Question and Answer
17^th March 2005

What is the purpose of this RECEPTOL Question and Answer Discussion?

In our first discussion towards the later part of last year, we introduced RECEPTOL® and talked about its general application to good health and well-being. Tonight, we want to go a little further and start talking about specific conditions that RECEPTOL® can help with, by taking information from the public domain. In future conference calls we hope to discuss other conditions that RECEPTOL® can help with, but tonight we are going to talk about Allergies, what are they, how do they affect us, and what we can do to prevent allergies making a mess of our lives, using traditional treatments as well as understanding the unstable biochemical mechanisms in our bodies that are caused by allergens and how RECEPTOL® balances these chemical processes out.

Now beware, that for ‘us' to make some sort of link between RECEPTOL® and allergies, we have to use some medical terminologies to describe the processes going on in our bodies. We can't just make these comments about allergies without substantiating our words.

What are allergies?

Allergies are caused by an oversensitive immune system, which leads to a misdirected immune response. The immune system normally protects the body against harmful substances, such as bacteria and viruses. In contrast, an allergic reaction is when the immune system reacts to substances (allergens) that are generally harmless and in most people do not cause an immune response.

What are these allergens?

Some of the most common allergens are:

• dust mites (tiny insects that live in dust) a protein found in the dander (dry skin), saliva (spit), or other things from some animals
• grass, flower, and tree pollen (the fine dust from plants)
• mold and mildew (small living things that grow in damp places)
• foods, such as milk, wheat, soy, eggs, nuts, seafood, and legumes which include peas, beans, and peanuts, or
• latex

However, these inhaled allergens are our topic of discussion.

OK, so what are these inhaled allergies causes by?

The most common inhaled allergen is dust! More precisely, dust mites and their wastes (every house has them, no matter how clean), and during spring time pollen i.e. hayfever is more predominant.

As an aside, symptoms are generally worst in the early morning, for 2 reasons:

• pollen counts are highest
• you've been sleeping for hours in a room filled with dust and/or mold

What happens in the body during an-allergic reaction?

In a person with allergies, the first exposure to the allergen triggers the immune system to recognize the substance. Any exposure after that will usually result in symptoms.

When an allergen enters the body of a person with a sensitized immune system, histamine and other chemicals are released by certain cells. This causes itching, swelling, mucus production, muscle spasms, hives, rashes, and other symptoms.

In its attempt to protect the body, it creates specific IgE antibodies to that food. The next time the individual is exposed to that airborne allergen, the immune system releases massive amounts of chemicals and histamines in order to protect the body. These chemicals trigger a cascade of allergic symptoms that can affect the respiratory system, gastrointestinal tract, skin, or cardiovascular system.

What are the common symptoms of a reaction?

Symptoms vary in severity from person to person. Most people have symptoms that cause discomfort without being life-threatening. A few people have life-threatening reactions (called anaphylaxis).

Symptoms range from a tingling sensation in the mouth, swelling of the tongue and the throat, difficulty breathing, hives, vomiting, abdominal cramps, diarrhea, CLEAR runny nose and sneezing, itchy or stuffed nose, itchy and runny eyes, lethargy, asthma drop in blood pressure, loss of consciousness, to death. Symptoms typically appear within minutes to two hours after the person has been exposed to the allergen which he or she is allergic.

What is the best treatment for allergies?

Your doctor will probably suggest ways to stay away from the allergen or prescribe a medicine for you to try. Allergy medicine can be pills, liquids, or even sprays for your nose. If your allergies aren't too bad or if you can avoid the allergen completely, you might not need to take medicine - staying away from the allergen might be enough to control your allergy.

If your symptoms don't get better by staying away from allergens and taking medicines, an allergist might recommend allergy shots. These shots make your immune system less sensitive to the allergens and can make your symptoms better.

Is there a cure for allergies?

Currently, there are no medications that ‘cure' allergies, but various treatments including anti-histamine drugs and Mast Cell Stabilizers are used to relieve symptoms. However, strict avoidance of allergens is the only way to prevent a reaction.

How do these drugs relieve allergy symptoms?

Firstly, anti-histamines are just that, they block to histamine chemicals that are produced from a IgE covered host or mast cells in an allergic reaction, rendering them inactive. So that is anti-histamines.

Secondly, Mast-cell stabilizers are another allergy medication option. These medications work by preventing mast cells from setting the allergic reaction into action. A mast cell can be thought of as a balloon filled with chemical mediators: when an allergy-causing pollen attacks, the mast cell bursts, releasing numerous chemicals. Among these chemicals are histamine and many others that contribute to itching, redness, and swelling. A mast-cell stabilizer that keeps all of those chemicals from spilling out can be extremely helpful in preventing an allergic reaction from starting. However, it must be used before the allergic reaction occurs.

Finally, in more severe allergic reactions, adrenaline based drugs, are the best type of medications of choice.

What are the alternatives to these current drug treatments for allergic reactions?

Various allergy and asthma universities and research centers in Europe and the United States are investigating the option of modulating cytokine levels in the body during an allergic reaction. It is well understood that these cytokine levels become unstable during allergic reactions and may be the triggers that produce these allergy symptoms. If it would be possible to stabilize these cytokine levels it may reduce or eliminate allergy symptoms.

RECEPTOL has Proline-Rich Polypeptides that are used in the production of many-many cytokines such as TNF-alpha that modulate cytokine levels and thus indirectly aids in the natural control of cytokine production, which has an effect on our immune system.

It has been realized early on that manipulation of the cytokine network may interfere selectively with specific functions. This prospect has created a lot of excitement and scientists are working on many different applications. RECEPTOL is just that. It modulates or stabilizes an overactive or suppressed immune system by ‘normalizing' the cytokine levels in the body. Various laboratories have investigated INTERLEUKIN4 and other cytokines which are involved in allergy and asthma.

What are these cytokines?

Cytokines are soluble proteins which are predominantly produced by cells of the immune system. They are related to hormones, but have usually local rather than systemic functions. Immune cells communicate with each other and with the surrounding tissue by secreting cytokines, and by expressing receptors which allow themselves to get stimulated by cytokines. The cytokine network is an important communication system involved in regulating and coordinating immunity.

What cytokines are altered during an allergic reaction?

Allergy develops if a particular cytokine is produced while an allergen enters the body and the body recognizes this foreign invader. If this cytokine, called ‘interleukin-4' is present during such a contact, an allergic immune response is initiated. The immune system gets is right most of the time and nearly all people react against parasites and ignore allergens, but those who react in this way to an allergen develop allergy against this specific stimulus. Allergen plus INTERLEUKIN4 leads to allergy.

However, INTERLEUKIN4 is not the only important cytokine in allergy. INTERLEUKIN13 is unable to shift the immune system towards allergy. In many cases INTERLEUKIN13 is even the more important cytokine, since it is produced for a longer time and to higher levels than INTERLEUKIN4. Since INTERLEUKIN4 and INTERLEUKIN13 are important for maintaining and organizing allergic immunity, an inhibitor would be expected to be therapeutically useful. A cytokine modulator, such as RECEPTOL, naturally can modulate the instability in these Interleukin-4 and Interleukin-13 levels.

What scientific studies have validated these ideas?

In controlled laboratory animal models with mice have suggested that inhibiting INTERLEUKIN-4/INTERLEUKIN-13 is useful in reducing the symptoms of asthma. Scientists have shown that controlling the levels of mouse INTERLEUKIN-4 completely prevented allergic sensitization in a non-asthma situation. Now scientists are trying to use cytokine inhibition for curing rather then preventing allergies. RECEPTOL®, a peptide-based cytokine inhibitor, can suppress these INTERLEUKIN-4/INTERLEUKIN-13 levels and suppress over-reactive immune system that lead to allergy symptoms.

What human models have validated these ideas?

Many anecdotal and testimonial reports have indicated that RECEPTOL® can help reduce the symptoms of allergies. For example, many reported cases within the GLOBALCEUTICALS INT'L INC. family have shown to have their allergy symptoms relieved. In fact the first observable health benefit in taking RECEPTOL® is the relief of allergies. Generally, we can hear about all the scientific mechanisms of how RECEPTOL® works in the body, but until people experience these benefits themselves, people are usually not convinced.

Are there any other cytokines and processes involving cytokines involved with allergies in humans and mammals?

Yes. INTERLEUKIN-4 and INTERLEUKIN-13 are by no means the only cytokines involved in allergy. Other relevant factors are for example INTERLEUKIN-5, which is responsible for asthmatic symptoms, and INTERLEUKIN-9, which is enhancing many disease-associated features of asthma. A special class of cytokines are the chemokines, these attract inflammatory compounds into the tissue, and cooperate to organize inflammatory processes in asthma.

We are interested to understand the molecular interaction between pollutants and the immune system. We could indeed show that specific substances from the group of polycyclic aromatic hydrocarbons especially in city centers, commonly called SMOG, are able to up-regulate expression of INTERLEUKIN-4. Scientists now are continuing their investigations of several other cytokine and chemokine promoters for effects of these components.

Understanding these mechanisms in polluted city centers would allow to further identify which substances in pollutant particles are actually interfering with immune function, and may require monitoring and regulation. The identification of new molecular mechanisms for modulating expression of chemokines and cytokines may even reveal new targets for therapeutic manipulation of the cytokine network, especially in asthmatic persons in urban centers.

Aside from all this heavy chemistry about cytokines, what do you think is going to happen in the next few years in the application of natural products such as RECEPTOL® to specific health conditions?

Basically, as far as I can see, three things will happen in the next few years.

1. We will keep the status-quo in pumping trillions of dollars into dealing with peoples health problems with synthetic or biochemical drugs, or
2. The big companies will start incorporating more and more natural products in there drug production, as long as they can protect their intellectual property, or
3. Natural products will become more and more used to help people with their health concerns, as long as there is enough clinical data to support their structure and function claims.

