Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-07-15
2002-01-08
Carlson, Karen Cochrane (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C514S012200, C514S014800, C514S025000, C514S501000, C424S435000, C424S049000, C424S185100, C530S300000, C530S350000, C530S324000, C530S327000, C530S399000, C435S069100, C435S069700, C435S006120, C435S325000, C435S374000, C435S378000
Reexamination Certificate
active
06337315
ABSTRACT:
CROSS-REFERENCE TO PRIORITY APPLICATION
This application claims priority under 35 U.S.C. §119 of FR-98/09055, filed Jul. 15, 1998, assigned to the assignee hereof and hereby expressly incorporated by reference.
BACKGROUND OF THE INVENTION
1. Technical Field of the Invention
The present invention relates to novel compositions comprising an effective anti-inflammatory amount of at least one peptide derivative of &agr;-type melanocyte stimulating hormone (&agr;-MSH), or of any functional biological equivalent thereof, formulated intimately admixed with at least one algal extract of marine origin. This invention also relates to controlling disorders involving an inflammatory process and to cosmetic treatments by administering the subject novel compositions to individuals in need of such treatments.
2. Description of the Prior Art
Inflammation (or the inflammatory process) is a set of biological reactions which exist throughout the animal kingdom. In man, two patients out of three exhibit an inflammatory syndrome. The inflammation may be localized. It may be defined as the first response to any local attack by means of a series of non-specific reactions which are triggered whatever the initial cause and which take place in three consecutive steps: vascular step, cellulovascular step and tissue fibrosis step.
There is a symptomatic gradation of the inflammation, which transforms from the sensation of skin discomfort, of stretching and of itching to swelling, pain, redness and/or heat. These symptoms are generally due to infiltration of the injured tissues with an edema and/or to vasodilatation of the capillaries.
The signs of the inflammation can extend as far as fever, a state of general malaise and/or an increase in the concentration of certain proteins of the blood plasma.
Inflammation is a phenomenon which involves, inter alia, a series of local cell reactions and the release of cytokines and other mediators such as substance P, prostaglandins, leukotrienes, bradykinin, histamine or serotonin.
The inflammation is manifested by a change in blood flow with, at the site which is under attack, an increase in vascular permeability leading to leakage of plasma proteins towards the extracellular fluid as well as an extravasation of blood cells, in particular leucocytes, neutrophils and macrophages, towards the inflammatory site.
These phenomena are in fact the result of the action of inflammation mediators. Factors which are involved in these inflammatory phenomena, and which are representative, are the cytokines, including, in particular, interleukin 1-&agr;, interleukin 1-&bgr; and interleukin 6, the &agr; and &bgr; tumor necrosis factors (TNF &agr; and TNF &bgr;), the chemokines, such as interleukin 8 or the monocyte chemotactic and activating factor (MCAF), or else other chemotactic factors which are responsible for recruiting lymphocytic cells, monocytic cells, Langerhans cells or basephilic cells at the inflammatory site, such as the B-4 leukotrienes, or else other factors involved in the inflammatory cascade, such as arachidonic acid or the prostaglandins, including, in particular, the E2 prostaglandins.
The inflammatory phenomena are associated with a large number of disorders which range from simple skin discomfort to pathological disease states. The following are exemplary: skin disorders such as sensitive skins, skin discomfort, skin stretching, skin itching, skin swelling, skin pain, skin flushing, heat sensation of the skin, erythemas, in particular due to ultraviolet rays, pruritus, erythema nodosum, urticaria, insect bites, allergies, alopecia in its inflammatory phases, articular ailments such as rheumatoid arthritis, osteoarthritis, tendinitis, periarthritis, spondylarthropathies or the articular impairments of the chronic enteropathies, rheumatic ailments such as acute rheumatic fever or rheumatoid arthritis, pulmonary ailments such as emphysema, systemic mastocytosis, psoriasis, or else other dermatological ailments such as atrophic polyctondritis, erythermalgia, or necrobiosis lipoidica. Systemic lupus erythematosus is also illustrative.
