Use of a dipeptide for stimulating repair processes

Details Use of a dipeptide for stimulating repair processes Use of a dipeptide for stimulating repair processes

2001-02-21

2003-11-04

Brumback, Brenda (Department: 1654)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

C514S019300, C424S464000, C424S489000

Reexamination Certificate

active

06642201

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention is related to pharmacology, i.e. pharmaceuticals containing peptides and their compositions, which may find prophylactic and/or therapeutic employment in medicine as stimulators of tissue regeneration in case of pyo-inflammatory diseases; and post-operative complications, trophic disorders, diseases and injuries of skin and mucous membrane, consequences of radiation, thermal and chemical factors accompanied by the disturbances of repair processes.
The invention is concerned with application of dipeptide L-lysil-L-glutamic acid(L-Lys-L-Glu) as a substance stimulating repair processes in subjects, which need it.
2. Background Description
Among the drugs most analogous in application to the invented one there is a group of preparations stimulating metabolic processes: derivatives of pirimidine (Methyluacil, Pentoxyl) and biogenic preparations (Actovegin, Solcoseryl) (1).
Methyluracil drawback consists in cutaneous allergic reactions (urticaria eruption), sometimes headaches and dizziness. Pentoxyl oral application may induce dyspepsia due to irritating action of the drug. The detriment of Actovegin and Solcoseryl consists in a small amount of active substances in the drugs, prolonged treatment and limited application with respect to the stage of the wound process, as well as low efficacy in treatment of purulent wounds. These drugs produce largely stimulating effect on leukopoiesis.
There is known dipeptide L-Lys-L-Glu used as a component for peptide synthesis (2).
It is well known that L-Lys-L-Glu dipeptide displays immunomodulating activity (3). However, this activity of the dipeptide characterizes only the direction of its immunobiologcal action,. which is not an obvious and interrelated manifestation of the dipeptide properties with respect to the repair process, and does not specify indications for its clinical application. Below given examples of dipeptide L-Lys-L-Glu stimulating action on repair processes confirm objectively the absence of correlation between the known property and the claimed one.
SUMMARY OF THE INVENTION
The claimed invention is aimed at the solution of the problem of obtaining the substance of peptide origin capable of stimulating repair processes.
With respect to the invention, it is proposed to use a dipeptide with the following amino acid sequence: L-Lys-L-Glu, as a substance revealing a property to stimulate repair processes.
Dipeptide is obtained by a classical method of peptide synthesis in a solution (4).
This previously unknown property of L-Lys-L-Glu dipeptide to stimulate repair processes was found out in an experimental study.
With respect to the invention there is proposed a pharmaceutical peptide preparation able to stimulate regeneration which contains a pharmaceutically admissible carrier and an effective amount of dipeptide as an active basis representing a compound L-lysil-L-glutamic acid (L-Lys-L-Glu) or its chemical modification as salts.
With respect to the invention, pharmaceutical peptide preparation, stimulating repair processes, may contain salts according to amino group (acetate, hydrochloride, oxalate), or according to carboxyl groups (salts of metals—Natrium, Calcium, Lithium, Zinc, Magnesium and other organic and non-organic cations, for example ammonium triethylammonium.
The notion “pharmaceutical peptide preparation”, used in this application, implies the employment of any drug form, containing various pharmaceutical derivatives of the dipeptide, which reveals a therapeutic effect in treatment of the diseases requiring stimulation of tissue regeneration.
The notion “effective amount”, used in this application, implies the employment of such an amount of the active base, which in compliance with its quantitative indices of activity and toxicity, as well as with respect to the knowledge available, must be effective in this drug form. In order to obtain pharmaceutical compositions meeting the invention, the proposed dipeptide or its pharmaceutically applicable derivatives are blended as an active ingredient and a pharmaceutical carrier In accordance with accepted pharmacology methods of compounding.
The carrier may have various forms, which depend on the drug form of the preparation, desirable for administration, for example, parenteral, oral, intranasal or local (e.g. as applications or ointments).
All known pharmaceutical components may be used for preparation of compositions, in preferable doses, for oral or local application.
For parenteral (intranasal) administration, the carrier usually includes sterile water, although could be used other ingredients instrumental for stability or maintaining sterility.
In accordance with the invention, the dipeptide is active in case of its administration in doses 0.01-100 &mgr;kg/kg of the body weight, although lower (higher) doses, with respect to severity and character of the disease, could be used. The claimed pharmaccutical peptide preparation is proposed for parenteral, Intranasal, oral, and local application.
The invention embraces both method of stimulation of the regeneration processes for humans and animals who need such stimulation and pharmaceutical compositions for implementation of this method.
In accordance with the invention, the method of stimulation of the processes of regeneration by means of administration of the drug containing, as in active base, dipeptide L-lysil-L-glutamic acid (L-Lys-L-Glu) or its chemical modifications in the form of salts or other derivatives, is manifested in the activation of cell metabolism and the regulatory effect on the processes of proliferation and differentiation of cells of various tissues. The method includes prophylactic or therapeutic exposure of the subject which needs it, to the drug in doses 0.01-100 &mgr;kg/kg of the body weight at least once a day during the period necessary for reaching therapeutic effect—10-40 days with respect to the character and severity of the discase.
The invention involves prophylaxis and treatment of the diseases, which require stimulation of tissue regeneration: pyo-inflammatory processes, and post-surgical complications., trophic disturbances, skin and mucous diseases and lesions, after effects of radiation, thermal, and chemical factors, accompanied with the shift of repair processes.


REFERENCES:
patent: 0 165 492 (1985-12-01), None
patent: 2080120 (1997-05-01), None
patent: WO 95/03067 (1995-02-01), None
Liu et al. ‘Transplants of Fibroblast Genetically Modified to Express BDNF Promote Regeneration of Adult Rat Rubrospinal Axons and Recovery of Forelimb Function.’ J. of Neurosci. vol. 19, No. 11, pp. 4370-4387, 1999.*
Ehrman et al. ‘Lack of Regulation on the Heart Forming Region of Avian Embryos’ Developmental Biol. vol. 207, pp. 163-175 1999.*
Maden et al. ‘Retinoic Acid, A Regeneration-Inducing Molecule’ Developmental Dynamics, vol. 226, pp. 237-244. 2003.

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