Scientists are currently working on developing new synthetic drug systems that stabilize cytokine function...that's right synthetic chemicals produced in a test tube to artificially suppress the symptoms of allergies and asthma. These artificial drugs can be detrimental to our health of you take enough of them for extended periods of time.

We all know the fine print that you get when you get a medication for a particular ailment, it tells us or all the harmful things that could happen to us should we take this drug... but wait! Natures goodness that delivers natural solutions to medical diseases, is now harnessed in RECEPTOL® and we ‘may' now have the answer to Allergies, naturally, with no side effects, at least that is the consensus from the people that have taken RECEPTOL® for allergy relieve.

It tastes good and corrects the cytokine imbalances that are caused by Allergens. We spend billions of dollars looking in the wrong places from answers to our health concerns. Nature has that answer, but since you cannot hold a product patent on natures products the is not enough money in it for the big pharmaceutical companies.

Some large companies are showing an interest in using natural products, which is promising, but they would not say that they are getting them from nature or everybody else will start to copy it. However, it is important in GLOBALCEUTICALS INT'L INC. to help people with there health conditions as cheaply as possible. Let's get back into the mode of helping people with their health rather than help them unload the money in there pockets.

So get your RECEPTOL® today and help treat allergies...naturally.

Do you have any final comments about RECEPTOL and Allergies?

Currently, RECEPTOL® is the only peptide product that can modulate cytokine levels in the human body and mammals.

RECEPTOL® not only helps with Allergies but remember RECEPTOL® has wide ranging health benefits to us all. Just take the spray twice a day and you should feel better throughout the day. It's inexpensive but effective. The GLOBALCEUTICALS INT'L INC. philosophy is to help all of us with our own health conditions, and do this naturally and inexpensively. Nature already has the answers to our health problems, now that scientists are continuing to find these answers in nature lets all get well and enjoy our lives.

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RECEPTOL Sections

• RECEPTOL Product Information
• RECEPTOL Research
• RECEPTOL FAQ
• RECEPTOL Testimonials
• RECEPTOL Interviews

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Seldom is there the opportunity to introduce a product that demonstrates such an enormous overall impact on the body. RECEPTOL® is your body’s most valuable partner to protect your system from the attack of destructive pathogens and to help the body to repair itself into its most healthy state.

We don’t KILL anything • We just make it go away!

see also: • RECEPTOL home page

As a preventative, RECEPTOL^® has been a wonderful support against common flues and viruses, which plague the elderly as well as children in school where exposure to infection can bring germs home to the rest of the family. Testimonials report marked improvement against the flu season.

RECEPTOL^® will soon become the new must-have dietary supplement that every household will want to have on hand. The key to good health depends on a strong and resilient immune system.

RECEPTOL^®used in sequence with Miracle Growth Factor Plus® is your good-health partner in life!

For boosting the immune system and promoting healing, the process starts with detoxification. The human body will naturally begin to detox with a daily regimen of exercise, adequate rest and a quality diet that includes at least 5 servings of fresh fruits, and vegetables, plenty of pure water and the complete elimination of refined sugars, flours and highly processed foods. RECEPTOL^® addresses the detoxification process for infectious agents. Detoxification from heavy metals is addressed by our Cheyene-Chiä Healing Pads soon to be available at this website, enabling the body to completely detoxify. For general use it is suggested that RECEPTOL^® be used for 2 weeks before initiating use of Miracle Growth Factor Plus®. For maximum benefits from both products they work synergistically and should be used together.

Its value far exceeds the price, yet in conformity with Healing Community goals, we are able to offer RECEPTOL^® at a low introductory price to give you an opportunity to use this powerful product.

For more information regarding RECEPTOL click here (click here)

For more information regarding Miracle Growth Factor Plus (click here)

Concerns about HAART
(Highly Active Anti-Retroviral Therapy)

HAART is the therapy, composed of multiple anti-HIV drugs, that is prescribed to many HIV-positive people, even before they develop symptoms of AIDS (and without considering that many will never develop these symptoms). The therapy usually includes one nucleoside analog (DNA chain terminator), one protease inhibitor and either a second nucleoside analog ("nuke") or a non-nucleoside reverse transcription inhibitor (NNRTI).

Adverse Effects, in General

The list of side effects of HAART (Highly Active Antiretroviral Therapy) is so long, that it is impossible to categorize all of them. Further, some papers document side effects in a number of categories. The quotes below illustrate this.

"There is also increasing recognition that adverse events associated with antiretroviral treatment remain an important source of morbidity and even mortality, such as in advanced disease, in which non-AIDS serious adverse events continue to outweigh AIDS-related events in frequency and overall detrimental effects on quality of life."

Complications of antiretroviral therapy. XV International AIDS Conference. 2004 Aug 27.

Adverse Effects with Nucleoside Analogs ("Nukes")

Also see information specifically related to AZT in <a href="http://www.aras.ab.ca/azt.html">azt.html</a>.

"this rare but often life-threatening syndrom, now named ‘severe nucleoside-associated lactic acidosis' (NALA) has been reported increasingly often. Hepatic steatosis [loss of fat in liver] and lactic acidosis are thought to be caused by nucleoside reverse-transcriptase inhibitor (NRTI)-associated mitochondrial toxicity...Low levels of hyperlactatemia have been reported in 21% of NRTI-treated patients, although the majority of these patients are

"Bristol Myers Squibb (BMS) has chosen to inform doctors of rapidly ascending muscular weakness as new symptom of nucleoside-related lactic acidosis and hyperlactataemia

 

Rapidly ascending neuromuscular weakness associated with nucleoside analogues. HIV Treatment Bulletin. 2001 Oct;2(8).

"Pancreatitis occurs with a frequency of 1 to 7% with the currently recommended doses of didanosine...Our analysis demonstrated that the use of hydroxyurea was associated with an adjusted fourfold increase in the risk of pancreatitis compared with patients on didanosine alone...There was one fatal case in a patient on didanosine + stavudine + hydroxyurea "

 

Adverse Effects with Protease Inhibitors

Protease Inhibitors were described as miracle drugs when they first were made available in late 1995. However, the miracle turned out to be a mirage, as a whole range of new side effects, particularly metabolic abnormalities, were discovered. As with all AIDS drugs, this should not have been a surprise, because they are tested for only a short time, in order to rush them to market.

"Participants who initiated therapy with a protease inhibitor were 2.02 times more likely to die than those who did not start therapy with this class of drug "

Hogg R et al. Rates of Disease Progression by Baseline CD4 Cell Count and Viral Load After Initiating Triple-Drug Therapy. JAMA. 2001 Nov 28;286(20):2568-77.

Blood Disorders

HAART can be toxic to blood because it almost always includes one or two nucleoside analogs, drugs like AZT that are notorious for their toxicity to red and white blood cells and blood cell production. Various forms of anemia are very common and sometimes are irreversible.

Bone Disease

HAART can have debilitating effects on the bones of people that take these drugs.

"Bone disorders in HIV-1 patients treated with highly active antiretroviral therapy (HAART) are an emerging issue...After approximately 27 months of treatment with indinavir (800 mg three times a day), zidovudine [AZT] and lamivudine [3TC], a 56-year-old HIV-1-infected bisexual man noticed thickenings on almost all fingers of his hands. He also noted several small protrusions at the costosternal [breastbone] junctions...After the introduction of indinavir [a protease inhibitor] in June 1998, the patient experienced myalgia [muscle pain], arthralgia [joint pain], dry skin, body hair loss, and ingrown toenails developed. The patient has also been taking trimethoprim-sulfamethoxazole...

 

Click the link below to view the report in a PDF format.

AZT: Unsafe at Any Dose?

Project Application for IRB & Ethics Committee

1. Project Title: Efficacy Trails of RECEPTOL, a pure natural product on 50 AIDS Patients based on Indian FDA & ICMR recommended protocols

2. Principal Investigator:

1. Dr. N.K. Hase, MD Professor & Head: Dept. of Medicine
2. Director General: National AIDS Control Organization

3. Investigators:

1. Dr. Alka Gogate, Project Director, Mumbai AIDS Society
2. Dr. G.C. Rajadhyaksha, Assoc. Prof. of Medicine
3. Dr. Mayank Shah, President, Helium Hospital
4. Dr. Neelam Redkar, Head, HIV Unit
5. Dr. Sandhya Saharan, OBGY Specialist
6. Dr. Asha Shah, Hematologist
7. Ms. Nirzari Parikh, MS (Cambridge UK): Chief Technical officer
8. Dr. Suresh Advani, Chief Oncologist (Consultant of Study)

4. Introduction and background of the Project

4.1 Definition of the Study with Brief Introduction:

This study will test the safety and effectiveness of RECEPTOL® Liquid for treating people infected with HIV. Cell fusion of HIV particles with human white blood cells, particularly CD4 cells with the aid of glycoprotein epitopes on the viral wall. It is believed that the informational proteins in RECEPTOL® are active in mitigating cell fusion by impacting the HIV glycoprotein' ability to attach and fuse with CD4 cells.

4.2 Aims & Objectives of the project:

This study will determine what effect of oral administration of RECEPTOL® Liquid has on viral load, CD4, CD8 cells and HIV/AIDS symptoms in the patients.

4.2 Place of Study: LTMMC & General Hospital, Sion, Mumbai 400 022

4.2 Duration of the Study: 12 Weeks

5. Study Description

5.1 Design:

Phase III Efficacy Study for Receptol is designed for HIV-positive patients between the ages of 18 and 60. Candidates will have a medical history, physical examination, blood and urine tests, and chest X-ray, and possibly other tests as determined by the clinician in guidance with the principal investigator.

Participants will receive RECEPTOL® Liquid in pump spray form. Patients will be taught to self-administer RECEPTOL®. Frequency of administration is 4 times per day. Each administration will consist of three (3) spays directly on the buchal mucosa (inner cheek). Each pump of the spay delivers 0.7ml of RECEPTOL®. This study will continue for 12 weeks.

