by T lymphocytes and their products, such as B cell growth factor and B cell differentiating factor.

The lg secreted by plasma cells are four-chain molecules with two heavy and two light chains. Each chain has a variable (V) region and one or more constant (C) regions coded for by separate genes. The V regions of both light and heavy chains participate in the binding of antigen. The C regions of the heavy chain provide a binding site for Fe receptors on cells and govern other mechanism such as complement activation.

Autoimmune disorder (AID)

Autoimmunity is characterized by a misdirected immun~ response in which the body's defenses

the H chains forms the crystallizable fragment (Fe) region of the molecule. This region mediates effector mechanisms, such as complement activation, •and is the part of the lg molecule bound by Fe receptors on phagocytic cells, mast cells, and basophlls. Each lg molecule also has twQ antibody-combining sttes (except the lgM molecule has ten, and lgA may have two or more).

----- Fe regton

CH3

become self-destructive. What causes this abnormal response remains puzzling. Recognition of self through the MHC is known to be of primary importance in an immune response. However, just how an immune response against self is prevented and which cells are primarily responsible, isn't well understood.

Autoimmunity likely results from a combination of factors. Characteristic of many autoimmune disorders is B cell hyperactivity marked by proliferation of B cells and autoantibodies rutd by hypergammaglo bulinemia. T cell abnormalities -especially suppressor T cell deficiency - are also common. Viruses may contribute to autoimmunity by causing proliferation (Epstein-Barr virus) or destruction (HTL V-111) of lymphocytes; so may macrophage abnormalities which interfere with processing and presentation of antigen. Hormonal and genetic factors strongly influence the incidence of autoimmune disorders. For example, lupus erythematosus predominantly affects women of childbearing age and certain HLA haplotypes are associated with increased risk of specific autoimmune disorders.

Immunodeficiency (SIF)

In immunodeficiency, the immune response 1s absent or depressed resulting in increased susceptibility to infection. This disorder~may be classified as primary or secondary. Primary Immunodeficiency reflects a defect involving T cells, B cells, or lymphoid tissues such as the thymus. Secondary Immunodeficiency results from an underlying disease or factor that depresses or blocks the immune response.

Thus, as can be seen from a 'General Overview', most diseases and specifically CDD's have a very critical immune component. Therefore, it is logical, if not critical, that all treatment programs have immunological factors in the approach to therapy.

II. Why this Protocol - It's Value relating to all Chronic Degenerative Diseases

In recent years the medical community has come to the conclusion that "most, if not all" chronic degenerative diseases have at their causal base an immunological problem.

It is our conviction at 1.1.M.S. that it is relevant that most physicians and specialty boards have reported that most, if not all CDD's have basic immunological causes. This is not to say that all CDD's are caused by Immune Disorders but there is a definite relationship.

Therefore, since our basis of treatment is lmmunotherapy, most, if not all CDD's can benefit from the Immu Stirn™ /CAP Immunological protocol.

Thus, as time progresses and we find more and more Immune related basis for CDD's, it is logical to not only treat, for example, the cardiovascular problem (high cholesterol) but also. enhance the Immune function to better the potential of a more rapid response.

One conclusion most physicians around the world have reached is that the better Immune func~ion one has, they will lead a better life even to the point that many scientists are stating that the "aging process"

can actually be reduced or, in some cases, reversed with an enhanced immune function. The Immu Stirn/CAP Immunological Protocol does just that -causes a better Immune function.

III. What is an Immunological Disorder?

An Immunological Disorder/ Disease is any health related problem that has at its root a primary dysfunction in the body's ability to defend itself and therefore causing or producing an illness.

Immunological Disorders may either be primary, secondary or tertiary, which actually indicates at what level the Immune dysfunction is affecting the disease. Obviously a primary level is one in which the Immune dysfunction can be directly linked to a disease such as mv / AIDS, etc.

A. Various Diseases

The following is a few of the better known CD D's with an Immune basis or root:

DISEASE* CASES TREATED

Multiple Sclerosis > 500 ALS 70 Severe Allergies >6000 Rheumatoid Arthritis > 350 Psoriasis 65 Chronic sinusitis > 1000 Fibrocystic Breast Disease >2500 Epstein Barr Virus >1500 Autoimmune Disease > 1000 Hypothyroidism 350 Lupus 700 Diabetes 650 Chronic Candidacies Infections > 1000 Severe Vitamin Deficiencies >2000 Asthma >2500 Various Metabolic Imbalances >2500 *These numbers do not include thousands of Cancer and lllV/AIDS patients. Further, these are cases in which the Institute has adequate data to support the findings.

B. The Protocol

The protocol consists of: 1. Parenteral treatment (IV) with the basic

Immu Stirn Formula. The carrier solution is based upon the principles of hyperalimentation or the use of essential / nonessential amino acids in 3% - 5% concentration from suppliers such as Abbott Laboratories (Aminosyn).

2. Intramuscular and subcutaneous treatment with the Immu Stirn formula.

3. Sub lingual Immu Stirn tablets. 4. Nutritional support - supplements as needed.

C. Where is your Health/Disease Problem?

To better access your Immune status and determine whether you fall within the parameters of I.I.M.S., you can request your physician to order an Immuno - Oncological Evaluation (IOE) kit with information from the Institute or schedule a visit for a 3 day evaluation.

This will access your status and the probability of us successfully treating your exact health-related disorder.

5. Appropriate dietary changes for optimum heahh 6. Exercise program. 7. Miscellaneous medicines as needed.

Many physicians and scientists have stated that the single most critical system in the body is the immune system. If and when one identifies dysfunction in the immune system, it is relatively simple to understand why and how the reparation of such will only cause all other systems to function better.

IV. Why Immunology Works

As with any therapy, treatment or approach to improving one's health, it is important to understand why.

Immunology can either be specific or non-specific. The difference is a general approach to immune stimulation and reparation, or the treatment of a specific entity within the immune system.

In simplistic terms, Immunology works either by first or second line defense as shown below: (Think of immunology as being both your house and a security system within your house.)

Skin or Mucous Membrane 1st Line Of Defense

Mutated Cell/ (Disease)

~ ~ ~

Inflammatory & Immune Response 2nd Line of Defense

Therefore, in one form or another, the body, through its functional design, stimulates the primary and secondary line of defenses against any and all foreign attacks. When our body's own defense is low, weak or non-functional, the immundtherapy takes the temporary position of primary and secondary defense systems.

A. Statistics from the Institute (I.LM.S.)

· We have previously reported that, in the area of cancer treatment, our "Five Year Survival Rate" is approximately 86%. This compared to the other forms of approved therapy ( chemo, etc.) shows, at times to be as much as 50% more efficacious when looking at the same "Five Year Survival Rate".

In the area of HIV/ AIDS, we currently are able to show tremendous results with many patients displaying no signs of the active virus.

It has been a policy of the Institute to maintain an active and reliable data base showing results from our Immunological approach to fighting disease. Further, as is scientifically appropriate, we have held to International Standards in research protocols such as: (1) IRB (2) Informed consent (3) Toxicology studies ( 4) Phase studies which include double blind studies and (5) Review (independently) of data.

B. Your Case / Illness

Each case (patient) is thoroughly evaluated individually and specifically. As with any therapy, we have our own bias (ours being immunological), and the Institute does it's best to evaluate ALL components of the illness and thus formulate the most advantageous treatment program for that patient.

If there are no notable immune factors we address the illness accordingly. In the end, the goal and objective is for the patient's health to recover to it's fullest capacity.

V. Evaluation and Treatment

A thorough evaluation needs to consist of literally all aspects of the body's function and specifically as it relates to the specific complaint or illness as defined by the patient and diagnosis. It is always the objective of the International Institute of Medical Science to discover all causal factors of the illness/ disease. Therefore, we look at the problem in the following manner:

1. Illness/ Disease -Patient Complaint(s) 2. Diagnostic Protocol

a. Molecular Evaluations b. Cellular Evaluations c. Organ Evaluations d. System Evaluations

3. Treatment Protocol a. Designed to address points A - D

above. b. Designed to stimulate and regulate

the Immunological function both generally and specifically.

c. Designed to support all existing symptoms and support the life of the patient.

d. Designed to improve the 'Quality of Life' in each patient.

VI. Conclusion

As you can see, Immunotherapy and the Immu Stirn/CAP Immunological Protocol is indeed valid in most if not all CDD's.

Further, this Institute maintains that Immunotherapy is not the "magic bullet" and only through continued research will we ever reach the day of a disease-free world or at least a world where cures exist for any and all health problems. We must all endeavor to work together toward this goal.

REFE.RENCES

• Caplinger, G.E., "Immuno-Therapy As'Primary Therapy," BWJ Press, May 1990

• Caplinger, G.E., "The Utilization of Amino Acids in the Treatment of Chronic Degenerative Disease," (Manual) 1988

° Caplinger, G.E. and Pena, Claudio, "Treatment of mv / AIDS Infected Patients with a Biological Response Modifier ImmuStim-V" Salud IntegraL Vol.I, No. 1, August 1995

• Clark, Hulda, "The Cure for IDV and AIDS," Promotion Publishing, 1993

• Kidd, Paris and Huber, Wolfgang, "Living with the AIDS Virus", HK Biomedical, 1991

• Sites et al, Basic and Clinical Immunology, Lange, 1982.

DISCLAIMER

All information and treatment originated in and from The Dominican Republic.

This information is not intended for the solicitation of patients or interested parties but is intended to disburse medical and scientific information.

CDD's, Cancer and mv / AIDS vary from person to person and so does the results. No results are, or should be considered typical or expected. As with all medicines and protocols, the results will vary from patient to patient.

ADVANCES In

Treatment for

Chronic Degenerative

Disease (CDD)

ImmuStim-CAP Immunological Protocol™

••••••••••••••••••••••••••••••••••••••••••••••• • ••••••••••••••••••••••

AN OVERVIEW OF THE PROTOCOL

ABOUT THE AUTHOR

Gregory E. Caplinger, MD, DSc, FACIP, FIAM.

BIOGRAPHICAL SKETCH

Dr. Caplinger is both a scientist and a clinical physician. It has been Dr. Caplinger's goal and experience through the years to combine the pure scientific research with practical clinical application.

He is a physician trained in both Europe (Britain) and the U.S. with medical residency in Internal Medicine and further sub-specialties of clinical oncologyimmunology. He currently continues his postgraduate medical education in both Europe and the United States, where he regularly attends courses· at Harvard Medical School, Division of Continuing Education. His board certifications include Internal Medicine in Clinical Oncology.

