Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1995-03-23
1999-09-14
Tsang, Cecilia J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 12, 514822, 514885, A61K 3800
Patent
active
059522968
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The invention relates to methods of using relaxin (RLX) as a pharmaceutical agent for the treatment of particular disease.
Relaxin is a hormone secreted by the ovaries especially during pregnancy. Its structure is very similar to insulin and it is different for each species of animals. Its known activities are linked to reproduction and specifically to pregnancy and delivery. This hormone is recognized as being capable of inhibiting spontaneous contractions of the uterus during pregnancy and of provoking the enlargement of the pubic symphysis and cervix at delivery time.
BACKGROUND ART
The availability of pure preparations of relaxin has always been quite limited due to the difficulty of isolating and purifying it, as well as to the scarcity of organs from which to extract it (Bryant Greenwood G. D., Endocrine Review, 3-62-1982). These limitations and the difficulties in preserving the biological activity of the hormone produced a progressive lack of interest until an almost complete oblivion of relaxin, and finally even the disbelief in relaxin existence.
The purification and sequentiation of relaxin and its production by genetic engineering, obtained from 1974 to 1983, offered new possibilities to finally research and understand the biology and the role of this hormone. In this respect see Sherwood et al., Arch. Biochem. Biophys. 160-185-1974; James et al., Nature 267, 554, 1974; Hudson et al., Nature, 301, 628, 1983; Bigazzi M. et al, Biology of Relaxin and its role in the human, International Congress Series 610, Excerpta Medica-Amsterdam-1993.
Actually, there is a bulk of evidence that RLX is a multifunctional hormone, efficacious on reproductive organs, mammary glands and connective tissues, but so far no clinical use has been realized.
A new possible target for RLX could be the cardiovascular system. The cardiovascular system can be divided into three different main sections: negative way to circulation through the hemostatic system and through the concentration of various substances such as lipids, electrolytes, water and the like.
Some diseases or dysfunctions of the cardiovascular system can occur separately only in one of these main sections without affecting directly the others (such as the contractile failure and rhythm disturbances of the heart, some congenital abnormalities of the vessels or alterations in the hemostatic chain as thrombophilic or hemophilic diseases etc.).
Some of the more frequent circulatory diseases can begin in one section but involve soon also other parts of the system. This is the case of arteriosclerosis in which both the alterations of the blood composition and of the arterial walls are responsible for the pathogenesis and clinical features of the disease.
The circulatory disease which derives from arteriosclerotic processes represents one of the major problems of mankind. In fact it is the most frequent cause of death, at least in 4% of the population (especially from myocardial or cerebral infarction). This explains the great interest of researchers in this field.
Presently many different pharmacological tools are known and used to correct the thrombo-ischemic diseases of circulation, separately aimed at vessel dilation or blood clotting correction, clot dissolution, blood lipid reduction and so on.
The effects of RLX on the heart were discovered in 1990 by Osheroff et al., see Osheroff PL et al., Proc. Natl. Acad. Sci. USA; 1992.89: 2384-2388; and U.S. Pat. No. 5,166,191.
They described the binding of RLX to heart atria and an increase of the rhythm and contractions of the in vitro isolated atria. From these experiments they hypothesized a possible role of RLX in dysfunctions of heart rhythm and in diseases concerning heart contraction, such as congestive heart failure.
Some observations have been done on circulation. It has been noted that the Raynaud's lesions completely disappear during early pregnancy. Early clinical studies made by Casten and Allon in 1958 and 1960 with ovine preparation of RLX of poor purity and uncertain biologica
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Delacroix-Muirheid C.
Tsang Cecilia J.
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