Use of interleukin-8 for inducing cervical ripening

Details Use of interleukin-8 for inducing cervical ripening Use of interleukin-8 for inducing cervical ripening

1995-02-23

1997-04-29

Achutamurthy, Ponnathapura

Drug, bio-affecting and body treating compositions

Lymphokine

Interleukin

514 12, A61K 3820

Patent

active

056246706

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

1. Field of the Invention:
This invention relates to a treatment for ripening of the cervix, particularly in the induction of labour to assist mammals to give birth or in connection with surgical or diagnostic procedure.
2. Description of the Related Art:
Parturition (expulsion of the fetus from the uterus), requires both contractions of the myometrium, the smooth muscle of the uterus, and a softening of the connective tissue of the cervix, so that it will stretch and dilate sufficiently to allow the fetus to be expelled. This softening is known as "ripening".
The current preferred method of cervical ripening is by the use of prostaglandin E.sub.2. This is used as a vaginal gel or tablet or as a gel placed in the cervix. One worry about the use of prostaglandin E.sub.2 is that there is a possibility of hyperstimulation of the uterus, leading to excessively strong myometrial contractions before the cervix is ripened and therefore before a comfortable or safe birth is possible. The ideal preparation would soften and efface the cervix without causing myometrial contractions. This would allow the subsequent contractions (induceable if necessary with a small dose of prostaglandin) to deliver the baby with a minimum of resistance. There is good evidence from animal experiments that the antiprogestins such as RU486 would meet these requirements, but the problem with this drug is that is has associated antiglucocorticoid activity which might be detrimental to the fetus.


SUMMARY OF THE INVENTION

It has now surprisingly been found that the final common pathway in prostaglandin and antiprogestin action is the release of interleukin-8. It follows that this compound could be used to induce labour and ripen the cervix. Its use would be without the myometrial contractility associated with the use of prostaglandin and would not prejudice the fetus. During birth the cervix normally ripens without help from outside. But the compound of the invention will help during the normal ripening and during all birth situation in which the ripening is not sufficient. Further the compound of the invention will support the normal ripening to make that process of the birth easier for women.
The advantage of the use of interleukin-8 is the reduction or the avoiding pain during birth, abortion, surgical and diagnostic treatment.
The amino acid sequence of natural interleukin-8 differs from species to species. The proteins differs so much that the interleukin-8 from one species might not work in another species. A test will show in each case whether the protein of one species is compatible with use in another species. Therefore, the effective amount of the protein of the invention will depend upon the origin of the protein and the species to which the protein is administered.
The invention provides the use of (aa) interleukin-8 or (bb) a functional derivative thereof for manufacture of a medicament for inducing cervical ripening in a female mammal. Female mammal can be human being or an aminal, preferred human beings. Further the invention comprises a method for inducing cervical ripening in female human or animal in a need of such inducing comprising administering to said animal a safe and effective amount of (aa) interleukin-8 or (bb) a functional derivative thereof for said ripening.
The invention provides the use of the compounds of the invention in connection with birth or abortion. In this situation of pregnancy the cervix is pre-treated. The hormones during pregnancy alter the cervix which is then inclined to respond effectively to other stimulants. Further the invention provides the use of the compounds of the invention in connection with surgical procedure and diagnostic procedure. Therefore, the compounds of the invention can be used for the following indications: with sequential treatment with oxytocin or similar agents), fetal malformation); (preferred second trimester abortion), female to assist for surgical or diagnostic procedure, and fertilisation. In principle the compound can be used for hum

REFERENCES:
patent: 4870067 (1989-09-01), Chwalisz et al.
Kelly et al, "Choriodecidual Production of Interleukin-8 and Mechanism of Parturition", The Lancet, vol. 339, No. 8796, 28 Mar. 1992, London, GB.
Romero et al, "Neutrophil Attractant/Activating Peptide-1/Interleukin-8 in Term and Preterm Parturition", American Journal of Obstetrics and Gynecology, vol. 165, No. 4, Oct. 1991, pp. 813-820.
Colditz, "Effect of Exogenous Prostaglandin E2 and Actinomycin D on Plasma Leakage Induced by Neutrophil-Activating Peptide-1/Interleukin-8", Immunology and Cell Biology, vol. 68, Dec. l990, pp. 397-403.
Ulmsten Ulf et al, "A New Gel For Intracervical Application of Prostaglandin E2", Chemical Abstracts, vol. 92, No. 7, 18 Feb. 1980, Columbus, Ohio, US.
Prostaglandins Jul. 1987 vol. 34 No. 1 pp. 119-Rath et al "The Role of Collagenases and Proteases in Prostaglandin-induced Cervical Ripening".
Contraception Mar. 1990 vol. 41 No. 3 p. 283 R.o slashed.destad et al "Induced Cervical Ripening . . . ".
Cytokine vol. 3 No. 1 Jan. 1991 p 21-27 Rot "Chemotactic Potency of Recombinant . . . ".

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