Whatever the phenomenon envisaged, all of these mechanisms exhibit a common manifestation, which is expressed by an inflammatory reaction, the terminal facet of which can be measured by the release, by the mastocytic, endothelial, keratinocyte, fibroblast, melarocytic and/or Langerhans cells of the skin, of at least one inflammation mediator such as histamine, serotonin, heparin, leukotrienes, prostaglandins, cytokines, nitrogen monoxide or reactive oxygen species.
In particular, it is known to this art that, in response to a proinflammatory signal (chemokines and cytokines such as interleukin I), the keratinocytes in the superficial layers of the skin release interleukin 8, which contributes to the triggering of the inflammatory response.
The pharmaceutical industry has long sought to develop active agents effective for treating inflammation. Vast numbers of such active agents are known to this art and are described under the designations steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs (SAID and NSAID); compare, for example, the text by Schorderet and Dayer “Pharmacologie. Des concepts fondamentaux aux applications thérapeutiques” (Pharmacology. Concepts which are fundamental to therapeutic applications), 1992, chapter 37, pages 541-561. 2nd Edition, Frison-Roche/Slatkine editors.
Aside from the fact that the known anti-inflammatory agents often exhibit not inconsiderable side effects, serious need continues to exist for novel compounds/formulations eliciting anti-inflammatory activity, in particular for minor skin disorders/afflictions such as, for example, sensitive skins, skin discomfort, skin stretching, skin itching, skin swelling, skin pain, skin flushing, heat sensation of the skin, erythemas, in particular due to ultraviolet rays, and pruritus.
SUMMARY OF THE INVENTION
Accordingly, a major object of the present invention is the provision of novel anti-inflammatory active agents which are conspicuously devoid of substantial adverse side effects.
Briefly, the present invention features novel anti-inflammatory compositions comprising, as the active principle therein, an effective amount of at least one peptide derivative of &agr;-type melanocyte stimulating hormone (&agr;-MSH), or any functional biological equivalent thereof, formulated together with at least one algal extract of marine origin.
DETAILED DESCRIPTION OF BEST MODE AND SPECIFIC/PREFERRED EMBODIMENTS OF THE INVENTION
More particularly according to the present invention, the peptide derivative is a derivative of &agr;-type melanocyte stimulating hormone (&agr;-MSH) or melanotropin. While &agr;-MSH was originally described as being produced by the pituitary gland, the brain in general, the blood, the skin and other tissues are also able to produce &agr;-MSH.
Thus, it has been shown by Schauer et al. (
J. Clin. Invest.,
93, May 1994 pp. 2258-2262) that the keratinocytes of the epidermis are a source of &agr;-MSH. Receptors for &agr;-MSH are present in a large number of cell types, in particular in the hair follicles of the human scalp (
Pigment Cell Res.,
4:193-8, 1991).
(1-13) &agr;-MSH is known for its antipyretic activity, its anti-inflammatory activity and its pigmentation-promoting activity. This neuropeptide is recognized for inhibiting the inflammation which is induced by cytokines and other inflammation mediators, as well as by irritants.
The antipyretic signal of &agr;-MSH is situated at its carboxy terminal sequence and can be mimicked by the 11-13 carboxy terminal tripeptide (L)Lys(L)Pro(L)Val (Watanabe et al.,
Brain Research Bulletin.,
Vol. 32. pp. 311-314, 1993).
Thus, U.S. Pat. No. 5,028,592 and WO-88/00833 describe the use of the tripeptide (L or D)Lys-(L)Pro-(L or D)Val in an anti-inflammatory therapeutic treatment and the preparation of such a drug for treating inflammation.
Other derivatives of &agr;-MSH are recognized for their anti-inflammatory activity. For example, WO-95/08564, hereby expressly incorporated by ref
Billoni Nelly
Breton Lionel
Bui-Bertrand Lien
Mahe Yann
Carlson Karen Cochrane
Robinson Hope A.
Societe L'Oreal S.A.
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