In conjunction with his medical studies, Dr. Caplinger completed a Doctor of Science (D.Sc) in Biochemistry/ Immunology. It is in these disciplines that he continues his research and writing of articles.

He has published over 26 articles as primary author and written a Laboratory manual entitled "Practical and Clinical Immunology for the Classroom.'' He recently completed a textbook titled "Progressive Immunology" (Released in 1996).

His past and present accomplishments are noted and include the "Caribbean International Prize in Medicine" (International prize given to research scientists that have contributed vital information in the area of Medicine. He is also a member of many scientific/medical organizations where he has also held positions of leadership. Further, Dr. Caplinger has been named ( 1995-1996) as an entry to the national publication: International Who's Who of Contemporary Achievement, noted for Excellence in Medicine and Science. Dr. Caplinger is recognized as a worldwide teacher and lecturer.

Currently, Dr. Caplinger and his medical associates are continuing research in the basic sciences of Oncology and Immunology, both in the Dominican Republic and abroad.

In March 1994, Dr. Caplinger and his research team released the results of a new biological medication, "I St' ,,TM .c. h mmu tm , 1or t e treatment of IIlV / AIDS and cancer. This data was published in June of 1995 in the peer review journal, "Salud Intregral".

I. II.

III. IV. V.

I.

The Protocol: The Basis and Value The Value of the Protocol m Various Diseases Preventative Immunotherapy The Balanced Life Conclusion

THE PROTOCOL: THE BASIS and VALUE

Over the years it has become more and more evident that many diseases, especially the chronic degenerative diseases have immunological components. 1

Many scientists have discovered that one cannot suffer from CDD unless they have an immunological system that is functioning at subnormal levels. 2

A few years ago a tribal group was discovered in the Amazon 3 and no one suffered from any CDD. It was only after outside civilization moved in that diseases involving Immune dysfunction started to appear.

'fHE BASIS OF THE PROTOCOL

The Protocol is both general and specific. It stimulates general immune function causing the system to normalize and depending on the disease entity it has components that attack the specific disease. 4

In summary: The effects of the lmmuStim .. CAP Immunological Protocol: □ Stimulate T cells and macrophages to destroy

neoplastic cells (foreign invaders). □ Stimulate cell mediated humoral and general

immunity/immune response □ Oxidize any existing Free Radical Pathogens □ Stimulate and activate NK (Natural Killer) cells

to destroy neoplastic cells and invasive organisms □ Give the needed nutritional support. □ Improve the general quality of life.

Immunotherapy in reality is not new, but ImmuStimCAP Immunological Protocol is revised or enhanced to better deal with the multifaceted nature of cancer and degenerative diseases.

Further, Immunotherapy such as ImmuStim-CAP Immunological Protocol now utilizes the vaccines of past years (ie. Polio, TB) and employs various new innovative methods to affect both general and specific immune stimulation.

PROTOCOL

The protocol consists of:5

I. Parenteral treatment (IV) with the basic ImmuStim Formula. The carrier solution is based upon the principles of hyperalimentation or the use of essential/ nonessential amino acids in 3% - 5% concentration from suppliers such as Abbott Laboratories (Aminosyn).

2. Intramuscular and subcutaneous treatment with the ImmuStim formula.

3. Sub lingual ImmuStim tablets. 4. Nutritional support - supplements as needed. 5. Appropriate dietary changes for optimum health 6. Exercise program. 7. Miscellaneous medicines as needed.

VALUE

The National Cancer Institute and the National Institute of Health have proved that those persons with normal immune systems suffer from less CDD and live an average of 15 years longer than those with immune deficiencies.

II. THE VALUE OF THE PROTOCOL IN VARIOUS DISEASES

Once again, if a person has a CDD with an immune deficiency the protocol has proven to be efficacious.

During the last five years our various centers and associates have treated the following diseases with this protocol This list is not all-inclusive because it does not include our cancer and IilV / AIDS patients.

These numbers are approximate (plus or minus 5%):

DISEASE*

Multiple Sclerosis ALS Severe Allergies Rheumatoid Arthritis Psoriasis Chronic sinusitis Fibrocystic Breast Disease Epstein Barr Virus Autoimmune Disease Hypothyroidism Lupus Diabetes Chronic Candidiasis Infections Severe Vitamin Deficiencies Asthma Various Metabolic Imbalances

CASES

> 500 70

>6000 > 350

65 >1000 >2500 >1500 >1000

350 700 650

>1000 >2000 >2500 >2500

* These numbers do not include thousands of Cancer and IDV / AIDS patients.

III. PREVENTATIVE IMMUNOTHERAPY

Much like any preventive measure, the immune system is no different. Due to our ultra modem cutting-edge immunology laboratory, we are able to detect physical problems before they reach the disease-state.

It is the belief of the International Institute of Medical Science that with proper diagnostics most, if not all CDD' s can be prevented by making immunological changes in the early stages of the disease. People come to us for just that reason; a comprehensive three day immunological evaluation.

The days of yearly physicals should be over because they only detect an existing disease and do nothing to stop our negative health trends.

IV. THE BALANCED LIFE

The so-called extreme life styles led by many on both ends of the spectrum have their own problems. To carelessly ignore the importance of a good diet and exercise is foolish and yet, one cannot have a , meaningful life if it is spent entirely in the gymnasium or over a juicer.

We propose the following balance:

SPIRITUAL

Balanced Diet

Exercise

Good management of stres.c;

PHYSICAL EMOTIONAL

Regardless of the diagnosis and the appearance of the medical facts, if a person has a will to live, they stand a better chance for remission and/ or a cure. Never should a doctor assume that a patient's condition is hopeless - no matter what the odds are.

It is our position that we always keep an open mind and give positive support while instilling realistic hope.

APPROACH TO CDD

As we have stated above, the approach here is one of balance. Therefore, when a patient arrives at one of our facilities the process is extensive in regards to both the evaluation and treatment phases. The normal visit consists of the following:

EVALUATION -1. Intake interview. 2. Complete patient history. 3. Complete physical examination. 4. Laboratory evaluations which evaluate

literally every chemical, cell, DNA, RNA, vitamin, and mineral in your body. This will reveal the exact status of one's health and immune system.

TREATMENT-!. Administration of the ImmuStim CAP

Immunological Protocol (as basis). 2. Additional medicines as needed. 3. Nutritional support - vitamin and mineral

supplementation. 4. Exercise program. 5. Dietary program

WHAT TO EXPECT*

Depending upon the condition of the ambulatory p~tient, the general course of therapy is as follows:

Visit# I 2 3 4 5 6

Duration 14-21 7-14 5-10

5 5-7

7

Days before next visit 30-60 60-120 90-180

180 180 180

7 Begin Maintenance Phase.

• The above data shows averages for all CDD's that we have treated and should not be considered typical for all patients

Because of our advanced technology, we generally can place a value on how well a patient is responding to ImmuStim within 72 hours after the start of treatment.

FOLLOW-UP

Depending upon the severity of the COD and the long-term prognosis, return visits for additional treatment are scheduled as needed.

As an additional service to the patient, we establish a relationship with your local physician( s) so that a coordinated effort is achieved when moving toward recovery. We also have a network of physicians in the U.S.A and various countries that are able to follow your particular case.

V. CONCLUSION

It has recently been established that many diseases are related to Immunological deficiencies. 8

· ImmuStim addresses the deficiencies in ones immune system as it strives to keep the body disease free.

This is a general overview of the protocol and related treatment, therefore, there are many areas that have not been covered in this writing. For further information please contact us by telephone or telefax.

REFERENCES

• Caplinger, G.E., "Immuno-Therapy As Primary Therapy," BWI Press, May 1990

• Caplinger, G.E., ''The Utilization of Amino Acids in the Treatment of Chronic Degenerative Disease," (Manual) 1988

• Caplinger, G.E. and Pena, Claudio, "Treatment of 1-IlV/AIDS Infected Patients with a Biological Response Modifier lmmuStim-V" Salud Integral, Vol.I, No. 1, August 1995

• Clark, Hulda, "The Cure for 1-IlV and AIDS," Promotion Publishing, 1993


• Sites et al, Basic and Clinical Imunology, Lange, 1982.

DISCLAIMER



CDD's, Cancer and mv / AIDS vary from person to person and so does the results. No results are, or should be considered typical or expected. As with all medicines and protocols, the results will vary from patient to patient.

ADVANCES In

Oncological

(Cancer) Treatment

ImmuStim-CA/CAP Immunological Protocol™ SHOWS EXTREME EFFICACY in CANCER TREATMENT

UPDATE 1998

IMMUNOTHERAPY AS THERAPY OF CHOICE

NOTE TO THE READER

The following article is neither medical / scientific nor written for the lay person. It is not written as a peer review article but it is written to provoke, challenge and make physicians, scientists and patients aware of the advantages of Immunotherapy which is approved by all major cancer authorities as an approved treatment for cancer.

ABOUT THE AUTHOR

Gregory E. Caplinger, MD, DSc., FACIP, FIAM.

BIOGRAPHICAL SKETCH

Dr. Gregory E. Caplinger is both a scientist and clinical physician. It bas been Dr. Caplinger's goal and experience through the years to combine the pure scientific research with practical clinical application.

He is a European (British) and U.S. trained physician with his medical residency in Internal Medicine and further sub-specialties of clinical oncology/immunology. He currently continues his post-graduate medical education both in Europe and the United States, where he regularly attends courses at Harvard Medical School, Division of Continuing Education. His board certifications include Internal Medicine/Clinical Oncology.


He has published over 26 articles as primary author and written a Laboratory manual entitled "Practical and Clinical Immunology for the Classroom." He has also completed a textbook titled "Progressive Immunology" (Released in 1996).

His past and present accomplishments are noted and include the "Caribbean International Prize in Medicine" (international prize given to research scientists that have contributed vital information in the area of Medicine. He is also a member of many scientific/medical organizations where he has also held positions of leadership. Further, Dr. Caplinger was recently ( 1995-1996) named as an entry to the national publication: International Who's Who of Contemporary Achievement, recognized for Excellence in Medicine and Science. Dr. Caplinger is also very active in teaching. and lecturing worldwide.


In March 1994, Dr. Caplinger and his research team released the results of a new biological medication, "IrnmuStim"TM, for the treatment of HIV/AIDS and Cancer. This data was published in June of 1995 in the peer review journal, "Salud Intregral".

