RECEPTOL and Allergies

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.