Participants will be evaluated in the clinic once a week through the first 4 weeks of therapy, then every 2 weeks for the remaining 8 weeks of the initial study. They will be asked about side effects of treatment and may have a physical examination. Blood tests to measure CD4 cells and HIV viral load will be done at each evaluation.

Further Study Details: This study will involve a single arm, open label, 12-week study in 50 subjects to determine increase of CD4 and CD8 counts associated with RECEPTOL ® supplementation in subjects with HIV / AIDS.

This is a study to determine the efficacy of RECEPTOL ® given over twelve (12) weeks. The study is designed to investigate potential for RECEPTOL® therapy to reduce viral load and increase CD4 levels. As mentioned the primary endpoints of the study include effect of this therapy on markers of HIV disease including the HIV-viral load and CD4 cell counts along with general well being of the patients.

5.2 Methodology: Sample size & Sampling Method

Total Enrollment: 50

Eligibility: Genders Eligible for Study: Both Male & Female Subjects

5.3: Definition of subject/material to be used:

Criteria

a) INCLUSION CRITERIA:

• Subjects should be between 18 and 60 years of age.
• Documentation of HIV infection by any licensed ELISA test.
• Subjects must have CD4 count greater than 100 cells/mm(3)
• Subjects will have measurable HIV viral load.
• Subjects must have the ability to give informed consent.
• Willingness to give informed consent.
• Willingness to be able to make follow up visits once per week for the first four weeks and once every other weed for eight weeks

b) EXCLUSION CRITERIA

• Pregnant or nursing women, women of childbearing potential not using an adequate method of birth control
• Subjects with kidney disease or serum creatinine greater than 1.5 mg/dL
• A history of hepatic cirrhosis.
• Congestive heart failure.
• Evidence of a severe or life-threatening infection.
• Treatment within the last 2 months with systemic gluco-corticoid steroids
• Any medical condition that, in the opinion of the Principal Investigator or Study
• Chairperson would preclude the inclusion of a patient onto this study.
• Active systemic infections other than hepatitis C and HIV.
• Hemochromatosis, autoimmune hepatitis (ANA greater than 160) except history of drug-associated hepatitis with discontinuation of the causative agent.
• Liver disease caused by reasons other than hepatitis C like HBV, HDV, Wilson'sHepatic mass suggestive of hepatocellular carcinoma.
• Current alcohol or substance abuse that potentially could interfere with patientcompliance.
• Any systemic illness that will make it unlikely that the subject will be able toreturn to LTMMC, Sion Hospital, Mumbai Clinical Research for the required study visits.
• Organ transplant recipient.
• Preexisting uncontrolled seizure disorder.
• No subjects using long term systemic corticosteroids, immuno-suppressive, or

5.4 Parameters to be studied at the initiation of the study

Blood tests to measure CD4 cells and HIV viral load will be done along with other examinations as per the inclusion criteria for the patients given above.

5.5 Parameters to be studied at follow up along with duration of follow up

Blood tests to measure CD4 cells and HIV viral load will be done as per the detailed Methodology along with study protocols given above for a duration of 12 weeks.

5.6 Organisation of work elements: Names of the Milestones

PROJECTED SCHEDULE PHASES:

Phase I :

Subject recruiting, Document drafting

Hospital Ethics Committee Clearance & Duly Signed Consent Forms by the Patients

Phase II (4weeks-Subjects to visit clinic once per week):

Week 1

• Subjects will deliver medical case history records to LTMMC, Sion Hospital, Mumbai to initiate the Case Report Form
• Explanation of study, study is an Open Study
• Informed Consent Form executed .
• Study subject may complete Quality of Life Survey
• Initial Physical Examination including Vital Signs, Height, Weight, temperature and will assess the Skin, Heart, Lungs, Neuro., extremities & Chest X-rays
• Initial blood work to establish baselines (CD4, CD8, HIV Viral Load)
• Study subjects directed in self administration of RECEPTOL®
• Initial administration or RECEPTOL® done in clinic
• Study subjects to self-administer RECEPTOL® as directed three (3) sprays to the buchal

mucosa every four hours during waking hours

Week 2 (Subjects using RECEPTOL® one week)

Study subjects return to clinic for blood work and evaluation (CD4,CD8 Count)

Week 3 (Subjects using RECEPTOL® two weeks)

Study subjects return to clinic for blood work and evaluation (CD4,CD8 Count)

Week 4 (Subjects using RECEPTOL® three weeks)

Study subjects return to clinic for blood work and evaluation (CD4, CD8, HIV Viral Load)

Week 5 (Subjects using RECEPTOL® four weeks)

Study subjects return to clinic for blood work and evaluation (CD4, CD8, HIV Viral Load)

Subjects complete second Quality of Life Survey

Phase III (8 weeks-Subjects to visit clinic every other week, once in 15 days):

Week 7 (Subjects have been using RECEPTOL® 6 weeks)

Study subjects return to clinic for blood work and evaluation (CD4, CD8, HIV Viral Load)

Week 9 (Subjects have been using RECEPTOL® 8 weeks)

Study subjects return to clinic for blood work and evaluation (CD4, CD8, HIV Viral Load)

Week 11 (Subjects have been using RECEPTOL® 10 weeks)

Study subjects return to clinic for blood work and evaluation (CD4, CD8, HIV Viral Load)

Week 13 (Subjects have been using RECEPTOL® 12 weeks)

Study subjects return to clinic for blood work and evaluation (CD4, CD8, HIV Viral Load)

Subjects complete final Quality of Life Survey

Phase IV

Data analysis and report generation

Study results presented to ICMR & DCGI

Starting Date: February 7, 2005

Expected date of Completion: Approx. 4 months from the starting date

5. 7 Staff to be appointed (if any)

6. Work Already Done in the field

RECEPTOL^®- demonstrated in-field and clinical use with more that 2000 HIV infants, children and adults in twelve countries. There have been no known exceptions to the ability to affect the progression of many chronic degenerative diseases for which it has been used. In many cases, the formula has induced what appears to be complete and lasting cellular recovery.

RECEPTOL^® has shown to be effective in treating many different diseases and condition. However, it is prudent to focus attention on a few well-known diseases. Initially, Rheumatoid Arthritis was the selected disease to put under the microscope. The success of treating this autoimmune condition led to the selection of a high profile disease - HIV.

Receptol treatment of - HIV: African Trial Results Report

Phase 1 - HIV trial

Population: 12 cohorts, term: 30 days and moderate control of product use. The patients in this study should be presumed to have had previous exposure to chemo-therapy (AZT). Neither the doctor nor patients were made aware of the positive potential of this product. A balanced diet of carbohydrates, proteins, fats, vitamins and minerals were administered in conjunction with the treatment.

Results

Weight Gain

• 10 out of 12 gained weight during the thirty-day trial period.
• Of the 10 that gained weight, 7 (70%) gained an average of 6 lbs
• 5 patients gained 6 lbs in one month, while 2 others 5.5 and 6.6 lbs respectively
• the highest weight gain of 12 lbs was recorded for a patient who had been HIV positive since 1986 (10 years)

Number of Patients	Number of lbs Gained
1	+12.0
1	+6.5
5	+6.0
1	+5.5
2	+2.0
1	+0.0
1	-0.4

Diarrhea

• 8 out of 10 patients had various levels of diarrhea (mild, moderate or severe) at the beginning of the trial period
• Of the 8, 5 patients (62%) went from varying levels of diarrhea severity to NO diarrhea.
• The 1 patient without weight gain experienced total elimination of severe chronic diarrhea and a return to solid stool formation.

Nausea

• 8 out of 12 patients had various levels of nausea at the beginning of the trial period.
• Of the 8, 5 patients (62%) went from varying levels of severity of nausea to No nausea.
• Of the remaining 3 patients, with some degree of nausea, 2 experienced a reduction in the severity of their symptoms.
• 9 out of 10 patients, who reported fatigue symptoms at the beginning of the trial, experienced an increase in their level of energy.
• 3 out of 10 experienced a significant increase in energy, from initial varying levels of fatigue to NO fatigue.

Cough

• 4 out of 12 had either a mild to moderate cough at the beginning of the trial
• 2 of the 4 reported NO cough at the end of the trail period.
• Of the remaining 2 individuals, 1 reported a reduction in the severity of his cough.

Symptoms Assessment Score

• All 12 patients experienced an improvement in their overall symptoms assessment score.
• The average reduction approached 2/3 (63%) - Dr Brandt.

Phase 2 - HIV trial

Phase 2 of the study on HIV was completed in Nairobi, Kenya.

Objectives: To demonstrate, under clinical conditions, the safety and efficacy of info protein supplementation in patients known to have advanced disease (HIV/AIDS), compromised immune resources and limited access to conventional treatment.

Population: 30 cohorts, term: 30 days and moderate control of product use.

Considerations: Unless otherwise noted, the patients in this study should be presumed to have no previous exposure to chemotherapy (AZT). Some patients could not refrigerate the product after opening, therefore exposing it to the denaturing effect of bacterial contamination.

The patients were not made aware of the positive potential of the product.

Results

• The product appeared to be free of side effects and generally well tolerated by the participants. Some signs, consistent with detoxification, were noted but resolved when the patients increased their water consumption.
• The product demonstrated significant value by reducing or resolving the symptoms of opportunistic infections most commonly associated with the dynamic of HIV/AIDS.
• Patients often experienced weight gains as part of an overall pattern of positive response.

Summary

Positive clinical results observed in the Nairobi patients.

Phase 3 - HIV trial

Phase III study on HIV Patients in Rwanda.

Objectives: To demonstrate, under clinical conditions, the safety and efficacy of info-protein supplementation in patients known to have advanced disease (HIV/AIDS). Cohorts were all symptomatic, ambulatory, compliant and native to anti-retroviral therapy.

Population: 60 cohorts, term: 365 days and moderate control of product use.