I. BASIS OF ALL CHRONIC DEGENERATIVE DISEASE

II. IMMUNO-THERAPY - NEW OR REVISED

III. NEW DIAGNOSTICS IN ONCOLOGY AND CHRONIC DEGENERATIVE DISEASES

IV. CHEMOTHERAPY AND RADIATION ARE IMMUNO-SUPPRESSIVE

V. IMMUNOTHERAPY -THE BASIS VI. IMMUNO-THERAPY AS PRIMARY

THERAPY IN ONCOLOGY VII. ONE HUNDRED CASE STUDIES

(SUMMARY) Vlll. THE FUTURE OF CANCER IX. AFTERTHOUGHTS

I. BASIS OF ALL CHRONIC DEGENERATIVE DISEASE

Over the many years of cancer research and therapy, there are still many debates as to the cause or casual

factors of cancer. Much research and subsequent therapy has been directed towards a specific cause of a specific cancer.

Dr. Caplinger, et al., believes that a common biochemical phenomena exists with all malignancies which has been previously shown by the Nobel laureate, Dr. Otto Warburg and subsequently by NCI research scientist Dr. Dean Burke. When the cellular function, or more specifically, the mitochondria of the cell is examined, it is found to be anaerobic in the "cancer state or disease state" verses aerobic in the "healthy state".

Further, there exists Free Radical Pathogens (FRP's) which are a result of split electrons in a cancer patient or one suffering from CDD's.

Therefore, the discovery of a general immunological protocol with specific action has been utilized in over seven thousand cancer patients (mixed). The use of ImmuStim-CA/CAP Immunological Protocol has demonstrated a significant efficacy in most concerns.

In light of new research and data from our collaborators in the ImmuStim CAP Immunological Protocol, the approach has bee slightly modified to effectively address the key "Biological cofactors" which are:

1. Mycoplasma (parasite-parasitic) 2. Pleomorphic organisms related to No. 1 3. Removal of pre-cancerous growth factors

which stimulate cellular mutation.

As many have postulated, the ultimate expression of chronic degeneration may well be "Cancer".

II. IMMUNOTHERAPY - NEW OR REVISED

When utilizing an immunological treatment program, it is vital to fully understand the nature of the immunological approach. In general, there are two separate and yet effective approaches. One is to treat specifically where the therapy is directed towards an area of the immune system and the other

is to treat generally whereby one stimulates the entire immunological system.

Most approaches to immunological therapy are directed towards augmentation of the White Blood Cells (WBC's). The specific action oflmmuStim is to augment, regulate, stimulate and direct the WBC 's, stimulate Tumor Infiltrating Lympnocytes (TIL's), increase and activate Natural Killer Cells (NK's), affect function and levels ofT and B cells, and cause a general activation and stimulation of the immune system. This is done to produce an immunological response to effectively react to various immunological diseases such as: Cancer, IIlV / AIDS, Epstein-Barr virus, Chronic Fatigue Syndrome, allergies and other immunological dysfunctions.

It is important to understand that ImmuStim is a medication that may be used in conjunction with other therapies.

Much attention to date, as previously noted, has been the search for specific causes of specific cancers. Neoplastic cells differ from normal cells in size and function. As proposed by Warburg, they are anaerobic and as proposed by others, they contain FRP' s and thus, unpaired electrons.

Over many years of cancer research, the Americans and subsequently, the international community, have found four efficacious forms of therapy:(!) Surgery, (2) chemotherapy, (3) Radiation, ( 4) Immunotherapy.

Many clinicians and scientists feel that lmmunotherapy not only is effective, but also, in comparison very non-toxic.

The approach of Caplinger, et al. is that of nonspecific immunostimulation with specific anticarcinogenic activity. The use of lmmuStim-CA/CAP Immunological Protocol uses biological agents to stimulate the body's reticuloendothelial system, augmenting the patient's own immunosurveillance and combating the immunosuppressive effects of cancer and its treatment.

As a major biological component of the medicine, Interleukin-2 (IL2) not only serves as a general immune stimulant but also activates TIL' s (Tumor

r

Infiltrating Lymphocytes) which act as macrophages to attack and eliminate neoplastic cells.

To summarize the effects of the lmmuStim-CA/CAP Immunological Protocol: □ Stimulate T cells and macrophages to destroy

neoplastic cells. □ Stimulate cell mediated humoral and general

immunity/immune response □ Oxidize any existing Free Radical Pathogens

Stimulate and activate NK (Natural Killer) cells to destroy neoplastic cells

□ Give the needed nutritional support. Improve the general quality of life.

Immunotherapy in reality is not new, but lmmuStimCA/CAP Immunological Protocol is revised or enhanced to better deal with the multifaceted nature of cancer and degenerative diseases.

Further, immunotherapy such as ImmuStimCA/CAP Immunological Protocol now utilizes the vaccines of past years (ie. Polio, TB) and employs various new innovative methods to affect both general and specific immune stimulation.

III. NEW DIAGNOSTICS IN ONCOLOGY AND CHRONIC DEGENERATIVE DISEASES

As we approach newer, effective and more curative programs of treatment, we need methods of diagnosis that will advise us of the so-called "precancer" state in order to properly change and avoid the impending disease-state.

While there is not one specific blood test, laboratory study or body scan for detecting cancer, there are, according to Caplinger, et al., a series of studies that may then be ''mathematically crunched" to give a probability of cancer. This probability, while not diagnostic, does provide valuable observations in regards to: (A) general cellular changes that give rise to cancer cells (B) evaluation of various tumor markers that indicate either an existing malignancy or the possibility of such, (C) chemical conditions that are present in cancer patients/conditions and

(D) oxidative changes that are associated with malignancy.

These various studies, many of which are routine, combined with medical microscopy (Bradford et al. -American Biologics) may very well be the cancer predictors of the future.

As we approach the year 2000, it becomes more and more important to not only search for the cure but also the method to detect and thus avoid causal factors prior to the disease.

IV. CHEMOTHERAPY AND RADIATION -IMMUNOSUPPRESSIVE

Even though Billions of dollars have been spent on Cancer Research, according to the NCI and the International Cancer studies, the cases of cancer have increased both morbidity and mortality. This does not speak well of the existing therapies. The "Five Year Survival Rate" of chemotherapy and radiotherapy is approximately 31 % according to the American Cancer Society (mixed cancer- aJl types). The three year rate is basically the same or sl1ghtly lower.

IMMUNOSUPPRESSIVE

According to the cancer experts (NCI, ACS, etc.), chemotherapy and radiotherapy is immunosuppressive then most if not all cancer patients have suppressed immune systems. Why do we as physicians continue to choose such an approach to treat cancer? Research is showing that a suppressed immune system leads to cancer and other CDD's.

Therefore, it is logical that the therapy or drug of choice is immunotherapy. Since this is not alternative or experimental, it is approved for cancer treatment by ACS, NCI, FDA, AMA and all international cancer bodies.

Immunotherapy is the basis of our protocol and has proven to be greater than 51 % more effective than chemotherapy and radiotherapy when looking at mixed cancers. It only makes sense to stimulate the immune system instejld of suppressing it.

V. IMMUNOTHERAPY - THE BASIS

By looking at the data it is evident that chemotherapy does not work under most conditions. Many years and billions of dollars have been spent on the research and development of replacement drugs. As a matter-of-faet, chemotherapy suppresses the immune system. While there are those who state that people have cancer while maintaining a normal immune system, it is proven that on a molecular / cellular level, that most if not all of these patients have severe immune deficiencies.

Therefore, immunotherapy is intended to build up or rebuild the immune system and enable it to fight and destroy the cancer.

There is both a general and specific immunotherapy. In this case the lmmuStim protocol is specific because it not only builds and restores the immune system but it has specific anticarcinogenic properties.

VI. IMMUNOTHERAPY AS PRIMARY THERAPY IN ONCOLOGY

Oncology, over the years, has been anything but modem in many ways when one visualizes patients that are poisoned (chemotherapy), burned (radiation) and experimented upon in an effort to cure an equally devastating condition, Cancer.

With modernization many times comes a return to basic principles. lmmunotherapy is indeed ~ or the foundation in curative treatment of malignancy.

ImmuStim-CA/CAP Immunological Protocol has shown via conclusive data its' efficacy and superiority when compared to• chemotherapy, radiation, and/or combination therapy.

One will comprehend with this follow-up the efficacy and benefits to Biological-Immunotherapy and more specifically, the use of ImmuStimCA/CAP Immunological Protocol.

Caplinger, et al., does contend that whenever surgical resection is possible, this must be approached aggressively to reduce "cancer burden".

VII. ONE HUNDRED CASE STUDIES (SUMMARY)

The patients were randomly chosen and most were in Stage ill or IV. Also, note that the number of patients treated with ImmuStim is larger than the overall average.

In comparison, only 24% of those rece1vmg chemotherapy achieved a cancer free state in 36 months as compared to 60% using the ISP. Worth noting is that 88.3% of the ISP group were either cancer free or in partial remission with a low death rate of 11.7%.

When comparing the ISP group with the standard (ASCO) recommended chemotherapy, there is solid data that shows remarkable results. Additionally, we continue to fine-tune the treatment by adding some oral medications that improves the number of patients reaching the cancer free state.

Of the 36 that reached a cancer free state in the ISP group, they did so in an average of 8.36 months. Those in the chemotherapy group who actually reached the cancer free state, did so in 36 months. (6 patients)

INTRODUCTION

The primary intent of this study was to track I 00 patients with different types of cancer and compare lmmuStim to a control (placebo) group and a third group receiving standard chemotherapy for their type of cancer in accordance with ASCO.

PROTOCOL

ImmuStim ™ - CA/CAP Immunological Protocol

1. ImmuStim - CA: I - 2cc in a 3% to 5% multiple amino acid carrier. (Ex. Aminosyn)

2. ImmuStim Products: e lmmuStim Tablets- 1 tab three times daily.

3.

o ImmuStim Forte: lee IM one to three times weekly.

o ImmuStim - C: dose varies. o ImmuStim - W: dose varies. o ImmuStim - Plus: dose varies.

Other support as needed.

MATERIALS AND METHODS

PATIENTS

Patients were chosen from a patient pool including male and female with at least Stage II ( old classical staging) disease and varying ages.

STUDY DESIGN

The trial was multi-center with a primary center directing all activities. The duration of the study was 36 months with monthly examinations of:

(1) CBC (2) Tumor markers - arginine, alanine

and phenylalanine ( and others depending on the type of cancer)

(3) ROTS Pathology (Reactive Oxygen Toxic Species)

( 4) FRP's (Free Radical Pathogens) (5) NK Cells (Natural killer cells) ( 6) CT (Computed Tomography) (7) QLS (Quality of Life Survey) (8) Physical examination

There were three groups: ISP - ImmuStim Protocol C - Chemotherapy P - Placebo

Prior to any treatment of the study group, all patients were confirmed by pathological studies (Biopsy Report) as having active cancer cells in their body.

