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Therapeutic agent for ulcerative colitisRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, In Vivo Diagnosis Or In Vivo Testing, Testing Efficacy Or Toxicity Of A Compound Or Composition (e.g., Drug, Vaccine, Etc.)Therapeutic agent for ulcerative colitis description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060083686, Therapeutic agent for ulcerative colitis. Brief Patent Description - Full Patent Description - Patent Application Claims
BACKGROUND OF THE INVENTION [0001] The present invention relates to a drug for treating a patient with ulcerative colitis, which is one of the intractable diseases of unknown origin, a method for screening such a drug, a method for treating a patient with the disease, a prophylactic drug, a method for preventing such a disease, a vaccine for the disease, a diagnostic drug, a diagnostic method, an experimental model for the disease and an experimental animal for the disease. [0002] Ulcerative colitis is one of the intractable diseases of digestive tracts and a unknown etiology. It has conventionally been regarded as an advantageous opinion that the ulcerative colitis would be a kind of autoimmune disease. For this reason, there have been used, for instance, steroid hormones, salazosulfapyridine and 5-ASA having an anti-inflammatory action. The administration of these drugs may clinically improve the symptoms of patients with this disease, but the disease recurs in most of cases, on a long term follow-up. Moreover, inflammatory findings still remain in both endoscopic and pathological findings in most of the cases of the disease, although the symptoms are improved. In other words, there has not yet been any drug for completely curing the disease. SUMMARY OF THE INVENTION [0003] Accordingly, it is an object of the present invention to provide a pharmaceutical composition for curing a patient with ulcerative colitis by eradication of Fusobacterium varium (F. varium). [0004] It is another object of the present invention to provide a method for screening a drug and treatment having an effect of eradication of F. varium and treating ulcerative colitis, a method for treating a patient with ulcerative colitis, a prophylactic drug for the disease with F. varium infection, a method for preventing any infection with Fusobacterium varium, a vaccine for the disease, an agent and a method for diagnosing the infection with the bacterium, and an experimental model and an experimental animal for the disease. [0005] The present inventors have examined patients with ulcerative colitis, and found that Fusobacterium varium cells are adhered to mucosa and invade into the mucus and ulcerative mucosa at high rates, the detection rate and value of the serum to the bacterium antibody is high, the amount thereof is large as compared with those observed for normal persons and patients suffering from other intestinal diseases and that the colic ulcer is caused due to butyric acid which is found to be produced by Fusobacterium varium. The F. varium itself has not been recognized to have any pathogenicity and have thus completed the present invention on the basis of the foregoing findings. [0006] Accordingly, the present invention provides a pharmaceutical composition for treating a patient with ulcerative colitis, which comprises a drug capable of selectively killing Fusobacterium varium. [0007] The present invention also provides a pharmaceutical composition for treating a patient with ulcerative colitis comprising a drug which can neutralize the toxin produced by Fusobacterium varium, a drug which can inhibit the adhesion of Fusobacterium varium to the intestinal mucosa or a drug which can inhibit the invasion of Fusobacterium varium into the intestinal mucosa as well as a vaccine for preventing ulcerative colitis comprising either of the foregoing drugs in an amount sufficient for preventing F. varium infection. [0008] The present invention likewise provides a method for screening a drug for selectively killing Fusobacterium varium, which comprises the step of administering a candidate drug in an experimental model of Fusobacterium varium-infection to thus select a drug capable of selectively killing the bacterium. [0009] The present invention also provides a method for screening a therapeutic agent for ulcerative colitis, which comprises the step of administering a candidate drug capable of selectively killing the bacterium to a patient suffering from ulcerative colitis and positive to Fusobacterium varium to thus select a drug capable of improving the symptoms of the patients with the disease. [0010] Although F. varium as commersal bacteria has not been recognized to be pathogenic, we found that colonic ulcers indued by enema of butyric acid which was produced by the bacterium. [0011] The present invention provides an animal as a model of ulcerative colitis obtained by administering a toxin produced by Fusobacterium varium to an animal. [0012] The present invention also provides an animal as a model for ulcerative colitis comprising Fusobacterium varium cells adhered to the intestinal mucosa. [0013] The present invention also provides a method for diagnosing ulcerative colitis comprising the step of detecting an antibody against Fusobacterium varium. [0014] The present invention further provides an agent for making a diagnosis of ulcerative colitis comprising an antibody, which has the highest detection sensitivity and the highest specificity, among a plurality of antibodies against Fusobacterium varium. