Oligopeptides derived from C-reactive protein fragments

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

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530330, A61K 3800

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active

060572957

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BRIEF SUMMARY
The present invention relates to oligopeptides derived from fragments of the C-reactive protein (hereinafter CRP), and to their use as immuno-modulating agents, and in the therapy of cardiovascular and inflammatory diseases.
CRP is a protein generally having a very low blood concentration, which rises up to two thousand times following inflammatory processes [J. J. Morley and I. Kushner, Am. New York Acad. Sci., 389, 406-418 (1989)]. F. A. Robey et al., J. Biol. Chem., 262, No. 15, 7053-7057 (1987) disclose three CRP tetrapeptide sequences very similar to the ones of tuftsin. The chemically synthetized tetrapeptides stimulate the phagocytic leukocytes and the production of superoxide, and induce mononuclear cells to produce interleukin 1, in a tuftsin-like manner. Like tuftsin, the three CRP tetrapeptides are rapidly metabolized and inactivated by proteases in vivo.
It has been now surprisingly found that chemically modified analogues of said CRP tetrapeptide fragments are endowed with immuno-modulating activity and are useful in the therapy of cardiovascular and inflammatory diseases, for example in the therapy of the septic shock.
Therefore, the present invention relates to oligopeptides of formula (I) threonine, leucine, isoleucine, valine, sarcosine, alanine, glycine and (C.sub.2-6)acyl-glycine, or is absent; leucine, isoleucine, valine, lysine, ornithine, N.alpha.-substituted by at least one (C.sub.1-6)alkyl, benzyl or (C.sub.2-6)acyl group; proline, leucine, isoleucine and valine; arginine, leucine and glutamine, optionally amidated at the C-terminal position, or is an agmatine residue, or is absent; absent; said compounds being further characterized in that the side-chain groups of the above aminoacid residues and of the agmatine residue may be optionally substituted by one or more groups selected from the group consisting of (C.sub.1-6)-alkyl, benzyl or (C.sub.2-6)acyl; and each of said aminoacid residues may be in D- or L-form at the C.alpha., or in form of one of the possible diastereoisomers or enantiomers;
A preferred group of compounds according to the invention are the ones of formula (I) wherein A.sub.1 is an aminoacid residue selected from the group consisting of glycine, threonine, leucine, isoleucine, valine, sarcosine, alanine (C.sub.2-6)acyl-glycine, or is absent; A.sub.2 is an aminoacid residue selected from the group consisting of lysine N.alpha.-substituted by a (C.sub.1-6)alkyl, benzyl or (C.sub.2-6)acyl group; A.sub.3 is proline; A.sub.4 is glutamine, leucine, arginine, optionally amidated at the C-terminal position, or an agmatine residue, or is absent; said aminoacid residue and of the agmatine residue may be optionally substituted by one or more substituents selected from the group consisting of (C.sub.1-6)alkyl, benzyl or (C.sub.2-6)acyl; and each of said aminoacid residue may be in D or L form on the C.alpha., or in form of one of the possible diastereoisomers or enantiomers;
As (C.sub.1-6)alkyl it is intended a group such as methyl, ethyl, propyl, i-propyl, butyl, sec-butyl, tert.-butyl, n-pentyl, 3-methyl-pentyl, n-hexyl group, and the relevant positional isomers. As (C.sub.2-6)acyl it is intended a group such as formyl, acetyl, propionyl, butyryl, pentanoyl, hexanoyl and the relevant positional isomers.
Another object of the present invention relates to the use of the oligopeptides of formula (I) as immuno-modulating agents, and in the therapy of cardiovascular and inflammatory diseases, as the septic shock.
The compounds of the general formula (I) may be prepared employing peptide synthesis procedures, both in solid phase or in solution, known to the skilled in the art [see, for example, Merrifield, R. B., Biochemistry, 3, 1385 (1964)]. Unless otherwise mentioned, the aminoacid residues are intended to be used in L-configuration at the C.alpha..
Preferably, the synthesis is carried out in solution starting from the selected aminoacid and assembling the oligopeptide by a step-by-step addition of the desired aminoacids. Anyway, pre-constituted di- or tripeptide units may als

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