Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1995-03-31
1998-08-18
Tsang, Cecilia J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 9, 514 11, 514 15, 514 16, 514 17, 514 18, 530328, 530329, 530330, A61K 3800
Patent
active
057958580
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the treatment or prevention of Crohn's Disease and/or ulcerative colitis.
BACKGROUND OF THE INVENTION
Crohn's Disease, or Regional Ileitis, is the term applied to a condition in which there is an inflammation of an area of the small intestine. This is usually accompanied by colicky abdominal pain, irregularity of the bowels, loss of weight and slight fever. The abdomen is generally distended and the thickened intestine may be felt. The narrowed intestinal canal may become obstructed, necessitating immediate operation. The cause of the disease is unknown. The primary lesion is hyperplasia of the lymph tissue in the submucosa of the intestine and in the lymph glands.
As the cause is not known, there is as yet no specific treatment. In the early stages, current treatment (or at least management) is medical, including a high-vitamin, low-residue diet, sulphonamides and antibiotics. Promising results have been reported from the use of corticosteroids in some cases. Operation, consisting of removal of the damaged section of gut, is reserved for cases which do not respond to medical treatment. Even in cases apparently successfully operated on, recurrence tends to occur in 15 percent or more of cases.
Short of surgery, therefore, corticosteroid therapy is to date the most successful remedial treatment for Crohn's Disease. However, steroid chemotherapy is not without its drawbacks and hazards. Goodman and Gilman state, in "The Pharmacological Basis of Therapeutics", Seventh Edition, 1985: anti-inflammatory effects is palliative therapy; the underlying cause of the disease remains; the inflammatory manifestations are merely suppressed. It is this suppression of inflammation and its consequence that has made the corticosteroids such valuable therapeutic agents--indeed, at times lifesaving. It is also this property that gives them a nearly unique potential for therapeutic disaster."
Crohn's Disease is a chronic condition of the gastrointestinal tract and infects most commonly the ileum, colon or a combination of both. It is distinguished from ulcerative colitis by a differential diagnosis:
Acute appendicitis
Yersinia infection
Lymphoma
Ulcerative jejunoileitis
Infective colitis
Ischaemic colitis
Radiation colitis
Other causes of bleeding, e.g. colonic polyps or carcinoma.
DESCRIPTION OF THE INVENTION
It has now been discovered that a group of non-steroidal compounds, namely peptide T and its derivatives and analogues, are useful in the prevention and treatment of Crohn's Disease and/or ulcerative colitis.
Originally, many of the peptides useful in the invention were described as being effective in the prevention of infection and replication of HIV in vitro, see EP-A-0249390, EP-A-0249394 and WO-A-8809338, all of which are incorporated by reference to the maximum extent allowed by law, as are all other documents referred to in this specification. The compounds useful in the invention are also the subject of pending and as yet unpublished PCT patent application No. PCT/GB93/00649, filed 29 Mar. 1993. All compounds disclosed in these specifications are useful for the present invention. The original peptide has its basic point of origin in the octapeptide Ala--Ser--Thr--Thr--Thr--Asn--Tyr--Thr (SEQ ID NO: 1) It is called Peptide T because 50% of the amino acid residues are threonine.
Accordingly in a first aspect the present invention, consists in a method of treating or preventing Crohn's Disease and/or ulcerative colitis in a subject comprising administering to the subject a therapeutic amount of a linear or cyclic peptide of General Formula 1:
I--A--B--C--D--E--F--G--H--II (General Formula 1) (SEQ ID NO: 2)
wherein A is Ala, Gly, Val, Ser, Thr or absent,
B is Ala, Gly, Val, Ser, Thr or absent
C is Ser, Thr or absent,
D is Ser, Thr, Asn, Glu, Arg, Ile, Leu or absent,
E is Ser, Thr, Asp or absent,
F is Thr, Ser, Asn, Arg, Gln, Lys, Trp or absent,
G is Tyr, Phe, Trp, Leu, Met, Ile or absent,
H is Thr, Arg, Gly, Met, Met(O), Cys, Thr, Gly or absent,
I is Cys or absent,
II is Cys or ab
Michaelis Jurgen
Sleigh Merilyn J.
Delacroix-Muirheid C.
Peptide Technology Limited
Tsang Cecilia J.
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