GB2304048A - Medicament containing saliva extract - Google Patents

Abstract

A medical composition comprises a salivary extract, preferably from an insect, more preferably from midges (Ceratopogonidae) or mosquitoes (Anopheles, Aedes,Culicidae). It is expected that the pharmacological effect is mediated by proteolytic enzymes present in the saliva. The composition may be applied topically, orally or parentally and is intended for the treatment of viral infections, particularly HIV. The composition may be a water-based cream or oil-in-water emulsion and is preferably used in the form of a barrier coating.

Description

PREVENTION AND/OR TREATMENT OF DISEASE This invention relates to compositions and methods for the treatment or prevention of disease in humans and animals.

There is general concern that viral, microbial, bacterial, cancer and protozoan diseases are on the increase. Of particular concern are infections such as encephalitis, HIV, malaria, trapanosomiasis, ameobiasis, haemorrhagic fever, ebola, tuberculosis, brucellosis, systic lupus, erythematosus, Crohn's disease, meningitis, dengue, yellow fever, filariasis, Rift Valley fever, skin cancer, hepatitis, swamp fever, typhoid.

Considerable research effort has been and is currently focused on the identification of curative treatments for viral, microbial, bacterial, cancer and protozoan diseases. While some advanced drugs have been found to be effective against several specific infections, only limited progress has been made against the broad spectrum of such diseases.

In many cases the development of recognisable symptoms of viral, microbial, bacterial, cancer and protozoan diseases occur long after the infection and are indicative of advanced stages of infection. At such advanced stages these diseases may be untreatable and are frequently terminal.

Most of the above listed infections are caused by penetration of a human epidermal or mucosal surface by infective agents, for example by virus, microbe, bacteria or protozoa. Many tropical diseases, for example, are caused by penetration of the skin by insects such as mosquitoes, e.g. Anopheles or Aedes, or Ceratopogonidae family i.e. midges. Such penetrations by insects carry infective agents into the lymphatic or blood systems of humans, causing many of the above listed diseases.

It has been observed that specific insects and even specific genera within families of insects1 transmit specific diseases to man and/or animals. Conversely, it has been realised that some genera within these same families of insects exhibit refractoriness towards infective agents. This is to say that specific genera within these families of insects possess chemical mechanisms that kill, nullify or inactivate specific infective agents.

It has further been observed that these specific genera of insects that exhibit specific refractoriness penetrate human and/or animal skin with their proboscis, which is lubricated, moistened, wetted or filled with saliva. This saliva contains enzymes to initiate predigestion of the insect's chosen food, which may, for example, be human blood.

It is believed that the saliva of specific insects which exhibit specific refractoriness towards specific human and/or animal diseases contains chemically active ingredients that kill, nullify or inactivate specific infective agents, for example viruses, microbes, bacteria and/or protozoa.

In accordance with a first aspect of the invention, there is provided a composition for the pharmacological treatment of a human or animal, containing one or more active ingredient(s) based on, extracted from or replicating the saliva of a saliva-producing organism.

The composition may be for curative use, to halt the onset of an infection already present, or more preferably, may be for preventive or prophylactic use.

The saliva-producing organism may, for example, be an invertebrate, reptile, amphibian or mammal. Preferably, however, the organism is an insect. Most preferably it is an insect of the family Ceratopogonidae (midges) or, especially, of the family Culicidae (mosquitos).

In accordance with a second aspect of the invention there is provided a method of pharmacological treatment of a human or animal, comprising administering an effective amount of a composition containing one or more active ingredient(s) based on, extracted from or replicating the saliva of a saliva-producing organism.

Preferably, the composition and method are for the treatment of humans.

The composition may be administered to the human or animal in any way, for example orally, parenterally or, preferably, by external application. Preferably it is applied to an epidermal or mucosal surface, for example, rectally, sublingually or by application to skin. It is expected that the composition will provide a prophylactic effect by preventing or inhibiting the penetration of a mucosal or epidermal surface, by an infective agent. The nature of the infective agent may determine the mode of application. For example, when the composition is for the prevention of infection by the HIV virus as a result of sexual contact it may be applied as an oil or cream, for example to genital regions. Alternatively or additionally it may be comprised in a formulation comprising a lubricating oil or a spermicidal cream.

The composition may be comprised in a formulation with a sun-screening agent and/or a moisturizer, and/or an insect repellent, and/or a scent. When the infective agent is known to be able to penetrate the body at any skin site the composition may be applied to substantially the entire skin of the patient. This may be achieved by means of an all-over body cream, or by application by means of an aqueous shower or bath containing the active ingredient(s), as will be described further.

In accordance with a third aspect the present invention comprises a method and composition for preventing infection, by means of a coating externally applied to the body. Such a coating may be applied to any part of the skin of a human. It may be applied to a region only, for example the genital region, but is preferably applied over substantially the entire skin of a human.