Considerations: All cohorts receive oral supplementation of RECEPTOL^® every 6 hours for a period of 365 days. Some patients could not refrigerate the product after opening, therefore exposing it to the denaturing effect of bacterial contamination.

The patients were not made aware of the positive potential of the product.

Results

• The product appeared to be free of side effects and generally well tolerated by the participants. Some signs, consistent with detoxification, were noted but resolved when the patients increased their water consumption.
• The product demonstrated significant value by reducing or resolving the symptoms of opportunistic infections most commonly associated with the dynamic of HIV/AIDS.
• Patients often experienced weight gains as part of an overall pattern of positive response.
• After 1 day of use there was a moderate level of relief of fever and diarrhea.
• After 14 days of use all patients experienced relief of skin lesions, mouth thrush, fever, diarrhea, tuberculosis.
• After 90 days of use all patients experienced relief of all symptoms.
• After 330 days all patients are still not experiencing any negative symptoms.

Discussion

In brief, the patients recovered very quickly but complain of INTENSE HUNGER AND THIRST. It is VITAL TO INTERVENE BY GIVING PROTEIN SUPPLIMENTATION to be able to observe the body reconstruction as most patients are very poor and have low protein intake. Generally speaking there is an excellent recovery for all patients that have been on the product but the EXTREME HUNGER is hindering the weight gain process. - Dr. Rusibira, Internal Medicine Specialist.

Summary

Positive clinical results are continually observed in the Rwanda patients even after 12 months of completion of trails.

7. References: Xerox copy attached.

8. Comments by Bio-Statistician: Drug Controller General of India on ICMR recommendation has already approved 50 AIDS patients trails for Receptol in India based on US FDA and NIH guidelines.

 

Click the link below to view the report in a PDF format.

Bovine Colostrum: its dietary supplementation role in improvement and modulation of human immune indices

 

Click the below link to view the report in a PDF format.

Colostrum and HIV Virus/AIDS

COLOSTRUM & COLOSTRUM DERIVATIVE RESEARCH

The newborn for whom the colostrum is intended is a blank tablet, immunologically speaking. It needs protection from the environment it has just entered, and it needs it immediately if it is to survive. Therefore colostrum, whether it is from a cow or a human, is loaded with everything the newborn needs to survive in the hostile world. Cows, unlike humans, are unable to receive immunoglobulins across the placenta to "prime" the immune system before birth, so they need a massive dose of immunoglobulins immediate after birth. Bovine colostrum thus contains much more Immunoglobulin G (IgG) than human colostrum, which contains predominantly Immunoglobulin A (IgA). IgG provides passive systemic immunity whereas IgA provides more localized immunity. Bovine colostrum is able to impart passive immunity not only to calves but to humans as well against a broad spectrum of pathogens as well as nonspecific immune support against all pathogens, including bacteria, viruses, fungi and protozoan parasites. Colostrum also has the unique ability to modulate the immune system through the activity of colostrinin, a protein found only in colostrum, which can heat up or cool down the immune system depending upon what is needed by the host.

• Colostrum provides passive immunity against bacteria, viruses, fungi and protozoan parasites^34-48
• Lactoferrin, lactoperoxidase and lysozyme are non-specific bactericidal, virucidal and fungicidal components of colostrum^49-54
• Lactoferrin and lysozyme have been shown to act in concert with lactoferrin first binding to and removing the lipopolysaccharide protective coating of gram-negative bacteria (such as Vibrio cholerae (cholera), Salmonella typhimurium (food poisoning) and Eschericia coli), allowing lysozyme to enter the bacterial cell, causing lysis⁵⁵
• Lactoferrin is effective against HIV and Human Cytomegalovirus^56,57
• Colostrum alleviates Cryptosporidosis, a life-threatening diarrhea which occurs as a secondary infection in AIDS^58-60
• Colostrum contains complement factors and oligosaccharides which also provide non-specific antimicrobial protection^61,62
• Colostrum contains colostrinin^® (or PRP), a unique immunomodulatory peptide which causes the differentiation of thymocytes into active T cells and stimulates the differentiation of B cells and can also act to tone down on overactive immune system, such as is found in autoimmune diseases^63,64
• colostrinin^® also stimulates the production of interferon-beta (IFN ?) and tumor necrosis factor-alpha (TNF-?) by peritoneal cells⁶⁵
• Oral administration of interleukin-1beta (IL-1?) from colostrum causes a marked increase in the proliferation of peripheral blood mononuclear cells, indicating that colostrum stimulates the immune system⁶⁶
• Cytokines, such as tumor necrosis factor- alpha (TNF-?), interleukins (IL-1?, IL-1?, IL-6) and interferon (IFN?) in colostrum, stimulate the developing immune system in infants as well as the depressed immune system of aged individuals⁶⁷
• Colostrum stimulates the formation of cytokines, interleukins 1, 3 and 6 (IL-1, IL-3, IL-6), by blood leukocytes⁶⁸
• Transforming growth factor-beta (TGF-?) and interleukin-10 (IL-10), both found in colostrum, modulate the activity of monocytes and macrophages in organizing immune responses to pathogens, either turning them on or off depending on what is needed⁶⁹

• Lactoferrin from colostrum increase both motility and superoxide production by polymorphonuclear leukocytes (white blood cells), apparently making them more effective in warding off infections⁷⁰
• Colostrum can modulate natural killer cell activity by stimulating or inhibiting production of interleukin-2 (IL-2)⁷¹

