Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ortho-hydroxybenzoic acid or derivative doai
Reexamination Certificate
1999-11-17
2001-08-21
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ortho-hydroxybenzoic acid or derivative doai
C514S029000, C514S034000, C514S312000, C514S315000, C514S317000, C514S374000
Reexamination Certificate
active
06277836
ABSTRACT:
TECHNICAL FIELD
The invention relates to compositions and methods for the treatment of inflammatory bowel disease, such as Crohn's disease.
BACKGROUND OF THE INVENTION
Inflammatory bowel disease (IBD) is a disorder of unknown aetiology characterised typically by diarrhoea, cramping, abdominal pains, weight loss and rectal bleeding. It encompasses such disorders as Crohn's disease, ulcerative colitis, indeterminate colitis, microscopic colitis and collagenous colitis. Its cause is unknown. However, in the past there has been some evidence that
Mycobacterium paratuberculosis
(Mp) and perhaps its various sub-strains, may play an infective role by entering the cells which make up the bowel wall. The source of this bacterium is unclear but may reside in other animals such as sheep, cattle, rabbits, as well as other humans. It may be transmitted to people perhaps via milk, contaminated water supplies, poorly cooked meat, etc. Although there has been long-standing controversy about the involvement of Mp in causation of Crohn's disease, recent applications of PCR usage are beginning to confirm that most Crohn's cases are indeed infected with this organism which is likely to be the causal infective agent. In the past, therapy directed at the eradication of Mp by using combined anti-TB drugs eg INH, pyrazinamide, streptomycin, ethambutol, rifampicin and PAS have been generally of little help to patients. In other words, although transient improvements in a proportion of patients did occur, no patient was cured. In fact, even if Mp had been the cause of this disease there was no effective therapy available for Mp since it was an “atypical mycobacterium” and for atypical mycobacteria there was no known therapy. Furthermore, since
Mycobacterium paratuberculosis
has a long division time multiple antimicrobial drugs are required to the treat the infection which has to be carried out for a long period of time—akin to the treatment used in the therapy of
Mycobacterium tuberculosis
. Furthermore,
Mycobacterium tuberculosis
therapy with the current drugs results in resistant strains forming. Such resistant strains do not become eradicated with known antimicrobial agents. Hence, there is no known effective cure for resistant TB.
Accordingly, there is a need for an effective treatment of inflammatory bowel disease, and in particular Crohn's disease. It is an object of this invention to provide such a treatment.
Surprisingly, the present inventor has discovered that the metabolism of the mycobacteria believed to be responsible for the symptoms of inflammatory bowel disorders may be inhibited long enough to cure the infection and thus relieve the symptoms, by administering to the patient a combination of anti-atypical mycobacterial agents and/or an immunising amount of a mycobacterial product.
SUMMARY OF THE INVENTION
The present invention provides a method and composition of medications used to treat inflammatory bowel disease including Crohn's disease and colitis. The methods of the invention result in a cure of the infection and reversal of the clinical condition. The invention further provides combinations of anti-atypical mycobacterial agents effective against the atypical mycobacterial strains. It also provides a method of potentiating the anti-atypical mycobacterial agents in treatment of inflammatory bowel disease by immunising patients with extracts of non-pathogenic mycobacteria.
Thus, in a first embodiment, the invention provides a composition for the treatment of inflammatory bowel disease including three or more anti-atypical mycobacterial agents.
In a second embodiment, the invention provides a method for the treatment of inflammatory bowel disease including administering to a patient in need of said treatment an effective amount of at least three anti-atypical mycobacterial agents.
In a third embodiment, the invention provides a method for the treatment of inflammatory bowel disease including administering to a patient in need of said treatment an effective amount of at least three anti-atypical mycobacterial agents and immunising the patient with an immunising amount of a mycobacterial extract or product.
In a fourth embodiment, the invention provides a method for the treatment of inflammatory bowel disease including administering to a patient in need of said treatment an immunising amount of a mycobacterial extract or product.
In further embodiments, the invention provides (a) the use of a composition comprising three or more anti-atypical mycobacterial agents for the manufacture of a medicament for the treatment of inflammatory bowel disease; (b) the use of a composition including at least three anti-atypical mycobacterial agents and a mycobacterial extract or product for the manufacture of a medicament for the treatment of inflammatory bowel disease; and (c) the use of a mycobacterial extract or product for the manufacture of a medicament for the treatment of inflammatory bowel disease.
DESCRIPTION OF THE INVENTION
This invention discloses a method of use and compositions useful in the treatment of Crohn's disease and colitis and of other inflammatory bowel diseases using various combinations of anti-atypical mycobacterial drugs.
In the composition of the first embodiment of the invention, or the methods of the second or third embodiments, valid combinations of anti-atypical mycobacterial agents include triple (three drugs) groupings of anti-atypical mycobacterial agents, or indeed larger combinations for exceptional situations, eg where resistant strains emerge. Four, five and even six drug combinations may be required in patients with resistant
Mycobacterium paratuberculosis
strains. Suitable anti-atypical mycobacterial agents include, but are not limited to, clarithromycin, rifabutin, rifampicin, rifapentene, azithromycin, roxithromycin, cefazoline, minocyclin, streptomycin, amikacin, clofazimine, ethambutol, ofloxacin, sparfloxacin, levofloxacin, pefloxacin, grepafloxacin, trovafioxacin, norfloxicin, enoxacin, lomefloxacin, ciprofloxacin and oxazolidinone. These may be co-used with one or more 5-aminosalicylic acid compounds or 4-aminosalicylic acid compounds such as mesalazine, olsalazine, salazopyrin or para-amino salicylic acid. Typically, at least one of the anti-atypical mycobacterial agents is rifabutin or clarithromycin. More typically, the composition of the first embodiment includes rifabutin, clarithromycin and clofazimine. Similarly, the methods of the second and third embodiments usually involve the administration to the patient of an effective amount of a combination of rifabutin, clarithromycin, and clofazimine.
Surprisingly, the combination of three or more anti-atypical mycobacterial agents exhibits a substantially greater effect against inflammatory bowel disease than would have been expected from each anti-atypical mycobacterial agent alone.
Typically, the composition of the present invention may include between 10-500 mg of each of three or more anti-atypical mycobacterial agents. More typically, the composition of the present invention may include between 10-250 mg of each of three or more anti-atypical mycobacterial agents. Even more typically, the composition of the present invention may include rifabutin present at between 50-250 mg, more typically, approximately 15 mg, clarithromycin at between 200-30 mg, more typically, approximately 250 mg, and clofazimine at between 10-150 mg, more typically, approximately 50 mg. Further, other anti-atypical mycobacterial agents may be present in amounts in accordance with known dosages.
Typically, the composition of the present invention may be available in the form of a tablet containing each of three or more anti-atypical mycobacterial agents present in a compressed powdered form. Alternatively, the composition of the present invention may be available in the form of a tablet capsule containing one or more of the anti-atypical mycobacterial agents in a microencapsulated form. As another possibility, the composition of the present invention may be available in the form o
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