Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1994-02-17
1996-07-09
Chan, Christina Y.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 21, 530303, 530399, C07K 1400, C07K 1300, A61K 3827, A61K 3800
Patent
active
055344933
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the use of IGF-I and/or IGF-II or effective analogues thereof for the manufacture of a medicament adopted for oral or any gastrointestinal route of administration for prevention or treatment of pancreatic disorders and insufficiency. It also relates to composition comprising exogenous human or animal IGF-I and/or IGF-II or effective analogues thereof comprising foodstuff for oral administration, preferably in admixture with artificial or natural milk or colostrum. The invention may be applied both in man and in animals.
INTRODUCTION AND PRIOR ART
Insulin-like growth factor1 (IGF-I) and insulin-like growth factor 2 (IGF-II) are peptides present in plasma and other body fluids. They show 64% homology of their primary sequences and comprise 70 and 67 amino acids respectively, including 3 disulphide bonds. They can stimulate growth of a wide range of cell types. IGF-I but not IGF-II mediates the effects of growth hormone on skeletal growth. Both IGF-I and IGF-II have been purified from human plasma and their complete amino acid sequences are known. Sequences with extensive homologies to human IGF-I and IGF-II are present in IGF-I and IGF-II purified from plasma of other species. IGF-I and IGF-II have both systemic and local effects and appear mostly associated with different specific binding problems, six of which are sequenced and are termed IGFBP1, IGFBP2, IGFBP3, IGFBP4, IGFBP5 and IGFBP6. These appear to modulate, the biological functions and availability of IGF-I and IGF-II in both a positive and negative manner. Analogues with changed affinities for the binding proteins have been produced and changes of biological activities related to sequence variation have been found. Both IGF-I and IGF-II appear to act mainly by interactions with the IGF-type 1 receptor exposed on the outer surface of plasma membranes in many different cell types--however relative specificity of action may be found because of the influence of binding proteins. Further IGF-II may have distinct actions as it alone binds to a distinct and unrelated type 2 receptor also found on cell membranes. Further binding of both IGF-I and IGF-II to insulin receptors also seems to be of importance.
Because of the scarcity of purified plasma IGF-I and IGF-II there was a great necessity to develop methodology for the commercial scale production of IGF-I and IGF-II. Nowadays such large scale production can readily be achieved by using recombinant DNA techniques. As a result of studies with preparations of recombinant DNA derived IGF-I it has been demonstrated that it promotes skeletal growth and skeletal muscle protein synthesis. Moreover IGF-I is also effective for the treatment or prevention of catabolic states (Swedish patent application SE 9002731-9). IGF-II has also been shown to antagonise some metabolic actions of IGF-I (Koea et al Endocrinology (1992). 130, 2423-2425). Ballard et al, WO 91/12018 have disclosed the therapeutic use of IGF-I for gastrointestinal disease or the treatment of the shortened gut after surgery. Ballard provides no evidence of activity or effects on pancreatic size or growth following oral administration.
It has previously been demonstrated that both type 1 and type 2 IGF receptors are present in the gastrointestinal tract and that oral IGF-I and IGF-II affect jejunal enzymes following repeated administration in older suckling rats, but no effect on intestinal growth was observed. (Young et al. Digestion 46 , 1990, Suppl. 2, 240-252). It has also been reported that systemically (i.e. subcutaneous or intramuscular or intravenous) administered IGF-I can increase gastrointestinal weight, but pancreatic growth was riot assessed.
Heinze-Erian et al, Endocrinology, Vol 129, No 4, 1769, 1991 reports that there is an essential role for both IGF receptors in the regulation of cell mitogenesis and growth. Rivard Net al, ReguI-Pept 1991, Jun 11, Vol 34(1), 13-23 reports that intravenous injected IGF-I may have an effect on pancreatic and duodenal cell content of somatostatin and Grey Vet al, Mol-
REFERENCES:
Heinz-Erian et al., Endocrinology, 1991, p. 1769.
Schoker et al., Endocrinology, vol. 126(2), Feb. 1990, pp. 1125-1132.
Young, et al., Insulin-Like Growth Factors and the Developing and Mature Rat Small Intestine: Receptors and Biological Actions, Digestion, 1990 (46), pp. 240-252.
Rivard, et al., Negative Control by Sandostatin on Pancreatic and Duodenal Growth: A Possible Implication of Insulin-Like Growth Factor I, Regulatory Peptides, 1991 (34), pp. 13-23.
Grey, et al., Insulin-like Growth Factor II/Mannose-6-Phosphate Receptors Are Transiently Increased in the Rat Distal Intestinal Epithelium After Resection, Molecular and Cellular Endocrinology, 1991 (75), pp. 221-227.
Heinz-Erian, et al., Identification and In Situ Localization of the Insulin-Like Growth Factor-II, Endocrinology, 1991, p. 1769.
Moessner, et al., Chem. Abstr. 108 (1988), 69411a.
Williams, et al., Chem. Abstr. 100 (1984), 133010h.
Koenuma, et al., Insulin and Insulin-Like Growth Factor 1 Stimulate Proliferation of Metastatic Variants of Colon Carcinoma 26, Japan J. Cancer Res. 1989, Jan., vol. 80(1), pp. 51-58 (Abstract).
Culouscou, Purification of a Colon Cancer Cell Growth Inhibitor and its Identification as an Insulin-Like Growth Factor Binding Protein, Cancer-Ref. 1991, Jun. 1, vol. 51(11), pp. 2813-2819 (Abstract).
Gluckman Peter D.
Mellor David J.
Chan Christina Y.
Pharmacia AB
Touzeau Phynn
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