The invention and all its aspects is of particular interest in relation to the prevention or treatment of infection by the HIV virus.

It is believed that the saliva of specific general of specific insect families contains combinations of specific proteolytic enzymes, possibly together with specific secretory leucocyte protease inhibitors and specific proteins such as mucins that kill, nullify or inactivate specific viruses, microbes, bacteria or protozoa.

It is also believed that the saliva of specific genera of invertebrates such as leeches and reptiles such as snakes and amphibians such as frogs and mammals such as cows, horses and humans also contain proteolytic enzymes plus secretory leucocyte protease inhibitors and mucins; and that such saliva combinations may also kill, nullify or inactivate specific infective agents.

The mechanism by which such salivas may kill, nullify or inactivate specific infective agents is believed to be that the secretory leucocyte protease inhibitor(s) -can modify the activity of the proteolytic enzyme so that it can only key onto specific linkages in specific protein chains. These specific linkages characterise the protein chain of the infective virus, microbe, bacteria, or protozoa. Once attached to these specific protein linkages the proteolytic enzyme breaks the chain in the protein at that point. This chain breakage kills, nullifies or inactivates the infective agent. The role of the mucins may be to entrap the broken-off protein chain, thereby preventing re-formation of the infective agent.

However, the mechanism by which the different aspects of the invention may work is not limiting to those aspects.

The coating as described above may contain active ingredients composed of saliva, salival extracts, or derived or replicated or synthesised proteolytic enzyme(s), optionally with secretory leucocyte protease inhibitor(s), and optionally with mucin(s). The source of such salivas or saliva extracts or saliva replicants may be specific insects, invertebrates, reptiles, amphibians or mammals.

The active agent(s) in the saliva(s) may be isolated, validated by testing against target organisms, analysed and then synthesized, using the techniques of physical, analytical and organic chemistry, and following biological testing. Furthermore, the gene(s) responsible for the active agent(s) may be identified. Molecular biology offers the possibility of providing the gene(s) in organisms, to produce for example transgenic sheep or cattle, able to produce much larger quantities of saliva containing the active ingredient(s).

Specific embodiments of the invention will now be described by way of example.

A barrier coating designed for use as a preventative measure against tropical diseases such as dengue, yellow fever, Rift Valley fever, swamp fever and typhoid, is based on blended or replicated salival extracts from the Mosquito generas Aedes, Culex and Mansonia. The salival extracts or replicants is believed to contain specific proteolytic enzymes plus specific secretory leucocyte protease inhibitors plus specific mucins, and can kill, nullify or inactivate the target infective agents. The salival extract or replicant is made up into an oil/water emulsion based on cyclomethicone, ethyl hexyl stearate, lauryl octoate, cetyl palmitate, glycerine, carnuba wax, sodium citrate and water. The barrier coating is contained in a cartridge which is loaded into a venturi valve of a shower unit so as to coat the whole body.At the end of the shower the venturi may be operated to apply the protective material which is allowed to dry. To assist this a hot air blower may be provided.

A barrier coating may be designed for use as a preventative measure against HIV infection in the event of possible contact with infected body fluids e.g. in invasive operations or other invasive clinical procedures.

This barrier coating is based on blended or replicated salival extracts from the Mosquito genera Anopheles. The salival extract or replicant is made up into a wax/oil suspension based on jojoba oil, carnuba wax, sodium lactate, lanolin and lecithin. This barrier coating is contained in conventional bottles for pouring onto the surface of a warm water bath, so as to coat the whole body.

A barrier coating may be designed for use as a preventative measure against skin cancers. This barrier coating is based on blended or replicated salival extracts from cows. The salival extract or replicant is made up into a water based cream based on glycerine, macadamia oil, coconut oil, sub-micron zinc oxide and water. This barrier coating is contained in tubes for application to all exposed parts of the body e.g. when working outside or sunbathing.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

The invention further relates to any novel idea or combination of ideas disclosed herein.

Claims (7)

1. A composition for the pharmacological treatment of a human or animal, containing one or more active ingredient(s) based on, extracted from or replicating the saliva of a saliva-producing organism.

2. A composition as claimed in Claim 1, wherein the saliva-producing organism is an invertebrate, reptile, amphibian or mammal.

3. A composition as claimed in Claim 2, wherein the organism is an insect.

4. A composition as claimed in Claim 3, wherein the organism is an insect of the family Ceratopogonidae (midges) or of the family Culicidae (mosquitos).

5. A composition as claimed in any preceding claim, adapted for external application to a mucosal or epidermal surface of a patient.

6. A composition as claimed in any preceding claim, for the treatment of a human or animal body against the HIV virus.

7. A composition substantially as hereinbefore described with reference to the accompanying description.