CLINICAL ASSESSMENTS/EFFICACY

The principal measures of efficacy were positive changes in tumor markers, tumor size and NK cells, morbidity and mortality with quality of life.

SAFETY

Laboratory (blood) studies were performed on a monthly basis. At each evaluation, within the physical and history, the physician reviewed and questioned the patient about his/her diary recordings of any "adverse" effects.

STATISTICAL METHODS

Any changes from baseline were calculated for all laboratory parameters and longevity. Changes were reported as averages for each group. The significance of the change was calculated using the paired t-test.

RESULTS

Over 1500 patients were screened and evaluated for pathological malignancy. For this study 100 patients were chosen.

Patients were from various countries however, a majority were Latin American. 58% were male and 42% were female. The mean age of the group was 41. 6 years o Id. ·

In the summary table and graph 50 patients were actually listed herein. However, 100 total patients were studied and the remaining results closely resembled the 50 reported here.

In our cancer data base there is more than 10,000 patients that have been treated with the protocol by various physicians and centers.

:tvfETS

STAGE

CBC (N=per ALS)

ARG (Arginine)

ALA (Alanine)

PI-IE (Phenylalanine)

NK (Natural Killer Cells) (N = 5 to15%)

ROTS (N = 0-10/15%)

FRP (0)

QLS

CT (Cat Scan) (Computerized Tomographic)

PE (Physical Exam)

WNL

LEGEND (ONCOLOGICAL)

Metastatic sites of malignancy

In the staging and grading of malignant disease normally the internatio~I staging system ofTMN is utilized(tumor size, metastatic progress, nodular involvement). For more simplistic comparisons the use of an older somewhat traditional system has been utilized even though all data for official records has been reported using TMN.

If any aspect was out of the normal range, they were recorded as Low (L ), High (H) or Within Normal Limits (WNL)

This is a key tumor marker that suppresses cancer growth.

This is a key tumor marker that suppresses cancer growth.

This is the key tumor marker that enhances or causes cancer growth to proceed at a more aggressive rate.

These are the key cells that act macrophagically to "kill" malignant cells.

Reactive Oxygen Toxic Species; a means of measuring the level of chronic degenerative disease.

Free Radical Pathogens; these have been shown to be radical electrons that are causal and part of chronic degenerative diseases such as Cancer and IDV/AIDS.

Quality of Life Survey;

If malignant areas are identified they are indicated by a(+). lfno tumors are present a(-). If the column shows a(+/-) this indicates that there is still malignant lesions but they are smaller and less aggressive.

During the patient examination, if they showed symptoms related to the disease they were classified as(+) otherwise(-).

Within Normal Limits

Cancer Group Sex Age Type Mets Stage CBC ARG ALA PHE NK ROTS FRP QLS CT PE ISP M 42 Prostate Bone IV L L L H 1% 85% 4 0-1 + +

Cancer free at 18 months. 0 WNL WNL WNL WNL 13% <10% 0 10

C M 45 Prostate Bone IV L L L H 2% 80% 4 I + + Died after 6 months. +

ISP M 69 Prostate Bone IV L L L H 0% 90% 4 1 + + Liver

No sign of active cancer growth. WNL WNL WNL WNL 10% 15% 1 10 +/- -

ISP M 21 Carcinoma IV L L L H 2% 90% 4 0 + + Stomach

Cancer free at 21 months. 0 WNL WNL WNL WNL 14% 5% 0 10

ISP F 34 Infiltrating Bone IV L L L H 1% 95% 4 0-1 + + Ductal cell Liver Carcinoma L. Breast

Cancer free at 35 months. 0 WNL WNL WNL WNL 15% 5% 0 10 +/- -

p M 49 Prostate Bone IV L L L H 1% 95% 4 0 + + Died after 3 months.

C F 64 Ademo- Liver IV L L L H 2% 85% 4 0 + + Carcinoma L. Breast

Died after 21 months.

ISP F 54 Ademo- Liver IV L L L H 1% 95% 4 0 + + Carcinoma Bone/Brain R. Breast


ISP M 45 Ademo- Liver IV L L L H 1% 90% 4 0 + + Carcinoma Bone

Colon I WNL WNL WNL WNL 12% 10% I 9 +/- -No cancer growth or activity.

ISP M 21 Melanoma Brain IV L L L H 2% 85% 3 1 + + I WNL WNL WNL WNL 10% 20% 1 9 +/- -

In 36 months the brain tumor has reduced from 5.2 cm to 0.6 cm.

C M 55 Ademo- Bone IV L L L H 1% 90% 4 I + + Carcinoma

Colon Died at 24 months.

Cancer ~

Group Sex Age Tnre Mets Stage CBC ARG ALA PHE NK ROTS FRP QLS CT PE ISP M 51 Oat Cell · Bone IV L L L H 1% 90% 4 0 + +

Carcinoma (Bilateral) I L WNL WNL WNL 8% 20% 1 8-9 +/- +

Patient is stable and returned to work. The cancer burden has decreased by 70%.

ISP F 31 Ademo- ? III/IV L L L H 1% 80% 4 1-2 + + carcinoma

both ovaries and uterus. 0 WNL WNL WNL WNL 13% 5% 0 10

Patient was cancer :free at 14 months.

C F 31 Ademo- Omentum III L L L H 2% 80% ~ 2-3 + + carcinoma R. Ovary

Lung IV L L L H 0% 98% 4 0 + + Patient is now under Hospice care.

ISP M 25 Hodgkins IV L L L H 2% 75% 3 3 + + Lymphoma

0 WNL WNL WNL WNL 15% 5% 0 10 Patient is cancer free at 11 months.

C M 27 Hodgkins IV L L L H 3% 80% 2-3 4 + + Lymphoma

n WNL L L H 5% 40% 1-2 6 + + Patient has improved but continues with the disease.

ISP F 11 Acute Lymphocytic IV L L L H 1% 98% 4 0 - + Leukemia

0 WNL WNL WML WNL 13% 5% 0 10 -Patient was cancer free at 8 months.

C F 13 Acute Lymphocytic IV L L L H 2% 95% 4 0 - + Leukemia

Patient died after 5 months.

ISP M 54 Ademocarcinoma III L L L H 2% 75% 3 2 + + Right lung

Patient was cancer free after 14 months. 0 WNL WNL WNL WNL 13% 5% 0 10 -ISP M 36 Astrocytoma ---- IV L L L H 2% 80% 3 1 + +

I/II L L WNL WNL 6% 25% 1 7 + + Th~~i~nt is stable w/out seizures and the lesion is decreasing in size.

ISP F 44 Thyroid Ill L L L H 2% 70% 3 3 + + Carcinoma 0 WNL WNL WNL WNL 14%

Patient was cancer :free at 22 months. 3% 0 10 -

Cancer Groue Sex Age Type Mets Stage CBC ARG ALA PHE NK ROTS FRP QLS CT PE ISP F 38 Infiltrating Liver, Bone IV L L L H 1% 98% 4 0 + +

Ductal Cell and Brain Carcinoma

Patient died after 11 months. She was improving during the first 6 months and then returned to smoking, heavy drinking and an unhealthy diet.

ISP F 32 Multiple Bone (6 sites) IV L L L H 2% 90% 4 3 + + I L WNL WNL WNL 9% 15% 1 9 +/- +/-

The patient is stable, working and the bone lesions are diminishing in size.

C F 38 Infiltrating Bone IV L L L H 2% 85% 4 1-2 + + Ductal Cell Carcinoma R. Breast

The patient died after 32 months.

p F 57 Ademo- Bone/Liver IV L L L H 1% 90% 4 1 + + carcinoma L. Breast

The patient died after 13 months. ISP M 65 Oat Cell IV L L L H 0% 98% 4 0 + +

Carcinoma (Bilateral) III L L L H 3% 80% 3 2-3 + +

The patient has improved but remains under intense care.

ISP M 26 Non Hodgkins IV L L L H 1% 85% 4 2 + + Lymphoma 0 WNL WNL WNL WNL 11% 10% 0 10

Patient was cancer free after 10 months.

C M 28 Non Hodgkins IV L L L H 1% 80% 4 2-3 + + Lymphoma II L L L H 5% 50% 2 6 + +

Patient continues with the disease but is improved.

ISP F 39 Ademo- Liver/Bone IV L L L H 2% 90% 4 1-2 + + Carcinoma Ovary I WNL WNL WNL WNL 8% 25% 1 8 +/- -

All lesions are diminishing in size.

C F 36 Ademo- Liver/Bone IV L L L H 3% 85% 4 2 + + Carcinoma Ovary


p F 37 Ademo- Liver/Bone IV L L L H 2% 85% 4 1 + + Carcinoma Ovary


Cancer Group Sex Age Type Mets Stage CBC ARG ALA PRE NK ROTS FRP QLS CT PE ISP F 51 Endometrial Omentum IV L L L H 1% 80% 4 2 + +

Carcinoma I L WNL L WNL 7% 25% 1 7 +/- -Patient is stable and the tumor burden has decreased 65-70%.

ISP M 71 Renal Cell III WNL L WNL H 4% 70% 3 3 + + Carcinoma R. Kidney 0 WNL WNL WNL WNL 14% 15% 0 9


ISP M 47 Ademo- Liver/Bone IV L L L H 1% 95% 4 1 + + Carcinoma of the colon 0 WNL WNL WNL WNL 13% 5% 0 10


C M 47 Ademo- Liver/Bone IV L L L H 2% 85% 4 1 + + Carcinoma of the colon


p M 45 Ademo- Liver/Bone IV L L L H 1% 90% 4 0-1 + + Carcinoma of the colon

Patient died after 8 ½ months.

ISP F 38 Inflamatory Liver/Bone IV L L L H 2% 90% 4 1 + + Carcinoma R. Breast 0 WNL WNL WNL WNL 15% 5% 0 10


ISP F 31 Inflamatory Liver IV L L L H 1% 95% 4 0 + + Carcinoma R. Breast 0 WNL WNL WNL WNL 13% 5% 0 9


C F 36 Inflamatory Liver IV L L L H 2% 90% 4 1 + + Carcinoma R. Breast


p F 37 Inflamatory Liver IV L L L H 1% 85% 4 0 + + Carcinoma R. Breast


Cancer Grou:e Sex Age Type Mets Stage CBC ARO ALA PHE NK ROTS·FRP QLS CT PE ISP M 56 Oatcell IV L L L H 0 95% 4 0 + +

Carcinoma (Bilateral) I L WNL WNLWNL 15% 10% 1 9 +/- -

Patient is living but very deteriorated.