Research References

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25. Monteleone, P, et al. Blunting by chronic phosphatidylserine administration of the stress-induced activation of the hypothalamo-pituitary-adrenal axis in healthy men. European Journal of Clinical Pharmacology 42(4):385-388 (1992). A follow-up to the previous study which indicated that long-term use of phosphatidylserine supplement can counter the effects of stress.
26. Benton, D, et al. The influence of phosphatidylserine supplementation on mood and heart rate when faced with an acute stressor. Nutritional Neuroscience 4(3):169-178 (2001). This study showed that phosphatidylserine supplementation can also improve the mood of subjects under stress. Obeid, LM, et al. Programmed cell death induced by ceramide. Science 259(5102):1769-1771 (1993). Sphingomyelin has been shown to be an important link in the signaling mechanism for controlling programmed cell death (apoptosis), cell growth and differentiation. The hydrolysis of sphingomyelin into ceramide acts to turn on tumor necrosis factor-alpha (TNF- ? ) and other cytokines, which in turn produces apoptosis. This has been used successfully in the treatment of leukemia.
27. Parodi, PW. Cows' milk fat components as potential anticarcinogenic agents. Journal of Nutrition (127(6):1055-1060 (1997). Some of the milk fats found normally in milk and colostrum have been show to have anticarcinogenic effects, including sphingomyelin and conjugated linoleic acid (CLA).
28. Dial, EJ, Lichtenburger, LM. A role for milk phospholipids in protection against gastric acid. Studies in adult and suckling rats. Gastroenterology 87(2):379-385 (1984). Phospholipids found in raw milk protect the stomach from excess gastric acid, thus providing protection from ulcers.
29.  Palmer, EL, et al. Antiviral activity of colostrum and serum Immunoglobulins A and G. Journal of Medical Virology 5:123-129 (1980). Virus-specific IgA was discovered in colostrum, including anti-polio antibody.
30. Ogra, PL, et al. Colostrum-derived immunity and maternal-neonatal interaction. Annals of the New York Academy of Sciences 409:82-95 (1983). Passive immunity to specific pathogens is passed from mother to infant via colostrum.
31. Brüssow, H., et al. Bovine milk immunoglobulins for passive immunity to infantile rotavirus gastroenteritis. Journal of Clinical Microbiology 25(6):982-986 (1987). Protection against rotavirus, a dangerous pathogen which can cause serious, even fatal diarrhea in infants, can be passed orally through milk or colostrum safely and effectively.
32. Ebina, T, et al. Passive immunizations of suckling mice and infants with bovine colostrum containing antibodies to human rotavirus. Journal of Medical Virology 38:117-123 (1992). Another study that confirmed that oral immunization via colostrum or milk against rotavirus was possible, safe and effective.
33. Stephan, W, et al. Antibodies from colostrum in oral immunotherapy. Journal of Clinical Chemistry and Clinical Biochemistry 28:19-23 (1990). An immunoglobulin preparation from pooled bovine colostrum was found to be very effective in treating severe diarrhea, such as often found in AIDS patients.
34. van Hooijdonk, AC, Kussendrager, KD, Steijns, JM. In vivo antimicrobial and antiviral activity of components in bovine milk and colostrum involved in non-specific defense. British Journal of Nutrition 84(Suppl.1):S127-S134 (2000). Lactoferrin and lactoperoxidase, both present in colostrum in large amounts, provide non-specific defense against a broad spectrum of pathogens, including bacteria and viruses. This is significant both for the protection of commercially important animals as well as humans.
35. Korhonen, H, et al. Bovine milk antibodies for health. British Journal of Nutrition 84(Suppl.1):S135-S146 (2000). Bovine colostrum provides safe, effective protection against many pathogens. This natural immune protection can be extended by hyperimmunizing cows against specific pathogens.
36. Solomons, NW. Modulation of the immune system and the response against pathogens with bovine colostrum concentrates. European Journal of Clinical Nutrition 56(Suppl.3):524-528
37. Kivinen, A, et al. Gastroprotective effect of milk phospholipids, butter serum lipids and butter serum on ethanol and acetylsalicylic acid induced ulcers in rats. Milchwissenschaft 1991:573-575 (1991). Another study that demonstrated the ability of milk phospholipids to protect the stomach from ulcers produced by stomach acid.
38. Lichtenburger, LM, et al. Nonsteroidal anti-inflammatory drug and phospholipid prodrugs: combination therapy with anti-secretory agents in rats. Gastroenterology 111(4):990-996 (1996). Combining phospholipid supplements with NSAID drugs reduces damage to the gastrointestinal lining and increases the therapeutic effect of the drugs.
39. Anand, BS, et al. Phospholipid association reduces the gastric mucosal toxicity of aspirin in human subjects. American Journal of Gastroenterology 94(7):1818-1822 (1999). Similar results were found when phospholipids were combined with aspirin.
40. Carlson, SE, et al. Lower incidence of necrotizing enterocolitis in infants fed a preterm formula with egg phospholipids. Pediatric Research 44(4):491-498 (1998). Necrotizing enterocolitis, a severe inflammation of the gut in newborn infants which causes some 4,000 deaths annually in the US, has a lower incidence when newborns are given formula containing phospholipids.
41. Sabin, AB. Anti-poliomyelitic substance in milk from human beings and certain cows. Journal of Diseases of Children 80:866-870 (1950). Seminal study by Dr. Albert Sabin, inventor of the oral polio vaccine, in which he discovered antibodies against the polio virus in colostrum.
42. Solomons, NW. Modulation of the immune system and the response against pathogens with bovine colostrum concentrates. European Journal of Clinical Nutrition 56(Suppl.3):524-528 (2002). The ability of colostrum to protect infants against pathogens, specifically those which cause gastroenteritis and severe diarrhea, makes it an ideal, cheap, safe and effective means of protecting children in those parts of the world where medical assistance is lacking or substandard and could save thousands of lives each year.
43. Ho, PC, Lawton, JWM. Human colostral cells: Phagocytosis and killing of E. Coli and C. Albicans. Journal of Pediatrics 93(6):910 -915 (1978). Cells found in colostrum are able to ingest and kill both E. coli and Candida.
44. Majumdar, AS, et al. Protective properties of anti-cholera antibodies in human colostrum. Infection and Immunity 36:962-965 (1982). Colostrum was able to prevent infection with cholera. Colostrum samples from India, where cholera is common, had much higher levels of anti-cholera IgA than those from Sweden, where cholera is rare.
45. Funatogawa, K, et al. Use of immunoglobulin enriched bovine colostrum against oral challenge with enterohaemorrhagic Eschericia coli O157:H7 in mice. Microbiology and Immunology 46(11):761-766 (2002). Colostrum can prevent infection against food-borne pathogens by preventing them from binding to the intestinal lining.
46. Widiasih, DA, et al. Passive transfer of antibodies to Shiga toxin-producing Eschericia coli O26, O111 and O157 antigens in neonatal calves by feeding colostrum. Journal of Veterinary Medicine 66(2):213-215 (2004). Feeding colostrum to calves provided protection against Shiga toxin-producing E. Coli, a particularly deadly strain of E. coli.
47. Acosta-Altamirano, G, et al. Anti-amoebic properties of human colostrum. Advances in Experimental Medicine and Biology 216B:1347-1352 (1987). In addition to its effectiveness against bacterial, viral and fungal infections, colostrum also provides protection against amoebic pathogens.
48. Akisu, C, et al. Effect of human milk and colostrum on Entamoeba histolyica. World Journal of Gastroenterology 10(5):741-742 (2004). Colostrum was found to provide protection against Entamoeba histolyica, the cause of amoebiasis, a serious, chronic illness characterized by dysentery, gastrointestinal ulceration and abscess formation and intestinal blockage in infants particularly.
49. Edde, L, et al. Lactoferrin protects neonatal rats from gut-related systemic infection. American Journal of Physiology: Gastrointestinal Liver Physiology 281:G1140-G1150 (2001). Lactoferrin protected neonatal rats from E. coli infection in the intestines. Lactoferrin plus lysozyme was bactericidal against the E. coli.
50. Qiu, J, et al. Human milk lactoferrin inactivates two putative colonization factors expressed by Haemophilus influenzae. Proceedings of the National Academy of Sciences USA 95:12641-12646 (1998). Lactoferrin prevents colonization of Haemophilus influenzae, the primary cause of otitis media and other respiratory infections in children, by inactivating two colonization factors expressed by the bacteria.
51. Hasegawa, K, et al. Inhibition with lactoferrin of in vitro infection with human herpes virus. Japanese Journal of Medical Science and Biology 47:73-85 (1994). Both human and bovine lactoferrin inhibit infection with human herpes simplex virus and human cytomegalovirus in cell cultures.
52. van der Strate, BW, et al. Antiviral activities of lactoferrin. Antiviral Research 52(3):225-239 (2001). Lactoferrin is effective against both DNA and RNA viruses, including rotavirus, respiratory syncytial virus, herpes virus and HIV, both by blocking cellular receptors and by directly binding to the viruses.
53. Andersson, Y, et al. Lactoferrin is responsible for the fungistatic effect of human milk. Early Human Development 59:95-105 (2000). Lactoferrin, through its iron-binding ability, is very effective against fungal infections with Candida and other fungi.
54. Samaranayake, YH, et al. Antifungal effects of lysozyme and lactoferrin against genetically similar, sequential Candida albicans isolates from a human immunodeficiency virus-infected Southern Chinese cohort. Journal of Clinical Microbiology 39(9):3296-3302 (2001). Lactoferrin plus lysozyme is very effective in killing nearly all oral strains of Candida, which is of particular importance to AIDS sufferers who are often unable to fight off Candida overgrowths, such as thrush.
55. Ellison, RT III, Giehl, TJ. Killing of gram-negative bacteria by lactoferrin and lysozyme. Journal of Clinical Investigation 88(4):1080-1091 (1991). Lactoferrin and lysozyme act together to kill gram-negative bacteria, such as Vibrio cholerae (cholera), Salmonella typhimurium (food poisoning) and Eschericia coli. The lactoferrin attaches to and destroys the cell wall of the bacteria, allowing the lysozyme to enter and lyse (burst) the organisms.
56. Harmsen, MC, et al. Antiviral effects of plasma and milk proteins: lactoferrin shows potent activity against both human immunodeficiency virus and human cytomegalovirus replication in vitro. Journal of Infectious Diseases172(2):380-388 (1995). Lactoferrin can protect against infection by HIV and human cytomegalovirus by blocking entrance into the body.
57. Berkhout, B, et al. Characterization of the anti-HIV effects of native lactoferrin and other milk proteins and protein-derived peptides. Antiviral Research 55(2):341-355 (2002). Bovine lactoferrin as well as peptides derived from lactoferrin blocks the entry process of HIV into cells.
58. Rump, JA, et al. Treatment of diarrhea in human immunodeficiency virus-infected patients with immunoglobulins from bovine colostrum. Clinical Investigator 70:588-594 (1992). Immunoglobulins from bovine colostrum were very effective in treating chronic diarrhea in AIDS patients from a variety of causes. Colostral immunoglobulins are highly resistant to digestion in the gastrointestinal tract.
59. Plettenberg, A, et al. A preparation from bovine colostrum in the treatment of HIV-positive patients with chronic diarrhea. Clinical Investigator 71(1):42-45 (1993). Another study which examined the use of immunoglobulins from bovine colostrum in the treatment of chronic diarrhea in AIDS patients. 40% of the study group experienced complete remission of symptoms and 24% partial remission.
60. Greenberg, PD, Cello, JP. Treatment of severe diarrhea caused by Cryptosporidium parvum with oral bovine immunoglobulin concentrate in patients with AIDS. Journal of Acquired Immunodeficiency Syndromes and Human Retrovirology 13(4):348-354 (1996). Another study which looked at the treatment of cryptosporidiosis diarrhea in AIDS patients with an immunoglobulin concentrate from bovine colostrum. Best results were found using a powdered form of the concentrate rather than in capsules.
61. Korhonen, H, et al. Milk immunoglobulins and complement factors. British Journal of Nutrition 84(Suppl.1):S75-S80 (2000). Bovine colostrum contains three main classes of immunoglobulin IgG (IgG1 75% and IgG2), IgM and IgA, plus hemolytic and bactericidal complement. Complement is a complex group of proteins which act in concert with antibodies to inactivate and/or kill pathogens.
62. Gopal, PK, and Gill, HS. Oligosaccharides and glycoconjugates in bovine milk and colostrum. British Journal of Nutrition 84(Suppl.1):S69-S74 (2000). Another way colostrum helps protect against infections is through the oligosaccharides and glycoconjugates it contains. These are complex sugars which compete for binding sites in the GI tract with pathogens.
63. Janusz, M, Lisowski, J. Proline-rich polypeptide (PRP) - an immunomodulatory peptide from ovine colostrum. Archivum Immunologiae et Therapiae Experimentalis 41:275-279 (1993). A unique, non-species specific polypeptide which plays an immunomodulatory role in the immune system. It can induce the differentiation of thymocytes into functional T-cells as well as increase the permeability of skin blood vessels. What makes it unique is that a second exposure to the polypeptide reverses the changes induced by first exposure.
64. Julius, MH, et al. A colostral protein that induces the growth and differentiation of resting B lymphocytes. Journal of Immunology 140:1366-1371 (1988). Colostrinin has also been shown to induce the growth and differentiation of resting B lymphocytes. T and B lymphocytes are the two main types of lymphocytes involved in the immune response.
