Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Using a micro-organism to make a protein or polypeptide
Reexamination Certificate
1998-12-11
2004-07-20
Minnifield, Nita (Department: 1645)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Using a micro-organism to make a protein or polypeptide
C435S325000, C424S184100, C424S265100, C424S520000, C530S350000, C530S412000, C530S855000
Reexamination Certificate
active
06764838
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the prevention and/or treatment of a condition or disease state in an individual which results from an excessive immune response.
BACKGROUND OF THE INVENTION
Parasites are living entities that dwell on or in other creatures during some part of their life cycles, drawing nourishment from the host. Parasites that inhabit the intestines have a complex interplay with the mucosal immune system. They must establish a tranquil relationship with host mucosal defenses to survive.
Helminths are elaborate multicellular worms with complex life cycles and development. The nematodes (non-segmented roundworms) and the platyhelminths (flatworms) are the two groups of helminths that colonize the human intestines. Perhaps more than a third of the population of the world currently shelter one or more of these organisms. The lifetime exposure rate, however, is actually much more. The prevalence of helminths is highest in warm climates and in populations subject to crowding, poor sanitation and impure food supply. Inflammatory bowel disease (IBD), rheumatoid arthritis and autoimmune diseases are rare in these same regions.
Nematodes that frequently inhabit the human gut are
Ascaris lumbricoides, Enterobius vermicularis
(pin worm),
Trichuris trichiura
(whipworm),
Ancylostoma duodenale
and
Necator americanus
(hookworms), and
Strongyloides stercoralis. Trichinella spiralis
infests the small intestine briefly.
The platyhelminths include the trematodes and cestodes. The most common adult trematodes that reside in the human intestines are Fasciolopsis, Echinostoma and Heterophyes species. Those that live in the biliary system include
Clonorchis sinensis, Opisthorchis viverrini
and
felineus
, and
Fasciola hepatica
. Schistosoma dwell in the venous system, but several species chronically affect the gut by the passage of eggs through the intestinal wall. Adult cestodes commonly infecting humans are Diphyllobothrium species (fish tapeworm),
Taenia saginata
(beef tapeworm),
Taenia solium
(pork tapeworm) and
Hymenolepsis nana
(dwarf tapeworm).
The host acquires various helminthic species through contact with soil, food or water contaminated with the infective form of the parasite. Children most frequently harbor helminthic infections because of their close contact with soil and suboptimal hygienic practices. Helminths incite an intestinal Th2 response, which can cause worm expulsion or limit the magnitude of infection. Most children living in non-industrialized countries have these parasites. Many helminthic species survive for years within the gut, biliary tree or mesenteric veins making thousands of eggs daily. Thus, beginning in childhood, these worms and/or their ova release molecules that bathe the intestinal mucosal surface for years inciting Th2-type inflammation. Dysregulation of the immune system leading to an excessive Th1 response may be the cause of several human diseases. Some diseases due to dominant Th1 responses include IBD, rheumatoid arthritis, sarcoidosis, multiple sclerosis, and insulin-dependent diabetes melitis.
IBD is more common in temperate climates. It is not known what causes the geographic differences. Observations suggest an environmental exposure unique to temperate countries and highly industrialized societies predisposes to the development of IBD. An alternative explanation is that it is unhealthy to be raised in an “over clean” environment. It is proposed herein that the major environmental factor predisposing to IBD is underexposure during childhood to intestinal helminths, which promote strong Th2-type inflammation.
The frequency of CD has increased substantially over the last 40 years. It is most prevalent in temperate regions that are highly industrialized. This suggests that there is some critical environmental factor responsible for the change in frequency. Also, ulcerative colitis is rare in underdeveloped countries. It is proposed according to the invention that the absence of exposure to intestinal helminthic infections in childhood is an important environmental factor favoring the development of CD and perhaps ulcerative colitis (UC).
People in industrialized countries are living in increasingly hygienic environments and are acquiring helminths much less frequently. The decreasing frequency of helminthic infections appears to correlated with the increasing prevalence of CD. A case in point is the marked increase in the frequency of CD in young Asians and Africans after residing in Israel for greater than 10 years. Also, the frequency of helminthic infestation differs between the Jewish Israelis and Arabs. In 1969, stool examinations of hospitalized patients in Arab-predominant East Jerusalem contained helminthic ova over 60% of the time. The frequency in Israeli-predominant East Jerusalem was 10% or less.
Thus, It is possible that the failure to acquire helminths and to experience mucosal Th2 conditioning predisposes to CD and UC. There is a need to combat CD and UC by re-colonization of the gastrointestinal tract with these organisms which may afford protection.
One object of the invention is to prevent or treat an excessive immune response in an individual. The excessive or aberrant immune response can be caused by an autoimmune disease, for example, IBD, rheumatoid arthritis, type 1 diabetes melitis, lupus erythematosis, sarcoidosis and multiple sclerosis.
Further, it is an object of the instant invention to provide a method of vaccinating an individual against autoimmune disease, for example, IBD, rheumatoid arthritis, type 1 diabetes melitis, lupus erythematosis, sarcoidosis and multiple sclerosis.
It is an object of the present invention to provide a method of creating an immune environment in an individual that is conducive to ameliorating IBD.
It is an object of the present invention to provide a pharmaceutical composition comprising a helminthic parasite and a pharmaceutically acceptable carrier.
It is a further object of the present invention to provide a pathogen-free helminthic parasite and an acceptable pharmaceutical carrier.
It is another object of the present invention to provide a method of preparing pathogen-free helminthic parasites.
SUMMARY OF THE INVENTION
The instant invention presents a method of preventing or treating an excessive immune response in an individual by administering an effective amount of an helminthic parasite preparation to reduce the excessive immune response in the individual.
The invention encompasses a method of treating an excessive immune response, including an aberrant/enhanced Th1 response, comprising administering a helminthic parasite preparation in an amount sufficient to reduce the excessive immune response.
As used herein, the term “helminth parasite preparation” refers to any one of a whole parasite, a parasite extract, parasite eggs, parasite egg extract, parasite larvae, parasite larvae extract, parasite cercariae and parasite cercariae extract.
The helminthic preparation may be selected from the group consisting of helminiths that naturally colonize humans and helminths that colonize animals but may protect humans from an excessive Th1 response.
In other preferred embodiments of the invention, the helminth parasite is a nematode, and may be selected from the group such as
Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale
and
Necator americanus, Strongyloides stercoralis
and
Trichinella spiralis.
In other preferred embodiments of the invention, the helminthic parasite is a platyhelminth, and may be selected from the group consisting of trematodes and cestodes, such as Fasciolopsis, Echinostoma and Heterophyes species,
Clonorchis sinensis, Opisthorchis viverrini, Opisthorchis felineus, Fasciola hepatica
, Schistosoma species, Diphyllobothrium species,
Taenia saginata, Taenia solium
and
Hymenolepsis nana.
In other preferred embodiments, the helminthic parasite is selected from the group consisting of filarial parasites and lung flukes.
In additional embodiments, the helminthic parasites are sele
Elliott David E.
Weinstock Joel V.
Minnifield Nita
Palmer & Dodge LLP
University of Iowa Research Foundation
Williams Kathleen M.
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