ISP M 51 Ademo- Liver/Bone IV L L L H 1% 95% 4 0 + + carcinoma of the colon 0 WNL WNL WNL WNL 11% 10% 0 10 +/- -

Patient was cancer free after 31 months with bone and liver lesions decreasing in size.

ISP M 69 Renal Cell IV L L L H 2% 95% 4 1 + + Carcinoma (Bilateral)


ISP M 61 Carcinoma Bone IV L L L H 1% 75% 4 0 + + of Prostrate I L WNLWNL WNL 6% 20% 1 8 +/- -

Patient is stable, improving and able to work.

ISP M 26 Hodgkins III L L L H 2% 90% 4 2 + + Lymphoma 0 WNL WNL WNL WNL 14% 5% 0 10


C M 28 Hodgkins III L L L H 2% 85% 4 1-2 + + Lymphoma 0 L L WNL WNL 6% 15% 1 8


ISP M 52 Glioblactorna Bone IV L L L H 1% 95% 4 0 + + Brain 0 WNL WNL WNL WNL 13% 5% 0 9-10 -

Patient was cancer free at 32 months. He had surgical resection with ImmuStim used to flush site and then the protocol was used.

ISP M 56 Carcinoma Liver IV L L L H 0% 98% 4 0 + + of Pancreas 0 WNL WNL WNL WNL 13% 10% 0 10

Patient died after 36 months from a myocardial infarction.

ISP M 54 Carcinoma IV L L L H 1% 90% 4 0 + + of Pancreas L WNL WNL WNL 12% 8% 0 9 +/- -

Patient is stable, working and without signs of the disease.

VIIl. THE FUTURE OF CANCER

At the current rate of cancer growth more than 30% of the worldwide population will be affected in a short matter of time. Further, the results of chemotherapy and radiation therapy are growing

less effective because cancers are becoming more aggressive. We believe that with the recent adjustments made in the protocol, we are very close to conquering this disease. The average cancer free state with ISP has gone from 81 % to .the current level of 93. 7% in all patients.

IX. AFTERTHOUGHTS

With the amended protocol we have realized that both the treatment of oncological disease and chronic degenerative disease is no longer the primary issue. As. has always been the case, timing and the progression of the illness is by far most critical. Once one has experienced immunological damage, which leads to nutritional damage or in the reverse manner, it then becomes extremely difficult to repair the state.

Thus, the task at hand in accordance with our most recent data is not so much the treatment of the malignancy but the continued treatment of the overall nutritional state.

It is our contention that from the inception of treatment, one should nutritionally support treatment with proper diet, vitamins, and supplement the overall nutritional status of the diseased patient.

DISCUSSION

It is evident that Immunotherapy not only is the treatment of choice for cancer patients, but wherein may exist the cure for cancer. In synopsis, lmmuStim-CA/CAP lmmuno logical Protocol has proven to be considerably more efficacious than chemotherapy and other treatment modalities.

It can be said that ISP provides:

1. Improved quality of life in I 00% of patients. 2. Increases longevity. 3. Conservatively, provides a greater cancer

free state-36% higher than chemotherapy. 4. Provides a greater remission rate - 55.2%

higher than chemotherapy. 5. Has a much lower death rate than

chemotherapy - 8.4% (ISP) verses 63.6% with chemotherapy.

6. If there is any at all, ISP has a much lower toxicity rate when compared to chemotherapy.

TABLE#2

PROTOCOL SUMMARY

PROTOCOL Ave.# % Cancer Ave.# Partial Ave.# # of Patients Months Free Months Remission Months Deceased

lmmuStim/CAP 60 36 60% 17 28.3% 7 11.7% Immunological Protocol

Chemotherapy 25 6 24% 6 24.0% 13 52.0%

Placebo 15 1 6.7% 6 40.0% 8 53.3%

GRAPH#l

(100 Patients - Mixed Cancer)

p

E R C E T A G E

CANCER FREE STATE

75

50

_______ ImmuStim - 60% -----7 36%

25 Chemotherapy - 24% .J·

Placebo - 6. 7%

0

PARTIAL REMISSION

ImmuStim - 28.3%

Chemotherapy - 24%

OVERALL DIFFERENCE (Improvement)

CR/PR* ImmuStim = 88.3%

40. 3 % Better response with ImmuStim

Chemotherapy = 48.0%

CR = Complete remission / cancer free. PR= Partial remission.

% of Deaths 11.7%

52.0%

40.3% Greater Death rate with Chemotherapy

The general difference when comparing 500 ImmuStim patients (mixed cancers) with 500 patients receiving standard chemotherapy shows:

ImmuStim

Chemotherapy 55.2% Better

CR/PR

92.6% J-37.4% with ImmuStim

55.2% Greater death rate

% of Deaths

8.4%)-

63.6% with Chemotherapy

SUMMARY OF CANCER TREATMENT USING

IMMUSTIM™ - CA/ CAP IMMUNOLOGICAL PROTOCOL

Now that you have bad the opportunity to read and study about ISP and its effects on cancer, you probably have opinions / questions regarding the following points:

I.

I. II.

III .

How it Works / Efficacy Comparison to other therapies including Chemotherapy and Radiation Patient compliance and cost

HOW IT WORKS I EFFICACY

ISP is an immunolog ical treatment - a treatment of your defense systems . ISP does the following:

A. FUNCTION 1. Directly and indirectly builds ones

immune system to better fight cancer. 2. Kills cancer cells . 3. Improves the quality of life in all

patients that are treated. 4. Has little or no toxicity when compared

to chemotherapy .

B. PROVEN EFFECTS 1. ISP, when compared to other cancer

treatments, is generally 51 % more effective. It is more than 93. 7% effective in obtaining patient remission and/or a cancer-free life.

2. When compared to chemotherapy, Radiation, etc., the ISP is far superior and doesn't have the negative side effects.

FIVE YEAR A VERA GE SURVIVAL RA TES 100%

86% ImmuStim - CA I CAP Protocol

75%

50%

35% Cbemothera - Radiation - Misc.

25%

5 Years

II. COMPARISON

With ISP, 100% of the patients reported a marked improvement in their quality of life. Improved energy. no nausea. no hair loss and no weight loss were a few of the patient observations. Taking a treatment that kills cancer cells while causing one to teel better is what ISP is all about.

III. PATIENT COMPLIANCE AND COST

Many cancer patients are hospitalized while taking chemotherapy and/or radiation and are on many medicines that do nothing toward the killing of cancer cells. Some of which are:

I. Pain medicine 2. Anti-nausea medicine 3. Medicine to protect the stomach from

the other medicines 4. Laxatives 5. Hormones (if needed) 6. Anti-anxiety pills 7. Sleeping pills

In contrast, everything about ISP goes toward strengthening a patient's defense and kill the cancer. The program is relatively simple and effective.

COST PER YEAR COMPARISON

I. 2. 3.

Chemotherapy Radiation ISP

$175,000 USD (min.) $ 75,000 USD (min.) $ 45,000 USD **

* * This does not include travel, hotel accommodations, etc. and is based on normal ambulatory treatment. One can figure from $50 -$100 USD per day for room and board. Airfare from Miami, Florida is approximately $300 USD.

------- ---- -- '.

REFERENCES

c. Caplinger, G.E., "'lmmuno-Therapy As Primary Therapy'\ BWI Press, May 1990

e Caplinger, G.E.. "The Utilization of Amino Acids in the Treatment of Chronic Degenerative Disease'". (Manual) 1988

• Caplinger, G.E.. ""Effects of Biological, Biological Response Modifiers and .Nutritional Supplementa-tion in Patients with Various Types of Cancer in Attempt to Reactivate the Complete Immune Response." 1990

G) Beahrs, O.H., etal. Manual for Staging of Cancer, 3rd edition. Philadelphia: J.B. Lippincott Co. 1988

o Casciato, D.A., and Lowitz, B. Manual of Clinical Oncology, 2nd edition. Boston: Little, Brown & Co., 1988

• DeVita V., etal. Cancer Principals and Practice of Oncology, 3rd edition Philadelphia: J.B. Lippincott Co., 1989

DISCLAIMER

All information and treatment originated m and from The Dominican Republic.


CDO's, Cancer and HIV/ AIDS vary from person to person and so does the results. No results are, or should be considered typical _or expected. As with all medicines and protocols, the results will vary from patient to patient.

ADVANCES In

HIV/AIDS

Treatment and

Management

ImmuSti,n-V/CAP Immunological Protocol™ P oves Efficacious in HIV/ AIDS Therapy

••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••

PROGRESS CONTINUES - UPDATE 1998

PRIMARY IMMUNOTHERAPY / HIV/AIDS PATIENTS TURN VIRAL NEGATIVE

As you will note, the mv study included the modified protocol which considers cofactors that enhance CDD, cancer and IDV/AIDS.

The added components consist of (1) antihelmitics, (2) antiamoebics and (3) antifungals. We firmly believe these are critical in reaching a viral free state. In fact, a year ago in Lancet and the NEJM it was reported that many persons with CD4 levels of zero do much better if they are fungal free (candida). Maybe this is the same with amoebae and parasites.

NOTE TO THE READER

While you may note an extremely high level of viral negative patients we are not proclaiming ISP as a cure -for this disease. However, it is our firm conviction that ISP is the best option as far as we know and we are continuing to enhance the protocol.

ABOUT THE AUTHOR

Gregory E. Caplinger, MD, DS9., FACIP, FIAM.

BIOGRAPHICAL SKETCH

Dr. Gregory E. Caplinger is both a scientist and clinical physician. It has been Dr. Caplinger's goal and experience through the years to combine the pure scientific research with practical clinical application.

He is a European (British) and U.S. trained physician with his medical residency in Internal Medicine and further · sub-specialties of clinical oncology/immunology. He currently continues his post-graduate medical education both in Europe and the United States, where he regularly attends courses at Harvard Medical School, Division of Continuing Education. His board certifications include Internal Medicine/Clinical Oncology.


He has published over 26 articles as primary author and written a Laboratory manual entitled "Practical and Clinical Immunology for the Classroom." He recently completed a textbook titled "Progressive lmmuno logy" (Released in 1996).

His past and present accomplishments are noted and include the "Caribbean International Prize in Medicine" ( international prize given to research scientists that have contributed vital information in the area of Medicine. He is also a member of many scientific/medical organizations where he has also held positions of leadership. Further, Dr. Caplinger has recently (1995-1996) been named as an entry to the national publication: International Who's Who of Contemporary Achievement, recognized for Excellence in Medicine and Science. Dr. Caplinger is also very active in teaching and lecturing worldwide.