65. Blach-Olszewska, Z, Janusz, M. Stimulatory effect of ovine colostrinine (a proline-rich polypeptide) on interferons and tumor necrosis factor product by murine resident peritoneal cells. Archivum Immunologiae et Therapie Experimentalis (Warsaw) 45(1):43-47 (1997). Colostrinin stimulates the production of tumor necrosis factor-alpha (TNF-?) and interferon-beta (INF-?), both important cytokines in the inflammatory response.
66. Hagiwara, K, et al. Oral administration of IL-1 beta enhanced the proliferation of lymphocytes and the O(2)(-) production of neutrophil in newborn calf. Veterinary Immunology and Immunopathology 81(1-2):59-69 (2001) Interleukin-1? in colostrum stimulates the immune system by increasing the amount of peripheral white blood cells, especially monocytes.
67. Bocci, V, et al. What is the role of cytokines in human colostrum? Journal of Biologic Regulatory and Homeostatic Agents 5(4):121-124 (1991). The cytokines present in colostrum, such as TNF-?, interferon-?, IL-1 and IL-6, have an immunostimulatory effect. This could be significant for aged people or others with immunodeficiency.
68. Bessler, H., et al. Human colostrum stimulates cytokine production. Biology of the Neonate 69(6):376-382 (1996). Colostrum has also been shown to stimulate the production of certain cytokines, IL-1, IL-3 and IL-6, in peripheral white blood cells (monocytes).
69. Bogdan, C, Nathan, C. Modulation of macrophage function by transforming growth factor beta, interleukin-4, and interleukin-10. Annals of the New York Academy of Science 685:713-739 (1993). Certain cytokines found in colostrum, TGF-?, IL-4 and IL-10, have a modulatory effect on macrophages, either stimulating or deactivating them as conditions dictate.
70. Gahr, M, et al. Influence of lactoferrin on the function of human polymorphonuclear leukocytes and monocytes. Journal of Leukocyte Biology 49(5):427-433 (1991). White blood cells (polymorphonuclear leucocytes) exposed to lactoferrin from bovine colostrum exhibit increased motility and produce more superoxide (a powerful antioxidant).
71. Sirota, L, et al. Effect of human colostrum on interleukin-2 production and natural killer cell activity. Archive of Diseases in Childhood: Fetal and Neonatal Edition 72(3):F99-102 (1995). Colostrum stimulates or inhibits the production of IL-2 depending on its concentration. It also inhibits the activity of natural killer cells, but the production of IL-2 reverses this effect. This is thought to be another way that colostrum modulates the immune system response.
72. Borody, TJ, et al. Tunnel vision in the bowel. Center for Digestive Diseases (2001). Review of irritable bowel syndrome, including ulcerative colitis and Crohn's disease, and its etiology, including infective agents such as Shigella and Campylobacter. Infections of the gut are difficult to treat because no antimicrobial therapy is available that is effective against Clostridia spores. Only bovine colostrum has proven clinical efficacy in eradicating intestinal pathogens, such as rotavirus, and may help control the infections seen in chronic disorders such as irritable bowel syndrome due to the number of biologically active components in colostrum. The growth factors in colostrum help heal intestinal erosions and ulcerations. It also contains anti-inflammatory factors and is nutrient rich. Colostrum may be used alone or in combination with other anti-inflammatory and/or immune substances. Future research should focus on identifying immune strategies, novel delivery systems and identification of the bioactives in colostrum.
73. Prosser, C, et al. Reduction in heat induced gastrointestinal hyperpermeability in rats by bovine colostrum and goat milk powders. Journal of Applied Physiology 96:650-654 (2004). Bovine colostrum healed "leaky gut" in an experimental rat model used heat induced gastrointestinal hyperpermeability.
74. Gastrointestinal Inflammation and Repair Group, Imperial College, London (2003). Unpublished research. In an in vitro experimental study, colostrum stimulated intestinal cell growth and reestablished a healthy epithelial layer following injury. In an in vivo experimental study, colostrum powder was also shown to reduce gastric injury.
75. Bitzan, MM, et al. Inhibition of Helicobacter pylori and Helicobacter mustelae binding to lipid receptors by bovine colostrum. Journal of Infectious Diseases 177:955-961 (1998). Bovine colostrum blocked binding of H. pylori (a major cause of chronic gastritis and ulcers in humans) and H. mustelae (a similar pathogen found in ferrets). This is apparently a function of the phosphatidylethanolamine found in colostrum and BIO-lipid.
76. Korhonen, H. Bactericidal effect of bovine normal and immune serum, colostrum and milk against Helicobacter pylori. Journal of Applied Bacteriology 78:655-662 (1995). The antibody-complement system found in bovine colostrum was also found to be bactericidal against H. pylori.
77. Carver, JD, Barness, LA. Trophic factors for the gastrointestinal tract. Clinical Perinatology 23(2):265-285 (1996). Factors in colostrum which promote the development of the GI tract in newborn infants also help protect against such diseases as Crohn's disease, colitis, necrotizing enterocolitis and diarrhea.
78. Bühler, C., et al. Small intestinal morphology in eight-day-old calves fed colostrum for different durations or only milk replacer and treated with long-R3-insulin-like growth factor I and growth hormone. Journal of Animal Science 76:758-765 (1998). The intestines of calves fed colostrum compared to those not fed colostrum revealed that those fed colostrum had significantly increased villus size and crypt depths. This translates into greater surface area and thus increased absorption of nutrients.
79. Blättler, U, et al. Feeding colostrum, its composition and feeding duration variably modify proliferation and morphology of the intestine and digestive enzyme activities of neonatal calves. Journal of Nutrition 131(4):1256-1263 (2001). A similar study done on calves either receiving or not receiving colostrum. This study concentrated on the development and health of the gastrointestinal epithelium and found that the development and health of this epithelium was markedly superior in those receiving colostrum. Colostrum also influenced the production of lipase enzyme by the pancreas.
80. Pluske, JR, Morel, PCH. Increasing weaner pig productivity in New Zealand pig herds. Unpublished research (1999). Piglets fed a liquid supplement with colostrum powder had a marked increase in villi height in the lumen of the small intestine, indicating greater digestion and absorption of nutrients. There were also an increased number of immune cells in the villi, indicating enhanced immune competency.
81. Playford, RJ, et al. Bovine colostrum is a health food supplement which prevents NSAID induced gut damage. Gut 44:653-658 (1999). Although non-steroidal anti-inflammatory drugs (NSAIDs) are very effective in controlling joint pain in arthritis, their use also causes significant, and sometimes fatal, gastrointestinal damage. Supplementation with colostrum, however, significantly reduced and healed injury caused by NSAIDs.
82. Playford, RJ, et al. Co-administration of the health food supplement, bovine colostrum, reduces the acute non-steroidal anti-inflammatory drug-induced increase in intestinal permeability. Clinical Science 100:627-633 (2001). Another study by Dr. Playford on the ability of colostrum to prevent damage due to NSAID use. This study showed that colostrum also prevents an increase in gastrointestinal permeability due to NSAID use, whereas NSAID use alone without colostrum causes an increase in permeability.
83. Goldman, AS, et al. Anti-inflammatory properties of human milk. Acta Paediatrica Scandinavica 75(5):689-695 (1986). The major anti-inflammatory components found in human milk (and bovine colostrum) include anti-proteases, lactoferrin, lysozyme, secretory IgA, and a number of antioxidants, including cysteine, ascorbate, alpha-tocopherol and beta-carotene.
84. Murphey, DK, Buescher, ES. Human colostrum has anti-inflammatory activity in a rat subcutaneous air pouch model of inflammation. Pediatric Research 34(2):208-212 (1993). In an experimental animal model using subcutaneous air pouches in rats, colostrum showed significant anti-inflammatory activity.
85. Buescher, ES, McWilliams-Koeppen, P. Soluble tumor necrosis factor-alpha (TNF-alpha) receptors in human colostrum and milk bind to TNF-alpha and neutralize TNF-alpha bioactivity. Pediatric Research 44(1):37-42 (1998). The ability of colostrum to modulate the inflammatory response is unique. One of the ways in which it does this is through TNF-? receptor proteins, which are found in colostrum. These bind to TNF-?, which inactivates the TNF-?. TNF-? is the activator of the entire inflammatory cascade, so by controlling its activity, colostrum controls the degree of the inflammatory response and can shut it off altogether.
86. Feldmann, M, et al. Role of cytokines in rheumatoid arthritis. Annual Review of Immunology 14:397-440 (1996). This study confirmed that TNF-? is the major controlling factor in the inflammatory response seen in rheumatoid arthritis. Therefore the ability of colostrum to modulate the activity of TNF-? may be the way in which colostrum is of benefit to those suffering from rheumatoid arthritis (and other types of arthritis as well).
87. Hagiwara, K, et al. Detection of cytokines in bovine colostrum. Veterinary Immunology and Immunopathology 76:183-190 (2000). Colostrum contains five cytokines, TNF-?, IL-1?, IL-6, IL-1ra (receptor antagonist) and INF-?, which have known immunomodulatory effects.
88. Feldmann, M, et al. Cytokines in autoimmune disorders. International Review of Immunology 17(1-4)217-228 (1998). Cytokines are important protein mediators of immunity, inflammation, cell proliferation, differentiation, fibrosis, and so forth, in other words, all the major biological processes which underlie autoimmune disorders. Modulating the effects of these cytokines, particularly TNF-?, can result in amelioration of the symptoms of the disorders.
89. De Keyser, F, et al. Gut inflammation and spondyloarthropathies. Current Rheumatology Reports 4(6):525-532 (2002). Spondyloarthropathies (SpA) are a related group of arthritic conditions which include ankylosing spondylitis, reactive arthritis, psoriatic arthritis and arthritis associated with inflammatory bowel disease. SpA have been correlated with gut inflammation and are immunologically related Crohn's disease. Colostrum's ability to control gut inflammation and modulate the activity of TNF-? indicate that it may be of benefit in SpA treatment.
90. Nitsch, A, Nitsch, FP. Clinical use of bovine colostrum. Journal of Orthomolecular Medicine 13(2) (1998). A colostrum preparation was used clinically to treat rheumatoid arthritis and osteoarthritis with good results.
91. Britigan, BE, et al. The role of lactoferrin as an anti-inflammatory molecule. Advances in Experimental Medicine and Biology 357:143-156 (1994). While the role of lactoferrin in providing non-specific immunity is well documented, it also plays a role in the anti-inflammatory response through its antioxidant effect.
92. Conneely, OM. Anti-inflammatory activities of lactoferrin. Journal of the American College of Nutrition 20(Suppl. 5):389S-395S (2001). Lactoferrin inhibits dermal inflammatory cytokine production and acts as a potent anti-inflammatory protein at local sites of inflammation, including the respiratory and gastrointestinal tracts.
93. Stanton, G, et al. Use of colostrinin, constituent peptides thereof, and analogs thereof, as oxidative stress regulators. US Patent #6,500,798 (2002). Colostrinin acts as a general purpose oxidative stress regulator. It can be used to reduce the effects of oxidative stress (i.e. free radicals) either locally, such as on the skin, or as a supplement for the entire body.
94. Collins, AM, et al. Bovine milk, including pasteurized milk, contains antibodies directed against allergens of clinical importance to man. International Archives of Allergy and Applied Immunology 96:362-367 (1991). The presence of antibodies against many of the most common allergies in man, including ryegrass pollen, house dust mites, Aspergillus mold and wheat gluten, were detected in bovine colostrum.
95. Delespesse, G. Polypeptide factors from colostrum. US Patent #5,371,073 (1994). IgE (the immunoglobulin involved in allergic response) binding factors (IgE-bf) and IgE suppressor activity (IgE-SF) obtained from colostrum have been successfully used to treat allergies.
96. Leszek, J, et al. Colostrinin^®: a proline-rich polypeptide (PRP) complex isolated from ovine colostrum for treatment of Alzheimer's disease. A double-blind, placebo-controlled study. Archivum Immunologiae et Therapiae Experimentalis 47:377-385 (1999). Colostrinin has psycho-immuno-enhancing activity. It was given to patients with Alzheimer's disease and mild to moderate dementia and compared to placebo and selenium, another putative natural treatment for Alzheimer's. Colostrinin demonstrated stabilization of symptoms in 13 of 15 patients as compared to none in the selenium group.
97. Leszek, J, et al. Colostrinin^® proline-rich polypeptide complex from ovine colostrum - a long-term study of its efficacy in Alzheimer's disease. Medical Science Monitor 8(10):P193-P196 (2002). In a longer-term study, colostrinin produced improvement or stabilization in patients involved in the study.
98. Amaducci, L, et al. Use of phosphatidylserine in Alzheimer's disease. Annals of the New York Academy of Science 640:245-249 (1991). Supplementation with phosphatidylserine, one of the phospholipids found in BIO-lipid, also produces an improvement in symptoms in Alzheimer's.
99. Crook, TH, et al. Effects of phosphatidylserine in age-associated memory impairment. Neurology 41(5):644-649 (1991). Patients with age-associated memory impairment showed significant improvement in memory performance tests with phosphatidylserine supplementation over a 12 week period.