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] Fusobacterium varium is a bacterium belonging to the genus Fusobacterium of the family Bacteroidaceae and was detected from the mucosa of a patient with ulcerative colitis at the active phase by bacterial cell culture and immunostaining. The rates of these detections were significantly higher than those observed for patients with ulcerative colitis at the remission stage, Crohn's disease, ischemic colitis, and colomic adenoma. Therefore, this bacterium is considered to be a causal bacterium or an exacerbation factor. From such information, it would be concluded that the patients with ulcerative colitis could be cured by administering a drug selectively killing this bacterium or an antimicrobial agent to remove the bacterial cells from the mucosa in the lesions. More specifically, there can be used antimicrobial agents having high susceptibility to Fusobacterium varium, such as tetracycline, penicillin, MNZ, imipenem, amoxicillin, cefmetazole, ampicillin, fosfomycin and chloramphenicol. [0016] It has been recognized that the toxins produced by Fusobacterium varium cells have toxicity to vero cells. Therefore, the toxins were analyzed and it was found that they were organic acids produced by Fusobacterium varium and that the principal component thereof was identified to be butyric acid. Thus, when butyric acid was injected into the rectum of a mouse, a lesion similar to ulcerative colitis was induced. Accordingly, if administering a drug, which can neutralize and/or adsorb the butyric acid to a patient, the development of any lesion may be prevented or such conditions may be treated. Specifically, an agent for adsorbing organic acids such as activated carbon can be employed. [0017] Since Fusobacterium varium cells are adhered to the surface mucosa of active ulcerative colitis, the crisis of ulcerative colitis can be prevented by inhibiting the adhesion of Fusobacterium varium cells to the affected mucosa even if Fusobacterium varium cells are present in the intestinal flora. Specifically, a drug for protecting mucosa such as sucralfate and ecabe sodium can be used. [0018] As an evidence that Fusobacterium varium cells invade from digestive tracts into the intestinal mucosa, an antibody (serum antibody) against Fusobacterium varium is detected in the sera of the patients with ulcerative colitis in a high detection rate and high antibody titers by the ELISA assay. There has recently been elucidated the invasion mechanism of various kinds of bacteria into mucosa. Bacteria act on the mucosal cells by themselves to thus make the cells produce receptors and then they invade into the cells. Fusobacterium varium cells may possess the same function. Moreover, it would be considered that if Fusobacterium varium cells invade into the mucosa, macrophages can be activated and they may be involved in the crisis and exacerbation of inflammation. Therefore, the inflammation can be controlled by blocking the process of the bacterial invasion into the mucosa. [0019] If a vaccine against Fusobacterium varium is developed, it would be possible to immediately eliminate Fusobacterium varium cells even if infected therewith and to prevent any crisis of ulcerative colitis or to inhibit the exacerbation of the symptoms, as in the case where the infection with pneumococcus can be inhibited by the vaccination with a pneumococcal vaccine. [0020] A target drug can be screened by establishing an experimental infection model using a sterilized animal or a small animal in which Fusobacterium varium cells are adhered to the colonic mucosa. In these animals, a candidate drug administered to the experimental animal, can be evaluated whether the candidate drug can selectively kill Fusobacterium varium cells or not, by the culture, immunostaining and the serum antibody titer. [0021] Patients with ulcerative colitis infected with Fusobacterium varium with are identified by diagnosing patients suffering from ulcerative colitis through the determination of the serum antibody titers, the cultivation of the mucosa or the immunostaining of affected mucosa, and then a candidate drug capable of selectively killing Fusobacterium varium is administered to the patients after obtaining the informed consent of patients. Thus, the effectiveness of the drug as a therapeutic agent for ulcerative colitis can be evaluated by the symptoms of the ulcerative colitis are, in fact, improved or not and by investigating the presence of side effects and safety of the drug. Continue reading about Therapeutic agent for ulcerative colitis... Full patent description for Therapeutic agent for ulcerative colitis Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Therapeutic agent for ulcerative colitis patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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