In March 1994, Dr. Caplinger and his research team released the results of a new biological medication, "ImmuStim"™, for the treatment of IDV/AIDS and Cancer. This data was published in June of 1995 in the peer review journal, "Salud lntregral".

I. II.

III. IV. V. VI.

VII. VIII.

IX. X. XI.

XII.

HIV: What is this horrible plague? Initial Infection: Enhanced via infectious cofactors. The Cause of AIDS AZT-The Silent Killer Mixed Therapies (MT): Do They Work? Common Factors in Patients with Zero Viral Loads Immunosuppression HIV is a Virus: AIDS is a Condition - The Treatment Plan. Summary Data Conclusion Research Article: ImmuStim-V /CAP Immunological Proto~ol as Primary Therapy in HIV/ AIDS - Cure or Remission. (Summary) Afterthoughts

I: HIV: WHAT IS THIS HORRIBLE PLAGUE?

While there has never been any real doubt about the specifics, (1) IDV is a virus (2) It affects the immune system, (3) retrovirus, etc., there still remains much controversy as to HIV's origin, the real cause and thus, an effective plan of therapy.

Since its detection IIlV has produced or better yet, caused many specialists and scientists to develop a system or staging pattern to better define the virus. While newer parameters have been written, this author feels the staging developed by the WalterReed Hospital in 1986 is still best in general terms. The classification is as follows:

STAGES OF HIV-I DISEASE PROGRESSION

In HIV-disease, the specific symptoms, their patterns and their timing of onset can vary so greatly that some sort of scheme for recognizing various stages of seriousness of the disease is necessary for putting therapeutic strategies to use. Thus, starting in 1986, the Walter-Reed Hospital developed the following "Staging Classification":

Stage 0: A negative blood test ( seronegative) for Hiv-1; a normal T4-helper cell count (over 500).

Stage I: IIlV-1 infection ( seropositive) revealed by the detection of HIV-I nucleic acids or proteins or of specific antibodies to IIlV-1 in the blood.

Stage 3,4: Overlaps with ARC (AIDS-Related Complex). Subtle but progressive immune system dysfunction judged by a decline in delayed hypersensitivity in skin testing; the appearance of the first opportunistic infections. (Delayed-type hyper-sensitivity testing, or DTH, is a simple but reliable skin test for assessing the overall competence of the subject's immune system)

Stage 5,6: Clinical AIDS, Multiple clinical symptoms of a deficient immune system; a marked weight loss (the ''wasting" syndrome); a continued downward trend in the T4-helper cell count; rampant opportunistic infections.

SeroConversion

As one can suspect and question, what is or can we predict the time of seroconversion after infection. At this junction many factors come into play including not only the viral load and multiplication, but also the actual status of the recipient's immune system at the time of viral contact. Further, if one is infected or is subject to an "injection" of the virus, is there a seroconversion 100% of the time? In remaining true to this author's philosophy and actual patient observations - No. If the recipient's immune system is sufficient, there is much evidence to support the fact that many people never convert.

l.eji: An antibody molcmh:, showing the variable antigen-binding ~ites. Ritlzt: A bow, gp 120 of H l \'-1 binds to the CD4 m:cptor on a host cdl. Below antibodit.-s against HJ V-1 block its gp 120 binding sites. (From Pock,:t Picture Guides: AIDS, by I. \Villiams and others. (;ower Medical Publishing, New York.)

ORIGIN OF HIV-1

Since the early 80's, there has been much speculation as to the origin of HIV-1. We have heard everything from "the monkey story" to "biological warfare". From all of this two substantial articles have emerged. The first article was that of Smith, et al. in Nature (Vol. 333; pp. 573-575, 1988) who traced the RNA genetic print back to the ancestor of IIlV-1 to at least 40 years up to a maximum of80 years old.

Second, Gallo and Temin concluded in Scientific American (Vol. 259; pp. 41-48, 1988), that IDV-1 has infected humans for more than 20 but less than 100 years. As one examines the scientific record further, it becomes evident that HIV-1 could have been either an accidental or intentional product of

tne laboratory. As noted by many virologists, the probability of HIV-1 having arrived as a result of "natural selection" is very weak at best. Thus, as scientists, it does behoove us to continue to search for clues until this viral question has been equivocally answered.

In conclusion and without hesitation , one can readily see that HIV /HIV -1 is a virus out of contro I and one that must be stopped.

II. INITIAL INFECTION: ENHANCEMENT VIA INFECTIOUS COFACTORS

In this section we will consider the parameters surrounding the infection process and subsequent seroconvers1on.

Lefi: l hc anatomy of HIV - I and the k9· L'tHlStituents nf the viru~ pdrticle ( horn ,\Jnv Scim1i.s1. 27 ~brch I 987.) Ri~hr. (J1ole5tt~rol. ph L\•;pholipids make up thl.' \1fUS envelope .

?,-,.,tn / C \o / ~P2•

'R"v'-'rc,, tronv. 11pt..iri~ ~l'IZ!MA

As previously noted, there are persons who have been subjected to HIV and who years later, are negative. Also, there are people that are HIV positive and never develop AIDS. Since these conditions exist , there must be answers. These answers may be our clues to a cure and/or effective therapy.

To this author , scientist and clinician, there is little doubt after treating and/or studying in excess of I, 000 HIV/ AIDS patients, that infectious cofactors

not only enhance HIV-1 activity, but also are a part of the seroconversion and are vital in the treatment and cure.

This data has been observed and recorded in multiple patients , not only by our staff, but also by others. We have observed two categories of affect which are (1) enhancement/acceleration and (2) causal / therapeutic.

In the area of acceleration, one key factor among the long-term survivors is the absence of past effective treatment for human herpes virus 6 (HHV -6). It has been reported by Gallo, et al. that HHV-6 enhances HIV-1 replication. This would support why many persons with low CD4 cell counts and without HHV-

. 6 are doing quite well after 14 years of in{ection. Also noted is the work of Lo and Shi who contend that a mycoplasma organism plays a significant role in AIDS/HIV - 1 disease. The mycoplasma (parasiteparasitic bacteria) may be a factor or the key factor at the beginning of a viral infection that may trigger the evolution of HIV infection to a point of immune system inhibition (Montagnier; JAMA Dec. 26, 1990; p. 3112). Other key cofactors no doubt are the herpes viral family, herpes simplex I, II and herpes varicella-zoster.

In the area of causal, it is our observation and contention that without a given set of parameters, one or both of the following cannot occur: (A) seroconversion and, (B) progression of the viral infection to the full blown condition of AIDS.

As one will see in a subsequent section how successful therapy must address not only destruction of the virus and opportunistic infections, but also the cofactors.

III. THE CAUSE OF AIDS

For quite some time there has existed a controversy as to HIV-1 being the sole cause of AIDS. Data seems clear in at least indicating that HIV-1 is one of the initiators of AIDS, however, it may not be the only initiator.

As seen in the earlier diagram, the anatomy of HIV-1 is that of a virus and, more specifically, a retrovirus. As a virus, it cannot grow and reproduce on its own. But, HIV-1 is a persistent virus. Once it

enters a host cell. it becomes a permanent part of the life of the cell. Along with other factors, it is highly probably that this virus is part of, or may produce , the condition AIDS.

It is our contention, supported by evidence , that the condition of AIDS is first noted by initial infection from a virus such as HIV- 1 and or a similar strain of HIV. Depending on one·s immuno logical status, various posibve or negat ive events may occur .

Secondly, cofactors either enhance/accelerate or poss ibly cause a lack of seroconversion.

COFACTORS

MIXED COFACTORS

A. Infectious agents B. Prescr iption drug use, (i.e. Cort icosteroids,

ant ibiotics) C. Street drug use, (i.e. Cocaine, marijuana) D. Psychological stress E. Nutr itional status

BIOLOGICAL COFACTORS

A. Hepatitis B virus (HBV) B. Human B-Lym photropic virus (HBL V) C. Mycoplasma -paras itic D. Different HIV strains

Thus, at any given time from contact to condition, cofactors can be derailed and successfully treated.

HIV Contact

A. B. C. D. E. F.

KEY FACTORS

Cofactors Steroid Heavy AJcohol Present Parasites Use HBV Use

Mycoplasma Divorce Antibiotics

I Loss of Job

Contact with HIV Suppressed immune function Cofactors present (multiple) Further immune suppression Poor nutritional status Opportunistic infect ion( s)

It is our conviction that in order for a person to proceed lo full blown AIDS and subsequent death, one must have all of the key factors (A-F) present and active.

lV. AZT - THE SILENT KILLER

While we are not extremists by any means, it has always been evident to ow- staff that AZT in most, if not all cases, has little positive effects and actually is mOTe damaging than beneficial.

The following informat ion is taken from medical authorities and/or medical textbooks on AZT:

Peter H. Duesberg , PHD , a professor of molecular and cell biology at the University of California, was elected to the National Academy of Sciences in 1986 because of his work with Retroviruses and received a seven-year outstanding investigator grant from the Nationa l Institutes of Health to investigate the virusAIDS hypothesis. Duesberg proposed that various diseases are brought on by the long term consumption of recreationa l drugs and AZT, (which is prescribed to prevent or to treat AIDS) which he thoroughly discusses in his book, THE GOOD NEWS IS HIV DOESN 'T CAUSE IT - AIDS -THE BAD NEWS IS "RECREATIONAL DRUGS" AND :MEDICAL TREAT:MENTS LIKE AZT DO, Health Action Press, 1995. On page 104 of his book, Dues berg reprints the fo Bowing label:

2511 A-2169 LttJlH7U& li:lla~·i.;.;it·_:~i.·_·.,~:.. :E-, r : ··i '! rp· . .. . . . ~ -,.~~ .. !;$ ~~ ..... . J.il ,.

TOIM: . . 3'-AZID0-3'· xv. ~"ffi:H i. THYMIDINE ~ l!:.11::~. (AZT; Azidothymldtn1) /DIUMJ

:k !~l~J~~ ! Desimte k"'4~ OtPl~ M7J !tllol Hit llbtl 111111 Storeat less ,., ....., • .., . ._ • pe1sllll. Wur 111bbl th1" Q•C t'II. ..._.,.,. orolldln cloltq. · ,.,_,

As Duesberg points out, this label is for a 25· milligram dose of AZT, yet anyone who has HIV I AIDS receives a daily dose of 500 milligrams.