1Crook, T, et al. Effects of phosphatidylserine in Alzheimer's disease. Psychopharmacology Bulletin 28(1):61-66 (1992). Another study which showed an improvement in symptoms of Alzheimer's with phosphatidylserine supplementation over 12 weeks. The less the impairment, the greater the improvement, suggesting that the earlier phosphatidylserine supplementation is begun in the course of the disease, the better the results will be.

1. Cross, CE, et al. Oxygen radicals and human disease. Annals of Internal Medicine 107(4):526-545 (1987). Oxygen free radicals, the by-products of normal metabolism, have been implicated in disease processes ranging from carcinogenesis to aging, emphasizing the importance of antioxidants in combating these conditions.
2. Ames, BN, et al. Oxidants, antioxidants, and the degenerative diseases of aging. Proceedings of the National Academy of Sciences USA 90(17):7915-7922 (1993). Oxidant by-products of metabolism cause significant damage to DNA, proteins and lipids. This damage results in aging and the degenerative diseases associated with aging, such as cancer, cardiovascular disease, immune system decline, brain dysfunction and cataracts. Antioxidant defenses against these diseases decline with age, necessitating the supplementation of antioxidants in the diet.
3. Shigenaga, MK, et al. Oxidative damage and mitochondrial decay in aging. Proceedings of the National Academy of Sciences USA 91(23):10771-10778 (1994). The major source of oxidative damage are oxidants generated by mitochondria in the cells of the body. Mitochondrial function declines with age, including decreased membrane fluidity, proton leakage across the inner mitochondrial membrane, and decreases levels of cardiolipin, an important lipid which supports the functioning of proteins in the inner mitochondrial membrane.
4. Kurz, DJ, et al. Chronic oxidative stress compromises telomere integrity and accelerates the onset of senescence in human endothelial cells. Journal of Cell Science 117:2417-2426 (2004). Oxidative stress due to the buildup of oxidization by-products has been linked to the onset of cell senescence in blood vessel lining cells by disrupting telomere integrity. Telomeres are the "tails" of the chromosomes, the length of which determine the number of cell divisions a cell can undergo before reaching its limit. Glutathione, a powerful natural antioxidant, is crucial in maintaining telomere integrity.
5. Borissenko, M. Glutathione: A powerful anti-oxidant found in colostrum. NZMP August 2002. Both glutathione and its chemical predecessors are present in large quantities in colostrum. As glutathione is not absorbed directly, glutathione production in the body can only be accomplished by supplementation with its antecedents, cystine, glycine and glutamic acid, all of which are abundant in colostrum.
6. Buescher, ES, McIlheran, SM. Antioxidant properties of human colostrum. Pediatric Research 24(1):14-19 (1988). Colostrum reduces ferricytochrome C in polymorphonuclear leucocytes (PMNs) and also disrupts other metabolic and enzymatic activities of PMNs which are crucial in PMN respiratory burst mediation of acute inflammation, showing that colostrum is a powerful antioxidant.
7. Buescher, ES, McIlheran, SM. Colostral antioxidants: separation and characterization of two activities in human colostrum. Journal of Pediatric Gastroenterology and Nutrition 14(1):47-56 (1992). Colostrum interferes with the production of PMN respiratory burst products in two ways, ascorbate and uric acid.
8. Boldogh, I, et al. Modulation of 4HNE-mediated signaling by proline-rich peptides from ovine colostrum. Journal of Molecular Neuroscience 20(2):125-134 (2003). Colostrinin down regulates lipid peroxidation, inhibits glutathione depletion and reduces intracellular levels of reactive oxygen species (ROS). This is one more way that colostrum demonstrates antioxidant activity.
9. Wakabayashi, H, et al. Inhibition of iron/ascorbate-induced lipid peroxidation by an N-terminal peptide of bovine lactoferrin and its acylated derivatives. Bioscience, Biotechnology, Biochemistry 63(5):955-957 (1999). Lactoferrin also plays an important antioxidant role in colostrum by preventing lipid peroxidation.

 

RECEPTOL® in Disaster Relief

By PROF. RALPH FOSTER, M.D., M.P.H.

Our public health community is in an enviable position today of having the ability to provide biotech products and services to prevent and reduce infectious disease as major health concerns for the Tsunami survivors.

Globalceuticals, Inc. is committed to bringing the discovery of informational proteins into the public domain in the form of RECEPTOL^®; a biotech product that reorients the system of the body to support wellness, by normalizing mammal cellular function, provides stoichometric hindrance to viruses at the cellular surface to prevent viruses attaching to cell surfaces, and when needed induce recovery. 

Recently, the SARS virus was a high profile disease in China.  SARS is a virus, like many other viruses can be treated successfully with RECEPTOL.  The RECEPTOL^® software includes an uncounted number of ligand protein units all designed to key into cellular receptor sites and block viruses from attaching to human cells.  Exploration of new health possibilities becomes essential to making a difference in the quality of people's lives.

To date RECEPTOL^® (infopeptide supplementation) is indicated for the prevention and reduction of: Tuberculosis, Acute and chronic viral infections (HAV, HCV, HIV, SARS, Mononucleosis, Colds, Flus, and Rabies), Allergies, Thrush, Viral and Bacterial Pharyngitis, Celiac Sprue, Kuru (Prion Disease), topical applications (burns, infections, and insect bites). The world needs a more effective method of response to life threatening infectious diseases that is:

• Broadly effective with ancillary effect against a wide range of opportunistic infections
• Safe under all circumstances including extended use
• Without the prospect for eventual resistance
• Practical, palatable and easy to administer
• Compatible with other treatments
• Compatible with religious and cultural sensitivities
• Universally available
• Priced appropriately in all markets
• Available to the poor with assistance from non-profit organizations

Ralph Foster, a professor of health sciences at the University of Phoenix, has 25+ years experience in immunological research, as well as in NIAID, NIH Conference presentations.  He has had international, hands on experience in medicine, and public health.  He is currently located in San Miguel, California. 

 

COPYRIGHT ã 2004, Prof. Ralph Foster, M.D., M.P.H.  All Rights Reserved.

RECEPTOL® EFFICACY TEST REPORT

1. RECEPTOL’S® Mode of Action

RECEPTOL’S® Info-protein matrix works:

1. The small molecular weight proteins called peptides act as attachment inhibitors, by docking on the CD4 GP-120 receptor site preventing the attachment of HIV.
   
2. Once docked on CD4 GP-120 receptor site, it sends a signal telling the other CD4 T- cells to “lock-down” and not allow HIV to attach.
   
3. In the first 30-60 days the viral load may increase, because it cannot attach.
   
4. CD4 T-cells will also begin to increase in the first 30-60 days.
   
5. The viral load will begin to decrease significantly from 60 days on, and go undetected in 180-210 days.
   

2. Intra-Oral Absorption

The reason Intra-Oral is so fast, is the flow of absorbed nutrients from this area of the mouth is to the Carotid Artery, this is the large artery that supplies blood to the brain and the heart. Absorption through this method supplies nutrients to the brain and the heart within 22 to 30 seconds! Within minutes, it is totally dispersed throughout the body.

The Absorption Effectiveness Chart on this page is based on the authoritative Physician's Desk Reference Manual and clearly illustrates the difference in absorption by various means. Oral Absorption through the mucosa (the lining of the mouth) is the preferred choice of medical experts, and provides up to 9-times more effective absorption into the bloodstream... within just seconds.

Oral absorption is the preferred choice of medical experts for the administration of nutrients and drugs over the orally swallowed tablet or pill, thus avoiding the gastrointestinal tract and its many limitation." - Introduction to Pharmaceutical Dosage Forms (Howard C. Ansel, Ph.D., Second Edition, 1976).