To show why AZT is so toxic, the following facts are taken from THE MERCK INDEX, AN ENCYCLOPEDIA OF CHEMICALS, DRUGS

AND BIOLOGICALS, published by Merck & Co., Inc., 1989:

10223. ZIDOVUDINE. 3' -AZIDO-3' - DEOXYTHYMIDINE; AZIDO-THYMIDINE; AZT; BW A509U; RETROVIR.

9333. THYMIDINE. I' - (2-DEOXY-B-DRIBOFURANOSYL)-5- METHYLURACIL

6051. 6-METHYLURACIL. 6-METHYL-2,4 (lH, 3H) - PYRIMIDINEDIONE; SYNTHESIS FROM UREA AND DIKETENE.

5177. KETENE. ETHENONE; CARBO-METHENE. HUMAN TOXICITY: POISONOUS GAS OF THE SAME ORDER OF TOXICITY AS PHOSGENE.

7310. PHOSGENE. CARBONIC DICHLORIDE. HUMAN TOXICITY: INSIDIOUS POISON AS IT IS NOT IRRITATING IMMEDIATELY, EVEN WHEN FATAL CONCENTRATIONS ARE INHALED. MAY CAUSE SEVERE PULMONARY EDEMA (MAY BE QUICKLY FATAL) OR PNEUMONIA.

You will note that Phosgene causes Pneumonia, which is the primary cause of death in AIDS patients. What is most disturbing is that all medical students are taught in medical school to follow the Hippocratic oath which states in part, "I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice. I will neither give a deadly drug to anybody if asked for it, nor will I make a suggestion to this effect ... I will not use the knife (surgery) ... ," OWSEI TEivlKIN & C. LILIAN TEMKIN, EDS., "THE IIlPPOCRATIC OATH/' ANCIENT MEDICINE: SELECTED PAPERS OF LUDWIG EDELSTEIN (BALTIMORE: JOHNS HOPKINS PRESS, 1967), 6. The Father of Western Medicine, Hippocrates (Born 460 B.C.), also stated, "Let food be thy medicine and medicine thy food." How then can any medical doctor loyally, morally, or ethically prescribe a poison like AZT to any of his patients? Even the medical school textbook "HAZARDS OF MEDICATION, J.B. Lippincott, 1988, states "THERE ARE NO HARMLESS MEDICATIONS," and "EVERY MEDICATION IS POTENTIALLY HAZARDOUS."

The other farce is that modem medicine still fo Hows the teachin~s of Louis Pasteur, who stated in 1878

that all diseases "were caused by germs. However, Professor Claude Bernard (1813- 78), disagreed with Pasteur and contended that no matter where germs came from, they presented a danger only if the body was in a run-down state due to a "milieu interior", which in French means the "Environment within". Even as he was dying, Pasteur stated, "Bernard was right; the germ is nothing-the milieu is everything". Duesberg also shows that an HIV virus is not the cause of AIDS. An article by Dr. Gerald L. Getson of Princeton titled "The Private Science of Louis Pasteur", April 1995, was printed in the NEW YORK TIMES on May 16, 1995 and stated, "Louis Pasteur, one of the legendary figures in the history of science, lied about his research and was deceitful in ways that would now be regarded as scientific misconduct if not fraud".

V. MIXED THERAPIES (MT) DO THEY WORK?

A few years ago the therapies using AZT, OTC, etc. and protease inhibitors were producing seemingly good results. Patient's CD4 levels were rising and viral loads were decreasing - then suddenly it stopped.

This author and others believe that it is because of sensitization and thus further mutation of the virus that has caused this lack of positive response.

Most common therapies direct their efforts at

specific antiviral aspects of IIlV instead of stimulating the patient's general / specific immune system along with anti-viral therapy. ISP does just that.

Therefore, we anticipate the use of ImmuStim- V and subsequent protocol will accomplish the following:

1. Killing of the mv and any or all of the causative agents.

2. Elimination of the metabolic wastes via the oxidation of any existing free radical pathogens (FRP's) with the use of oxidants.

3. Immunological stimulation in general with the stimulation of T Cells, macrophages, CD4 cells via the utilization of nonspecific immune stimulants.

4. Reparation of damaged and destroyed cells with the use of DNA/RNA modifying substances.

5.

6.

General nutritional support with the use of parenteral (IV) amino acids as the carrier for ImmuStim-V. Complete 100% improvement in the quality of life of those infected.

MATERIALS AND METHODS

PATIENTS

Patients were randomly selected for follow-up from a pool of those previously evaluated. Their age, sex and degree of disease varied.

All patients had been confirmed HIV positive via Elisa Western Blot, P24 antigen, CD4/CD8 with opportunistic infections or lack thereof Further, all patients under the direction of an Institutional Review Board (IRB) gave informed written consent prior to entry to the trial. This was done in accordance with the Declaration of Helsinki (1989).

STUDY DESIGN

The follow-up was completed under the direction of a Dominican Republic medical center. The duration was 36 months. Evaluations were completed monthly for the entire study. They consisted of (A) CBC, (B) Differential with platelets, (C) CD4+ cell count, (D) NK cell count, (E) CIC levels, (F) P24 antigen and, ( G) physical examination and (H) lymphatic biopsies.

Prior to entry and upon completion of the 36-month study, patients were evaluated as to their seropositive or negative status.

CLINICAL ASSESSMENTS / EFFICACY

The principal measure of efficacy was positive changes in CD4+ levels and P24 antigen levels and lymphatic biopsies and to a lesser degree but equally important, morbidity and mortality with quality of life.

SAFETY

As previously stated, laboratory (blood) studies were performed on a monthly basis. At each evaluation, within the physical and history, the physician reviewed and questioned the patient about his/her diary notes referring to any "adverse" effects.

STATISTICAL METHODS

Any changes from baseline were calculated for all CD4+, CDS, NK, P24 antigen along with longevity was reported as averages for each group. The significance of the change was calculated using the paired t-test.

RESULTS

One hundred patients were randomly selected from those already in the program (with 50 patients summarized). These varied in sex, age, and level of disease. All were seropositive for HIV. Most patients were of Latin descent with some Americans included.

VI. COMMON FACTORS IN PATIENTS WITH ZERO VIRAL LOADS

We have diligently searched for commonalties in all treatments including ISP. We found that all patients had the following in common:

1. 2. 3. 4. 5. 6. 7. 8. 9.

Stimulating immune program. Good dietary habit - low/no meat in diet. No use of tobacco. Little/no use of alcohol. Regular exercise program. Stress reduction program. Strong spiritual convictions. Strong will to live. Good support system - surrounded by positive people.

There is no miracle pill for the common cold so we cannot expect one for HIV/AIDS. As with any major event in life there comes preparation before the event. In this case, it is literally a fight for life.

VII. IMMUNOSUPPRERSSION

While we continue to spend billions of dollars and years of research oµ AIDS, one point becomes extremely clear: with no immunological suppression one will not proceed to AIDS. Therefore, two key factors must become evident: immunological status prior to infection and restoration of immunological status after infection.

Multiple authors, including Caplinger, have noted in studies that ( 100%) all persons are immunosuppressive before HIV seroconversion.

In HIV positive persons, Candida infects over 50% and its involvement is close to 100% in AIDS/ ARC cases.

The key components to immune suppression are:

o Destructive habits ( drug use, smoking, excessive alcohol us).

o Emotional/Psychological Status (not properly dealing with stress - excess stress).

o Destructive, excessive prescriptive drug use ( coricosteroids, antibiotics).

o Environmental Stress ( chemical contamination). • Nutritional status (type of diet). o Physical status (level of exercise). o Past Immune Diseases (allergies, herpes, EBV)

These are but a few of the important factors in maintaining and/or restoring our immunological status and function. Any effective treatment must not only "kill the virus" but also restore immune function.

VIII. HIV IS A VIRUS: AIDS IS A CONDITION THE TREATMENT PLAN

While many continue to debate the nature of Human Immunodeficiency Virus (IDV) one item stands clear: mv is a virus with AIDS being one of or the conditions produced by an immune system that is no longer functioning properly. One must, if to be successful, accomplish two major tasks: kill the virus and/or causal factor(s) and, repair and rebuild the immune system.

These two components must be a part of any successful long-term program and/or pharmaceutical approach to IDV / AIDS.

In the protocol utilized by Caplinger et ai it is just that. It is a protocol that effectively kills the virus and cofactors while repairing/rebuilding immunological integrity and function. It is very much our conviction that the biological cofactors play a vital role in the development of AIDS. Our protocol and biological medicine aggressively addresses immunological integrity and function.

IX. SUMMARY DATA OF 100 PATIENTS (50 Reported)

The legend for the following tables of Summary Data is as follows:

ISP

MT

p

ROTS (N = 0-10/15%)

FRP (N=0)

CD4 Cells (N = 1000)

P24 Antigen (N=0-5mg/dl) (Positive is 6 To 20 mg/di)

Lymphatic Biopsy (N =Negative)

Viral Load (N= <400 CPM) (CPML)

Quality of Life Survey (QLS)

ImmuStim Protocol

Mixed Therapies

Placebo

Reactive Oxygen Toxic Species; a means of measuring the level of chronic degenerative disease.

Free Radical Pathogens; which have shown to be radical electrons that are causal and part of Chronic Degenerative Diseases such as Cancer and lilV/AIDS.

These are part of the WBC's that are directly affected by IDV. (1,000 CD4 Cells is considered a healthy immune system.) Above 500 is not considered to be AIDS.

This is the protein antigen associated with HIV.

. Fine needle biopsies were done in both axillary and inguinal lymph glands and examined for HIV. The order is R to L axillary and then R to L inguinal.

The Viral Load is measured via·PCR with a range of 400 750,000 CP:ML.

This is a series of subjective questions to the patient on how they feel and if they are able to function normally.

--- - - ---

WESTERN LYMPHATIC VIRAL GROUP SEX AGE ELISA BLOT ROTS FRP CD4 P24 BIOPSY LOAD QLS

ISP M 25 + + 95% 4 .so +19 +/+/+/+ 0 0 + + 15% 0 950 - 1 - I-/-/ - 10

Patient was viral free after 18 months.

ISP M 29 + + 90% 4 100 +20 +/+/ -/ - 0 1-2 + + 10%, 0 800 -0 - I -I-/ - 9


MT M 24 + + 90% 4 75 +18 +/+/+/+ 520,000 1 + + 45% 3 310 +15 +/+/+/+ 5

p F 33 + + 85% 4 125 +16 +/+/+/+ 0-1 Patient died after 25 months.

ISP F 46 + + 90% 4 20 +20 +/+/+/+ 450,000 0 + + 25% 1 550 +7 - I-/+/+ 7

Patient is stable and has returned to wotk.

ISP F 27 + + 90% 4 25 +20 +/+/+/+ .o 0 + + 15% 0 875 - 1 - I-/-/ - 10

Patient was viral free at 10 months.

MT F 36 + + 70% 3 100 +17 +/+/+/+ 0-1 Patient died after 11 months.

MT M 51 + + 85% 4 50 +20 +I+! -I+ 355,000 1-2 + + 50% 3 125 +15 +/-I-/ - 4

ISP M 19 + + 95% 4 10 +20 +/+/+/+ 750 0 + + 25% 1-2 250 +9 +/+/+/+ 6-7

Patient is stable, working and continuing to show signs of improvement.

p F 22 + + 95% 4 50 +17 +/+/+/+ 0 Patient died after 9 months.

ISP M 31 + + 90% 4 15 +20 +/+/+/+ 220 1 + + 15% 1 650 -5 +/+/+/+ 8

Patient is currently living a normal life.

MT M 25 + + 95% 4 70 +19 +/+/+/+ 1255 1 + + 30% 1-2 650 +7 +/+/+/+ 6-7

ISP F 36 + + 80% 4 40 +20 +/+/+/+ 25 0-1 + + 10% 0 825 -2 - I-/ -I - 10



MT M 29 + + 90% 4 10 +20 +!+/+/+ 0 Patient died the last month of the study.

p F 39 + + 85% 4 100 +18 +!+!+/+ 0-1 Patient died after 5 months.

ISP F 34 + + 95% 4 20 +20 +/+/+!+ 0 + + 10% 0 820 -2 -1-1-/ - 0 10

Patient is viral free after 14 months.

ISP F 19 + + 95% 4 10 +20 +/+/+/+ 0 + + 5% 0 1100 -0 - I-/-! - 80 10


MT M 61 + + 80% 4 120 +18 +/-/-I - 2 Patient died after 29 months.

p M 23 + + 90% 4 100 +16 +/+/+/+ 3 Patient died at the end of this study.

ISP M 39 + + 95% 4 so +20 +/+/+/+ 0 0-1 + + 5% 0 950 -0 - I -I -I - 10


ISP F 31 + + 75% 3 120 +15 - I -/+I - 0 4 + + 5% 0 1200 -0 - I -I -I - 10


ISP F 18 + + 85% 4 100 +18 +/+/+/+ 150 1 + + 30% 1-2 500 +7 +!+/ -I - 7

Patient improved and returned to work.

MT M 27 + + 900/o 4 120 +19 +/+/+/+ 170,000 1 + + 40% 2 250 +15 +/+/+/+ 5

MT M 29 + + 95% 4 70 +20 +/+/+/+ 0 Patient died after 20 months.

ISP F 31 + + 75% 3 120 +15 - I -!+I - 0 4 + + 5% 0 1200 -0 - /-I-/ - 10

Patient was viral :free after 7 months.

ISP F 18 + + 85% 4 100 +18 +/+!+/+/ 620 1 + + 30% 1-2 500 +7 - +/+/ -:I- 7

Patient improved and returned to work.

MT M 27 + + 90% 4 120 +19 +/+/+/+ 1450 1 + + 40% 2 250 +15 +/+/+/+ 5

WESTERN LYMPHATIC VIRAL GROUP ·SEX AGE ELISA BLOT ROTS FRP CD4 P24 BIOPSY LOAD QLS

MT M 29 + + 95% 4 70 +20 +/+/+/+ 0 Patient died after 20 months.

ISP M 29 + + 95% 4 10 +20 +/+/+/+ 0 0 + + 5% 0 1115 -0 - I -I -I - 10


ISP M 21 + + 90% 4 20 +20 +/+/+/+ 0 0 + + 10% 0 950 NEG - I -I-/ - 10


MT M 23 + + 90% 4 55 +18 +/+/+/+ 0 1 + + 5% 0 875 -1 - I-/-/ - 10


MT M 21 + + 95% 4 120 +16 +I-/-/ - 2 Patient died after 14 months.

p F 23 + + 90% 4 50 +17 +/+/+/+ 1 Patient died after 9 months.

ISP M 56 + + 95% 4 20 +18 +/+/+/+ 0 0 + + 10% 0 755 NEG -1-1-/ - 10


MT M 23 + + 80% 3 150 +10 - I -I-/ - 3-4 Patient died in 14 months.

p F 26 + + 90% 4 100 +18 +/+/+/+ 0-1 Patient died after 20 months.

ISP M 29 + + 95% 4 15 +20 +/+/+/+ 10 o· + + 5% 0 800 -0 - I -I-/ - 10


MT M 31 + + 90% 4 40 +20 +I -I-/+ 0 I + + 10% 1 780 NEG - I-/-/ - 8-9


p M 53 + + 95% 4 100 +16 - I-/+/+ 2-3 Patient died after 34 months.

ISP F 64 + + 85% 4 110 +17 +/+/+/+ 1 Patient died after 9 months.

ISP F 23 + + 75% 4 60 +20 +/+/+/+ 0 1-2 + + 5% 0 1250 NEG -1-1-1- 10



MT M 29 + + 65% 3 325 +12 - I -I -I - 5 Patient died after 4 months.

MT F 38 + + 70% 4 190 +15 - I-/+/+ 200,000 4-5 + + 50% 2 250 +12 - I-/+/+ 6-7

Patient is stable.

p M 16 + + 95% 4 20 +11 - I-/-/ - 115,000 2-3 + + 65% 2 150 +11 -I-!+/+ 4

Patient is stable.

p F 19 + + 85% 4 200 +12 +/+/+/+ 0 2 Patient died after 36 months.

MT M 26 + + 70% 4 250 +14 +/+/+/+ 640,000 2-3 + + 75% 4 100 +18 +/+/+/+ 0

Patient is rapidly deteriorating.

ISP F 23 + + 80% 4 50 +20 - /+I-I+ 0 1 + + 5% 0 950 NEG - /-I-/ - 10


ISP M 33 + + 90% 4 100 +17 +/+/+/+ 1-2 Patient left program, practiced unsafe sex, continued smoking and died at 36 months.

ISP M 28 + + 95% 4 25 +18 +/+/+/+ 0 0 + + 5% 0 900 -1 - I-/ -I - IO


MT M 23 + + 80% 4 120 +16 - I -I-/ - 640,000 3 + + 50% 2 100 +18 +/+/+/+ 1-2

Patients condition is getting worse.

MT F 32 + + 85% 4 150 +16 - I -I-/ - 950 6 + + 30% 2 350 +15 - I -I-/ - 7

Patient has improved.

p M 15 + + 90% 4 20 +20 +/+/+/+ 0 Patient died after 2 months.

p F 37 + + 85% 4 100 +18 -1-1-/ - 355,000 2 + + 70% 3 210 +16 - I -I -I - 3-4

Patient has improved.

ISP M 25 + + 100% 4 0 +20 +/+/+/+ 0 0 Patient died after 5 months.

GRAPH# 1

VIRAL FREE STATE

100% XX X xx xxxx xx

75%

X * 50%

25% Y* Y*

Y* 0* Y*Y*Y* O* 0* X * O*

X y X

Y*

Y* O*

Y*

0* 0* O*

O*Y X X

xx

YX

0 y

yyy

y

OY X"

Y* O*

4 6 8 IO 12 14 16 18 20 22 24 26 28 30 32 34 36 TIME (Months)

X - lmmuStim/CAP lmmunological Protocol

y - Mixed Therapy (MT) 0 - Placebo * - Deceased

DISCUSSION

The ISP continues to show greater and greater efficacy in the treatment of HIV/AIDS. At this time, with an 80% viral free rate we believe this protocol to be the most effective treatment available at this time.

Further, 100% of ail treated patients reported a marked improvement in their quality of life. This, of course, can not be said of the other medicines and approaches.

X. CONCLUSION

While we know that ISP is no cure or super bullet, it is evident that we are close to at least finding a means whereby a patient can live a relatively normal life and probably live until he/she reaches an age that would be normal for one's life expectancy.

As scientists and physicians we must continue to explore all avenues for the benefit of the patient.

TABLE#2

PATIENT SUMMARY OF VIRAL FREE STATE

PROTOCOL Ave.# % Viral Percent # of Patients Months Free Imnrovement Deceased

ImmuStim/CAP 45 11.9 80.0% 79.0% 4 Immunological Protocol

Mixed Therapy

Placebo

40 31.4 20.0% 51.6% 26

15 0 0% 13.3% 13

SUMMARY OF TREATMENT USING ImmuStimTM _ V/CAP IMMUNOLOGICAL PROTOCOL.

8.8%

65.0%

86.7%

When comparing the ImmuStim Protocol to the mixed therapies , we will briefly address the following:

I. EFFECTIVENESS II. SIMPLICITY III. COST/ COMPLIANCE

I. EFFECTIVENESS

To date, we believe that we have what appears to be the most effective program known against HIV/ AIDS.

1 OOo/c

* ISP (80% Viral Free in 11.9 months - Ave.) %

VIRAL FREE 503/c

• MT (20% Viral Free in 31.4 months - Ave.)

Months - 12 24

II. SIMPLICITY

There are no difficult schedules to maintain such as taking pills at set hours, etc. because the ISP is immunological and builds your general defenses

36 48 60

in order to kill the HIV and make the patient generally stronger. Even though ISP consists of IV treatments, they are convenient.

hi. COST/ COMPLIANCE - (Per Year)

** Mixed Therapy * ISP

$20,000 - $30,000 $40_000 - $50,000

** In addition to the therapy, most patients average 15 hospital days per year at an average of $450 per day for a total of $6,750 plus medicines that average approximately another $11,000. Many HIV/ AIDS patients pay up to $55,000 per year.

* This does not include travel, hotel accommodations, etc. and is based on normal ambulatory treatment. One .can figure from $50 -$100 USD per day for room and board. Airfare from Miami, Florida is approximately $300 USO.

REFERENCES

o Caplinger, G.E., "Immune-Therapy As Primary Therapy," B WI Press, May 1990

o Caplinger, G.E., ''The Utilization of Amino Acids in the Treatment of Chronic Degenerative Disease," (Manual) 1988

• Caplinger, G.E. and Pena, Claudio_ '~Treatment of HIV/ AIDS Infected Patients with a Biological Response Modifier ImmuStim-V'' Salud Integral, Vol.I, No. 1, August 1995

o Clark, Hulda, "The Cure for I-ITV and AIDS," Promotion Publishing, 1993


DISCLAIMER



CDD's, Cancer and HIV/ AIDS vary from person to person and so does the results. No results are, or should be considered typical or expected. As with all medicines and protocols, the results will vary from patient to patient.

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