"When DHEA is swallowed in a capsule, it first must pass through the liver before it can reach the body. The liver may metabolize up to 90% of the DHEA before it reaches the rest of the body. By opening the capsule, and holding the powder under your tongue before swallowing, you will get rapid absorption into your brain where it can produce neurological protection and enhancement."

- Life Extension Foundation Newsletter, July 1996.

"... asthmatics who use inhaled steroids are half as likely to be hospitalized as those who use other (forms of) - or no - medication." - 16,941 HMO enrollee study published in JAMA.

3. Evidence of Non-recurrence of HIV after the treatment is stopped.

Phase 3 – HIV trial

In November 2002, Phase 3 of the study on HIV began in Rwanda. The protocol was similar to that which was employed in Phase 1 and Phase 2.

Objectives: To demonstrate, under clinical conditions, the safety and efficacy of infoprotein supplementation in patients known to have advanced disease (HIV/AIDS). Cohorts were all symptomatic, ambulatory, compliant and native to anti-retroviral therapy.

Limitations: The transient nature of the cohort population and minimal control of product use.

Population: 60 cohorts, term: 365 days and moderate control of product use.

Considerations: All cohorts receive oral supplementation of RECEPTOL® every 6 hours for a period of 365 days.

25

Some patients could not refrigerate the product after opening, therefore exposing it to the denaturing effect of bacterial contamination.

The patients were not made aware of the positive potential of the product.

Results:· The product appeared to be free of side effects and generally well tolerated by the participants. Some signs, consistent with detoxification, were noted but resolved when the patients increased their water consumption.

• The product demonstrated significant value by reducing or resolving the symptoms of opportunistic infections most commonly associated with the dynamic of HIV/AIDS.
  
  
• Patients often experienced weight gains as part of an overall pattern of positive response.
  
  
• After 1 day of use there was a moderate level of relief of fever and diarrhea.
  
  
• After 14 days of use all patients experienced relief of skin lesions, mouth thrush, fever, diarrhea, tuberculosis.
  
  
• After 90 days of use all patients experienced relief of all symptoms.
  
  
• After 330 days all patients are still not experiencing any negative symptoms.
  

Discussion:

In brief, the patients recovered very quickly but complain of INTENSE HUNGER AND THIRST. It is VITAL TO INTERVENE BY GIVING PROTEIN SUPPLIMENTATION to be able to observe the body reconstruction as most patients are very poor and have low protein intake. Generally speaking there is an excellent recovery for all patients that have been on the product but the EXTREME HUNGER is hindering the weight gain process. – Dr. Rusibira, Internal Medicine Specialist.

Summary:

Positive clinical results are continually observed in the Rwanda patients.

4. Control: Positive & Negative

All subjects were given the RECEPTOL® in the East African study. There wasn’t a control group given a placebo or another HIV/AIDS drug. There were no side effects reported other then increase appetite, energy and hopefulness.

5. Can a healthy person take it as a prophylaxis, prevention for HIV?

At this time we are uncertain that RECEPTOL® can be used as a prophylaxis for HIV. Theoretically, because of the mode of operation, one can surmise that it may very well work as an effective prophylaxis. We would entertain the idea of further clinical trials to find the answer.

RECEPTOL® - Immune Booster

I began taking RECEPTOL® almost a year ago as a preventative, because my kids kept bringing home colds and flu, which I would repeatedly get every year. Since I have been on the product, I did not catch either, while everyone else around me got sick.

Tony A. – Former Pro Athlete, Lake Tahoe , CA

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I have been HIV positive for over 20 years and on AZT medication, which causes the destruction of red blood cells as a side effect. I began using RECEPTOL® in late August 2004 after my last doctor visit. In October, I went for my usual two-month check-up and found that my red blood cell count was normal for the first time in years. My HIV viral load had decreased from 60,000 to 6,800, which shows significant improvement in my white blood cell count. Next doctors visit is in January.

David S. – Consultant, New York

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A fungus infection has plagued my large toe for several years. Within a month, not only has the fungus diminished, but the toenail is actually growing back. Thank you, RECEPTOL®.

Michelle P. – Therapist, Sweden

see also: • RECEPTOL home page

 

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see also: RECEPTOL and Allergies

 

RECEPTOL® and Medical Nano-Peptides (NPs) FAQs:

• What is RECEPTOL?
• What is Nanotechnology?
• How is RECEPTOL administered?
• How does RECEPTOL work?
• So, is RECEPTOL a cure?
• What is the mode of action?
• What are the practical applications for MNP supplementation?
• How does the body use the MNPs?
• So, RECEPTOL also works for animals?
• How long does someone have to take RECEPTOL?
• Is RECEPTOL a drug?
• Does it have any side effects?

Q: What is RECEPTOL®?

A: RECEPTOL® is an oral spray derived from first milking colostrum, offering the safest and most advanced support for the immune system today.

RECEPTOL® is NOT COLOSTRUM, although it is derived from it. It is a specialized concentration of Medical Nano-Peptides (MNPs) that have been carefully separated using advanced biotechnology.

Q: What is Nanotechnology?

A: Nanotechnology is the science of the small. Nano is Greek for dwarf, and nanoscience deals with the study of molecular and atomic particles, a world that is measured in nanometers (billionths of a meter or 10-9).

Medical Nano-Peptides (MNPs)

According to researchers, Medical Nano-Peptides (MNPs) are small enough that hundreds of them could fit on the surface of a biological cell. MNPs can patrol your body; armed with knowledge and the ability to communicate what is friendly and what is foreign to your immune system, they can repel any foreign invaders by attaching themselves to specific receptor sites on the surface of the cell. Because they fill those receptor sites, foreign adverse invaders are blocked from entry. Imagine, the common cold or flu may no longer be a problem with RECEPTOL® on guard.

Q: How is RECEPTOL® administered?

A: RECEPTOL® comes in a 4.25 ounce pump-spray bottle. It is generally sprayed onto the inner cheek wall an average of three sprays two to three times per day (21 milliliters). It is advised to hold the liquid in the mouth without swallowing for at least 60 seconds or so. There are a few other recommendations depending on what the specific health challenge is.

Q: How does RECEPTOL® work?

A: By spraying RECEPTOL® on the inner cheek, Medical Nano-Peptides (1-billionth or 0.000 000 001 of a meter in size) are delivered through the mucosal membrane directly into the blood stream within seconds.

In both clinical and field observations, our theory proposes that these MNPs attach to the receptor site on T-cells imparting instruction to the immune system to reorient or correct its response strategy against autoimmune disease. This process induces anti-inflammatory cytokine-type activity by the body. In other words, we believe these MNPs essentially reboot the immune system, so the cell’s original immune response is restored. Further studies are in progress and planned in the future.

Q: So, is RECEPTOL® a cure?

A: We cannot use the term “cure.” The FDA prohibits such claims. However, we must understand that only the body can cure itself. A myriad of biological variances and the attendant responses of human beings determine whether a person can employ the effective use of whatever may be introduced into an individual’s system. The FDA even prohibits drug companies from touting that they have a cure for any condition. In actuality, most of the time drugs interfere with the wisdom of the body to repair and heal. All drugs have “side effects,” a term which is more medically acceptable than saying it is harmful. If the appropriate resource is available, the body knows what to do with it. In clinical situations with the use of RECEPTOL®, and depending on the challenge, the body can sometimes recover in a relatively short period of time.

Q: What is the mode of action?

A: We believe MNPs impart information analogous to downloading computer software. This information acts as an "operating system" directing and contributing to the cells ability to respond to pathogens while rebooting the immune system to recognize foreign versus friendly. We believe this type of information is what nature intended to deliver to the cells of infants through colostrum from the first few days of breast feeding prior to the digestive process being initiated and becoming fully functional. In RECEPTOL®, these MNPs are concentrated. (In Candace Pert's book "Molecules of Emotion", she traces her scientific journey by documenting the existence of what appears to be information carrying peptides to receptor sites throughout the body. We believe the MNPs in RECEPTOL® are consistent with her scientific findings).

Q: What are the practical applications for MNP supplementation?

A: At this time, we are conducting Phase 3 Clinical Trials in Bombay, India with the full support of the Indian Government. We are in the process of registering RECEPTOL® as a pharmaceutical drug and filing a medical use patent for HIV/AIDS in India as well. Currently, we have several cases in which RECEPTOL® proves effective for Hepatitis C (HCV). RECEPTOL® also seems to be effective for the common cold, flu, herpes, fungus, chronic fatigue, fibromyalgia, shingles, and for topical use on the skin as well as for the health of the gums.

Q: How does the body use the MNPs?

A: The MNPs are typically absorbed through the oral mucosa and are not utilized through the digestive tract. They may also be absorbed directly by cells through open tissue injuries including surgery, burns and some lesions.

Q: So, RECEPTOL® also works for animals?

A: It has been effective with species other than humans. Oral spray is easier to administer than pills. An excellent application is for the gums in animals since brushing is challenging for most.

Q: How long does someone have to take RECEPTOL®?

A: Because the variety of conditions RECEPTOL® is used for, it is difficult to determine exact timeframes. There have been cases where people have taken it for as short a duration as two weeks and have had no reoccurrence of symptoms. About 40% of the time, there is no reoccurrence of symptoms for as long as a year. About 60% of the time there can be a reoccurrence of symptoms within four to six months or so after only using RECEPTOL® for 15 to 30 days. In severe situations, it would be advisable to continue use for up to 2 years even if symptoms have disappeared.

Q: Is RECEPTOL® a drug?

A: RECEPTOL® is currently classified as a dietary supplement in the United States, but is being classified and registered as a drug in India.

Q: Does RECEPTOL® have any side effects?

A: No! There are no known side effects or contraindications. It is safe to take with anything else and is not effected by any other substance that we know of.

see also:

• RECEPTOL home page
• RECEPTOL and Allergies 

see also: • RECEPTOL home page